Sample records for good manufacture practices

  1. 21 CFR 110.5 - Current good manufacturing practice.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 2 2010-04-01 2010-04-01 false Current good manufacturing practice. 110.5 Section...) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD General Provisions § 110.5 Current good manufacturing practice. (a) The criteria and...

  2. 21 CFR 225.1 - Current good manufacturing practice.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Current good manufacturing practice. 225.1 Section...) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS General Provisions § 225.1 Current good manufacturing practice. (a) Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act...

  3. 21 CFR 226.1 - Current good manufacturing practice.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Current good manufacturing practice. 226.1 Section...) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED ARTICLES General Provisions § 226.1 Current good manufacturing practice. (a) The criteria in §§ 226.10 through 226.115, inclusive...

  4. 21 CFR 113.5 - Current good manufacturing practice.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 2 2010-04-01 2010-04-01 false Current good manufacturing practice. 113.5 Section... CONTAINERS General Provisions § 113.5 Current good manufacturing practice. The criteria in §§ 113.10, 113.40..., methods, practices, and controls used by the commercial processor in the manufacture, processing, or...

  5. 21 CFR 129.1 - Current good manufacturing practice.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 2 2010-04-01 2010-04-01 false Current good manufacturing practice. 129.1 Section... Current good manufacturing practice. The applicable criteria in part 110 of this chapter, as well as the..., methods, practices, and controls used in the processing, bottling, holding, and shipping of bottled...

  6. 21 CFR 123.5 - Current good manufacturing practice.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 2 2010-04-01 2010-04-01 false Current good manufacturing practice. 123.5 Section...) FOOD FOR HUMAN CONSUMPTION FISH AND FISHERY PRODUCTS General Provisions § 123.5 Current good manufacturing practice. (a) Part 110 of this chapter applies in determining whether the facilities, methods...

  7. 21 CFR 210.1 - Status of current good manufacturing practice regulations.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Status of current good manufacturing practice... SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL § 210.1 Status of current good manufacturing practice regulations...

  8. 21 CFR 114.5 - Current good manufacturing practice.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 2 2010-04-01 2010-04-01 false Current good manufacturing practice. 114.5 Section...) FOOD FOR HUMAN CONSUMPTION ACIDIFIED FOODS General Provisions § 114.5 Current good manufacturing practice. The criteria in §§ 114.10, 114.80, 114.83, 114.89, and 114.100, as well as the criteria in part...

  9. 21 CFR 225.1 - Current good manufacturing practice.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... Current good manufacturing practice. (a) Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act... the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or...

  10. 21 CFR 225.1 - Current good manufacturing practice.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... Current good manufacturing practice. (a) Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act... the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or...

  11. 21 CFR 225.1 - Current good manufacturing practice.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... Current good manufacturing practice. (a) Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act... the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or...

  12. 21 CFR 225.1 - Current good manufacturing practice.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... Current good manufacturing practice. (a) Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act... the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or...

  13. 21 CFR 210.2 - Applicability of current good manufacturing practice regulations.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Applicability of current good manufacturing practice regulations. 210.2 Section 210.2 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING...

  14. 21 CFR 210.2 - Applicability of current good manufacturing practice regulations.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Applicability of current good manufacturing... AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL § 210.2 Applicability of current good manufacturing...

  15. 21 CFR 212.2 - What is current good manufacturing practice for PET drugs?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 4 2010-04-01 2010-04-01 false What is current good manufacturing practice for... HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR POSITRON EMISSION TOMOGRAPHY DRUGS (Eff. 12-12-2011) General Provisions § 212.2 What is current good manufacturing practice for...

  16. 78 FR 12068 - Device Good Manufacturing Practice Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-21

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Device Good Manufacturing Practice Advisory Committee; Notice of Meeting AGENCY: Food and Drug... Committee: Device Good Manufacturing Practice Advisory Committee. General Function of the Committee: To...

  17. The confusion in complying with good manufacturing practice requirements in Malaysia

    NASA Astrophysics Data System (ADS)

    Jali, Mohd Bakri; Ghani, Maaruf Abdul; Nor, Norazmir Md

    2016-11-01

    Food manufacturing operations need to fulfil regulatory requirements related to hygiene and good manufacturing practices (GMP) to successfully market their products as safe and quality products. GMP based on its ten elements used as guidelines to ensure control over biological, chemical and physical hazards. This study aims to investigate the confusion for design and facilities elements among food industries. Both qualitative and quantitative techniques are used as systematic tools. Design and facilities elements lay a firm foundation for good manufacturing practice to ensure food hygiene and should be used in conjunction with each specific code of hygiene practice and guidelines.

  18. 21 CFR 212.2 - What is current good manufacturing practice for PET drugs?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 4 2011-04-01 2011-04-01 false What is current good manufacturing practice for PET drugs? 212.2 Section 212.2 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR POSITRON EMISSION...

  19. 21 CFR 113.5 - Current good manufacturing practice.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 2 2011-04-01 2011-04-01 false Current good manufacturing practice. 113.5 Section 113.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED...

  20. 21 CFR 113.5 - Current good manufacturing practice.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 2 2013-04-01 2013-04-01 false Current good manufacturing practice. 113.5 Section 113.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED...

  1. 21 CFR 113.5 - Current good manufacturing practice.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 2 2012-04-01 2012-04-01 false Current good manufacturing practice. 113.5 Section 113.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED...

  2. 21 CFR 113.5 - Current good manufacturing practice.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 2 2014-04-01 2014-04-01 false Current good manufacturing practice. 113.5 Section 113.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED...

  3. 21 CFR 129.1 - Current good manufacturing practice.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... drinking water are in conformance with or are operated or administered in conformity with good manufacturing practice to assure that bottled drinking water is safe and that it has been processed, bottled...) FOOD FOR HUMAN CONSUMPTION PROCESSING AND BOTTLING OF BOTTLED DRINKING WATER General Provisions § 129.1...

  4. 21 CFR 120.5 - Current good manufacturing practice.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 2 2010-04-01 2010-04-01 false Current good manufacturing practice. 120.5 Section 120.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS General...

  5. 21 CFR 120.5 - Current good manufacturing practice.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 2 2013-04-01 2013-04-01 false Current good manufacturing practice. 120.5 Section 120.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS General...

  6. 21 CFR 120.5 - Current good manufacturing practice.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 2 2012-04-01 2012-04-01 false Current good manufacturing practice. 120.5 Section 120.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS General...

  7. 21 CFR 120.5 - Current good manufacturing practice.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 2 2011-04-01 2011-04-01 false Current good manufacturing practice. 120.5 Section 120.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS General...

  8. 21 CFR 120.5 - Current good manufacturing practice.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 2 2014-04-01 2014-04-01 false Current good manufacturing practice. 120.5 Section 120.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS General...

  9. Importance and globalization status of good manufacturing practice (GMP) requirements for pharmaceutical excipients

    PubMed Central

    Abdellah, Abubaker; Noordin, Mohamed Ibrahim; Wan Ismail, Wan Azman

    2013-01-01

    Pharmaceutical excipients are no longer inert materials but it is effective and able to improve the characteristics of the products’ quality, stability, functionality, safety, solubility and acceptance of patients. It can interact with the active ingredients and alter the medicament characteristics. The globalization of medicines’ supply enhances the importance of globalized good manufacturing practice (GMP) requirements for pharmaceutical excipients. This review was intended to assess the globalization status of good manufacturing practice (GMP) requirements for pharmaceutical excipients. The review outcomes demonstrate that there is a lack of accurately defined methods to evaluate and measure excipients’ safety. Furthermore good manufacturing practice requirements for excipients are not effectively globalized. PMID:25685037

  10. 21 CFR 212.2 - What is current good manufacturing practice for PET drugs?

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... PET drugs? 212.2 Section 212.2 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND... TOMOGRAPHY DRUGS General Provisions § 212.2 What is current good manufacturing practice for PET drugs? Current good manufacturing practice for PET drugs is the minimum requirements for the methods to be used...

  11. 21 CFR 212.2 - What is current good manufacturing practice for PET drugs?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... PET drugs? 212.2 Section 212.2 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND... TOMOGRAPHY DRUGS General Provisions § 212.2 What is current good manufacturing practice for PET drugs? Current good manufacturing practice for PET drugs is the minimum requirements for the methods to be used...

  12. 21 CFR 212.2 - What is current good manufacturing practice for PET drugs?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... PET drugs? 212.2 Section 212.2 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND... TOMOGRAPHY DRUGS General Provisions § 212.2 What is current good manufacturing practice for PET drugs? Current good manufacturing practice for PET drugs is the minimum requirements for the methods to be used...

  13. 76 FR 47593 - Guidance for Small Business Entities on Current Good Manufacturing Practice for Positron Emission...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-05

    ...] Guidance for Small Business Entities on Current Good Manufacturing Practice for Positron Emission... entitled ``PET Drugs--Current Good Manufacturing Practice (CGMP); Small Entity Compliance Guide.'' FDA has... consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the Agency...

  14. Good manufacturing practices for medicinal products for human use.

    PubMed

    Gouveia, Bruno G; Rijo, Patrícia; Gonçalo, Tânia S; Reis, Catarina P

    2015-01-01

    At international and national levels, there are public and private organizations, institutions and regulatory authorities, who work and cooperate between them and with Pharmaceutical Industry, in order to achieve a consensus of the guidelines and laws of the manufacturing of medicinal products for human use. This article includes an explanation of how operate and cooperate these participants, between them and expose the current regulations, following the line of European Community/European Economic Area, referencing, wherever appropriate, the practiced guidelines, outside of regulatory action of space mentioned. In this way, it is intended to achieve quality, security and effectiveness exceptional levels in the manufacturing of health products. Good Manufacturing Practice aim the promotion of the human health and consequently, to the improvement of quality of life. For achieve the proposed objectives, it is necessary to ensure the applicability of the presented concepts and show the benefits arising from this applicability.

  15. Good manufacturing practices for medicinal products for human use

    PubMed Central

    Gouveia, Bruno G.; Rijo, Patrícia; Gonçalo, Tânia S.; Reis, Catarina P.

    2015-01-01

    At international and national levels, there are public and private organizations, institutions and regulatory authorities, who work and cooperate between them and with Pharmaceutical Industry, in order to achieve a consensus of the guidelines and laws of the manufacturing of medicinal products for human use. This article includes an explanation of how operate and cooperate these participants, between them and expose the current regulations, following the line of European Community/European Economic Area, referencing, wherever appropriate, the practiced guidelines, outside of regulatory action of space mentioned. In this way, it is intended to achieve quality, security and effectiveness exceptional levels in the manufacturing of health products. Good Manufacturing Practice aim the promotion of the human health and consequently, to the improvement of quality of life. For achieve the proposed objectives, it is necessary to ensure the applicability of the presented concepts and show the benefits arising from this applicability. PMID:25883511

  16. Specificity of Good Manufacturing Practice (GMP) for Biomedical Cell Products.

    PubMed

    Tulina, M A; Pyatigorskaya, N V

    2018-03-01

    The article describes special aspects of Good Manufacturing Practice (GMP) for biomedical cell products (BMCP) that imply high standards of aseptics throughout the entire productio process, strict requirements to donors and to the procedure of biomaterial isolation, guaranty of tracing BMCP products, defining processing procedures which allow to identify BMCP as minimally manipulated; continuous quality control and automation of the control process at all stages of manufacturing, which will ensure product release simultaneously with completion of technological operations.

  17. Good manufacturing practice and viral safety.

    PubMed

    Kerner, B

    1995-07-01

    The concept of virus inactivation during the manufacture of blood products raises questions about possible recontamination of the product by the environment. A strict regime of good manufacturing practice (GMP) is mandatory. The guidelines originally issued by the World Health Organization (WHO), and now law in most countries, are an excellent basis for the operation of a production plant. The following elements of GMP require special concern: (i) All functions shall be defined in a clear organization chart. (ii) Personnel shall be appropriately trained for the job and to perfect hygiene. (iii) Buildings and facilities, as well as supply systems, shall exclude the possibility of recontamination of already virus-inactivated materials. (iv) Equipment shall be easy to clean and fully sterilizable. (v) Production shall follow appropriate written procedures. (vi) The Quality Control Organization shall monitor the process by in-process controls and review the records for possible deviations. All GMP issues are coordinated by a Quality Assurance Organization that also reviews the overall performance of the operation. The maintenance of viral safety of the products basically depends upon the full commitment of all bodies involved to proper and non-negotiable GMP.

  18. Current good manufacturing practice in manufacturing, packaging, labeling, or holding operations for dietary supplements. Final rule.

    PubMed

    2007-06-25

    The Food and Drug Administration (FDA) is issuing a final rule regarding current good manufacturing practice (CGMP) for dietary supplements. The final rule establishes the minimum CGMPs necessary for activities related to manufacturing, packaging, labeling, or holding dietary supplements to ensure the quality of the dietary supplement. The final rule is one of many actions related to dietary supplements that we are taking to promote and protect the public health.

  19. Good Manufacturing Practices (GMP) / Good Laboratory Practices (GLP) Review and Applicability for Chemical Security Enhancements

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Iveson, Steven W.

    Global chemical security has been enhanced through the determined use and integration of both voluntary and legislated standards. Many popular standards contain components that specifically detail requirements for the security of materials, facilities and other vital assets. In this document we examine the roll of quality management standards and how they affect the security culture within the institutions that adopt these standards in order to conduct business within the international market place. Good manufacturing practices and good laboratory practices are two of a number of quality management systems that have been adopted as law in many nations. These standards aremore » designed to protect the quality of drugs, medicines, foods and analytical test results in order to provide the world-wide consumer with safe and affective products for consumption. These standards provide no established security protocols and yet manage to increase the security of chemicals, materials, facilities and the supply chain via the effective and complete control over the manufacturing, the global supply chains and testing processes. We discuss the means through which these systems enhance security and how nations can further improve these systems with additional regulations that deal specifically with security in the realm of these management systems. We conclude with a discussion of new technologies that may cause disruption within the industries covered by these standards and how these issues might be addressed in order to maintain or increase the level of security within the industries and nations that have adopted these standards.« less

  20. Regulatory requirements in the good manufacturing practice production of an epithelial cell graft for ocular surface reconstruction.

    PubMed

    Sheth-Shah, Radhika; Vernon, Amanda J; Seetharaman, Shankar; Neale, Michael H; Daniels, Julie T

    2016-04-01

    In the past decade, stem cell therapy has been increasingly employed for the treatment of various diseases. Subsequently, there has been a great interest in the manufacture of stem cells under good manufacturing practice, which is required by law for their use in humans. The cells for sight Stem Cell Therapy Research Unit, based at UCL Institute of Ophthalmology, delivers somatic cell-based and tissue-engineered therapies to patients suffering from blinding eye diseases at Moorfields Eye Hospital (London, UK). The following article is based on our experience in the conception, design, construction, validation and manufacturing within a good manufacturing practice manufacturing facility based in the UK. As such the regulations can be extrapolated to the 28 members stated within the EU. However, the principles may have a broad relevance outside the EU.

  1. Media fill for validation of a good manufacturing practice-compliant cell production process.

    PubMed

    Serra, Marta; Roseti, Livia; Bassi, Alessandra

    2015-01-01

    According to the European Regulation EC 1394/2007, the clinical use of Advanced Therapy Medicinal Products, such as Human Bone Marrow Mesenchymal Stem Cells expanded for the regeneration of bone tissue or Chondrocytes for Autologous Implantation, requires the development of a process in compliance with the Good Manufacturing Practices. The Media Fill test, consisting of a simulation of the expansion process by using a microbial growth medium instead of the cells, is considered one of the most effective ways to validate a cell production process. Such simulation, in fact, allows to identify any weakness in production that can lead to microbiological contamination of the final cell product as well as qualifying operators. Here, we report the critical aspects concerning the design of a Media Fill test to be used as a tool for the further validation of the sterility of a cell-based Good Manufacturing Practice-compliant production process.

  2. [Pharmaceutical product quality control and good manufacturing practices].

    PubMed

    Hiyama, Yukio

    2010-01-01

    This report describes the roles of Good Manufacturing Practices (GMP) in pharmaceutical product quality control. There are three keys to pharmaceutical product quality control. They are specifications, thorough product characterization during development, and adherence to GMP as the ICH Q6A guideline on specifications provides the most important principles in its background section. Impacts of the revised Pharmaceutical Affairs Law (rPAL) which became effective in 2005 on product quality control are discussed. Progress of ICH discussion for Pharmaceutical Development (Q8), Quality Risk Management (Q9) and Pharmaceutical Quality System (Q10) are reviewed. In order to reconstruct GMP guidelines and GMP inspection system in the regulatory agencies under the new paradigm by rPAL and the ICH, a series of Health Science studies were conducted. For GMP guidelines, product GMP guideline, technology transfer guideline, laboratory control guideline and change control system guideline were written. For the GMP inspection system, inspection check list, inspection memo and inspection scenario were proposed also by the Health Science study groups. Because pharmaceutical products and their raw materials are manufactured and distributed internationally, collaborations with other national authorities are highly desired. In order to enhance the international collaborations, consistent establishment of GMP inspection quality system throughout Japan will be essential.

  3. Manufacture of Third-Generation Lentivirus for Preclinical Use, with Process Development Considerations for Translation to Good Manufacturing Practice.

    PubMed

    Gándara, Carolina; Affleck, Valerie; Stoll, Elizabeth Ann

    2018-02-01

    Lentiviral vectors are used in laboratories around the world for in vivo and ex vivo delivery of gene therapies, and increasingly clinical investigation as well as preclinical applications. The third-generation lentiviral vector system has many advantages, including high packaging capacity, stable gene expression in both dividing and post-mitotic cells, and low immunogenicity in the recipient organism. Yet, the manufacture of these vectors is challenging, especially at high titers required for direct use in vivo, and further challenges are presented by the process of translating preclinical gene therapies toward manufacture of products for clinical investigation. The goals of this paper are to report the protocol for manufacturing high-titer third-generation lentivirus for preclinical testing and to provide detailed information on considerations for translating preclinical viral vector manufacture toward scaled-up platforms and processes in order to make gene therapies under Good Manufacturing Practice that are suitable for clinical trials.

  4. Manufacture of Third-Generation Lentivirus for Preclinical Use, with Process Development Considerations for Translation to Good Manufacturing Practice

    PubMed Central

    Gándara, Carolina; Affleck, Valerie; Stoll, Elizabeth Ann

    2018-01-01

    Lentiviral vectors are used in laboratories around the world for in vivo and ex vivo delivery of gene therapies, and increasingly clinical investigation as well as preclinical applications. The third-generation lentiviral vector system has many advantages, including high packaging capacity, stable gene expression in both dividing and post-mitotic cells, and low immunogenicity in the recipient organism. Yet, the manufacture of these vectors is challenging, especially at high titers required for direct use in vivo, and further challenges are presented by the process of translating preclinical gene therapies toward manufacture of products for clinical investigation. The goals of this paper are to report the protocol for manufacturing high-titer third-generation lentivirus for preclinical testing and to provide detailed information on considerations for translating preclinical viral vector manufacture toward scaled-up platforms and processes in order to make gene therapies under Good Manufacturing Practice that are suitable for clinical trials. PMID:29212357

  5. Current good manufacturing practice in manufacturing, processing, packing, or holding of drugs; revision of certain labeling controls--FDA. Final rule.

    PubMed

    1993-08-03

    The Food and Drug Administration (FDA) is amending the current good manufacturing practice (CGMP) regulations for human and veterinary drug products to revise certain labeling control provisions. Specifically, the final rule defines the term "gang-printed labeling," specifies conditions for the use of gang-printed or cut labeling, exempts manufacturers that employ automated 100-percent labeling inspection systems from CGMP labeling reconciliation requirements, and requires manufacturers to identify filled drug product containers that are set aside and held in an unlabeled condition for future labeling operations. These changes are intended to reduce the frequency of drug product mislabeling and associated drug product recalls.

  6. Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements. Final rule.

    PubMed

    2016-11-18

    The Food and Drug Administration (FDA or the Agency) is amending its current good manufacturing practice (CGMP) and labeling regulations regarding medical gases. FDA is requiring that portable cryogenic medical gas containers not manufactured with permanent gas use outlet connections have gas-specific use outlet connections that cannot be readily removed or replaced except by the manufacturer. FDA is also requiring that portable cryogenic medical gas containers and high-pressure medical gas cylinders meet certain labeling, naming, and color requirements. These requirements are intended to increase the likelihood that the contents of medical gas containers are accurately identified and reduce the likelihood of the wrong gas being connected to a gas supply system or container. FDA is also revising an existing regulation that conditionally exempts certain medical gases from certain otherwise-applicable labeling requirements in order to add oxygen and nitrogen to the list of gases subject to the exemption, and to remove cyclopropane and ethylene from the list.

  7. 78 FR 64425 - Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-29

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 16, 225, 500, 507, and 579 [Docket No. FDA-2011-N-0922] Current Good Manufacturing Practice and Hazard Analysis and Risk- Based Preventive Controls for Food for Animals; Public Meeting on Proposed Rule AGENCY: Food and...

  8. Good manufacturing practice (GMP) compliance in the biologics sector: plasma fractionation.

    PubMed

    Ways, J P; Preston, M S; Baker, D; Huxsoll, J; Bablak, J

    1999-12-01

    The U.S. blood supply is the safest it has ever been. Due to blood safety and the introduction of viral inactivation/clearance technologies, protein therapies derived from human blood have also in recent years had a history of product safety. Nevertheless, since 1995, the plasma-fractionation industry has experienced increased compliance-related actions by the Food and Drug Administration (FDA), as shown by a substantive increase in the number of FDA 483 inspectional observations, FDA warning letters and other FDA regulatory action. An evaluation of these trends shows that they reflect the implementation by the FDA of increased inspectional interest in the plasma-fractionation industry and an evolution of inspectional practices and standards of current good manufacturing practice (cGMP). Plasma fractionators have responded to FDA actions by carefully evaluating and addressing each inspectional observation, assessing impact to product and taking appropriate actions, including corrective actions to prevent future occurrence. They have made major investments in facilities, quality systems, personnel and training to meet the evolving standards of cGMP and in an effort to implement these standards systemically. Through industry associations, manufacturers have further enhanced product safety by adopting additional voluntary standards for plasma to prevent the entry of potentially unsuitable plasma into the production process. The industry remains committed to application of cGMP and to working with the FDA in further evolution of these standards while striving to assure a continued supply of safe, pure and effective plasma-derived therapies.

  9. Good manufacturing practices production of a purification-free oral cholera vaccine expressed in transgenic rice plants.

    PubMed

    Kashima, Koji; Yuki, Yoshikazu; Mejima, Mio; Kurokawa, Shiho; Suzuki, Yuji; Minakawa, Satomi; Takeyama, Natsumi; Fukuyama, Yoshiko; Azegami, Tatsuhiko; Tanimoto, Takeshi; Kuroda, Masaharu; Tamura, Minoru; Gomi, Yasuyuki; Kiyono, Hiroshi

    2016-03-01

    The first Good Manufacturing Practices production of a purification-free rice-based oral cholera vaccine (MucoRice-CTB) from transgenic plants in a closed cultivation system yielded a product meeting regulatory requirements. Despite our knowledge of their advantages, plant-based vaccines remain unavailable for human use in both developing and industrialized countries. A leading, practical obstacle to their widespread use is producing plant-based vaccines that meet governmental regulatory requirements. Here, we report the first production according to current Good Manufacturing Practices of a rice-based vaccine, the cholera vaccine MucoRice-CTB, at an academic institution. To this end, we established specifications and methods for the master seed bank (MSB) of MucoRice-CTB, which was previously generated as a selection-marker-free line, evaluated its propagation, and given that the stored seeds must be renewed periodically. The production of MucoRice-CTB incorporated a closed hydroponic system for cultivating the transgenic plants, to minimize variations in expression and quality during vaccine manufacture. This type of molecular farming factory can be operated year-round, generating three harvests annually, and is cost- and production-effective. Rice was polished to a ratio of 95 % and then powdered to produce the MucoRice-CTB drug substance, and the identity, potency, and safety of the MucoRice-CTB product met pre-established release requirements. The formulation of MucoRice-CTB made by fine-powdering of drug substance and packaged in an aluminum pouch is being evaluated in a physician-initiated phase I study.

  10. Good Manufacturing Practices (GMP) manufacturing of advanced therapy medicinal products: a novel tailored model for optimizing performance and estimating costs.

    PubMed

    Abou-El-Enein, Mohamed; Römhild, Andy; Kaiser, Daniel; Beier, Carola; Bauer, Gerhard; Volk, Hans-Dieter; Reinke, Petra

    2013-03-01

    Advanced therapy medicinal products (ATMP) have gained considerable attention in academia due to their therapeutic potential. Good Manufacturing Practice (GMP) principles ensure the quality and sterility of manufacturing these products. We developed a model for estimating the manufacturing costs of cell therapy products and optimizing the performance of academic GMP-facilities. The "Clean-Room Technology Assessment Technique" (CTAT) was tested prospectively in the GMP facility of BCRT, Berlin, Germany, then retrospectively in the GMP facility of the University of California-Davis, California, USA. CTAT is a two-level model: level one identifies operational (core) processes and measures their fixed costs; level two identifies production (supporting) processes and measures their variable costs. The model comprises several tools to measure and optimize performance of these processes. Manufacturing costs were itemized using adjusted micro-costing system. CTAT identified GMP activities with strong correlation to the manufacturing process of cell-based products. Building best practice standards allowed for performance improvement and elimination of human errors. The model also demonstrated the unidirectional dependencies that may exist among the core GMP activities. When compared to traditional business models, the CTAT assessment resulted in a more accurate allocation of annual expenses. The estimated expenses were used to set a fee structure for both GMP facilities. A mathematical equation was also developed to provide the final product cost. CTAT can be a useful tool in estimating accurate costs for the ATMPs manufactured in an optimized GMP process. These estimates are useful when analyzing the cost-effectiveness of these novel interventions. Copyright © 2013 International Society for Cellular Therapy. Published by Elsevier Inc. All rights reserved.

  11. Survival and engraftment of dopaminergic neurons manufactured by a Good Manufacturing Practice-compatible process.

    PubMed

    Peng, Jun; Liu, Qiuyue; Rao, Mahendra S; Zeng, Xianmin

    2014-09-01

    We have previously reported a Good Manufacturing Practice (GMP)-compatible process for generating authentic dopaminergic neurons in defined media from human pluripotent stem cells and determined the time point at which dopaminergic precursors/neurons (day 14 after neuronal stem cell [NSC] stage) can be frozen, shipped and thawed without compromising their viability and ability to mature in vitro. One important issue we wished to address is whether dopaminergic precursors/neurons manufactured by our GMP-compatible process can be cryopreserved and engrafted in animal Parkinson disease (PD) models. In this study, we evaluated the efficacy of freshly prepared and cryopreserved dopaminergic neurons in the 6-hydroxydopamine-lesioned rat PD model. We showed functional recovery up to 6 months post-transplantation in rats transplanted with our cells, whether freshly prepared or cryopreserved. In contrast, no motor improvement was observed in two control groups receiving either medium or cells at a slightly earlier stage (day 10 after NSC stage). Histologic analysis at the end point of the study (6 months post-transplantation) showed robust long-term survival of donor-derived tyrosine hydroxylase (TH)(+) dopaminergic neurons in rats transplanted with day 14 dopaminergic neurons. Moreover, TH(+) fibers emanated from the graft core into the surrounding host striatum. Consistent with the behavioral analysis, no or few TH(+) neurons were detected in animals receiving day 10 cells, although human cells were present in the graft. Importantly, no tumors were detected in any grafted rats, but long-term tumorigenic studies will need to determine the safety of our products. Dopaminergic neurons manufactured by a GMP-compatible process from human ESC survived and engrafted efficiently in the 6-OHDA PD rat model. Copyright © 2014 International Society for Cellular Therapy. Published by Elsevier Inc. All rights reserved.

  12. 21 CFR 4.4 - How can I comply with these current good manufacturing practice requirements for a co-packaged or...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... practice operating system in accordance with paragraph (b) of this section, the following requirements..., and the current good manufacturing practice operating system has been shown to comply with the drug... operating system has been shown to comply with the QS regulation, the following provisions of the drug CGMPs...

  13. 21 CFR 4.4 - How can I comply with these current good manufacturing practice requirements for a co-packaged or...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... practice operating system in accordance with paragraph (b) of this section, the following requirements..., and the current good manufacturing practice operating system has been shown to comply with the drug... operating system has been shown to comply with the QS regulation, the following provisions of the drug CGMPs...

  14. Influence of manufacturing practices on quality of pharmaceutical products manufactured in Kenya.

    PubMed

    Orwa, J A; Keter, L K; Ouko, S P A; Kibwage, I O; Rukunga, G M

    2004-06-01

    To establish the quality of pharmaceutical products manufactured by the respective industries in Kenya and determine the effect of manufacturing practices on the quality of these products. Cross-sectional study. Industries examined are in Nairobi, Kenya. Laboratory analysis was carried out using available facilities at Kenya Medical Research Institute and University of Nairobi, Faculty of Pharmacy. Structured Questionnaires were administered to examine how the code of good manufacturing practices has been used in the production of each pharmaceutical product by respective companies. Questionnaires designed to evaluate the distribution and carry out limited post-market surveillance study were administered to community pharmacy outlets. Drugs were sampled and analyzed for their quality according to the respective monographs. The questionnaires administered to the industry included the source of raw materials, quarantine procedure before and after manufacture, manufacturing procedure, quality audit, quality assurance procedure, equipment, and staff. That administered to the pharmacy outlet included availability, affordability and acceptability of locally manufactured pharmaceutical products. Quality analysis of products involved the establishment of the chemical content, dissolution profile, friability, uniformity of weight and identity. For antibiotic suspensions the stability after reconstitution was also determined. There were 15 respondents and two non-respondents from the industry and six out of nine respondents from the pharmacy outlets. The ratio of qualified staff to product range produced seemed to influence product quality. Industries producing several products with only limited number of pharmaceutical staff had more products failing to comply with pharmacopoeia specifications compared to those producing only few products. Nevertheless, all companies are well equipped with quality control equipment, in accordance with type of product manufactured. Private

  15. Qualification of computerized monitoring systems in a cell therapy facility compliant with the good manufacturing practices.

    PubMed

    Del Mazo-Barbara, Anna; Mirabel, Clémentine; Nieto, Valentín; Reyes, Blanca; García-López, Joan; Oliver-Vila, Irene; Vives, Joaquim

    2016-09-01

    Computerized systems (CS) are essential in the development and manufacture of cell-based medicines and must comply with good manufacturing practice, thus pushing academic developers to implement methods that are typically found within pharmaceutical industry environments. Qualitative and quantitative risk analyses were performed by Ishikawa and Failure Mode and Effects Analysis, respectively. A process for qualification of a CS that keeps track of environmental conditions was designed and executed. The simplicity of the Ishikawa analysis permitted to identify critical parameters that were subsequently quantified by Failure Mode Effects Analysis, resulting in a list of test included in the qualification protocols. The approach presented here contributes to simplify and streamline the qualification of CS in compliance with pharmaceutical quality standards.

  16. Current good manufacturing practice in manufacturing, processing, packing, or holding of drugs; revision of certain labeling controls. Final rule.

    PubMed

    2012-03-20

    The Food and Drug Administration (FDA) is amending the packaging and labeling control provisions of the current good manufacturing practice (CGMP) regulations for human and veterinary drug products by limiting the application of special control procedures for the use of cut labeling to immediate container labels, individual unit cartons, or multiunit cartons containing immediate containers that are not packaged in individual unit cartons. FDA is also permitting the use of any automated technique, including differentiation by labeling size and shape, that physically prevents incorrect labeling from being processed by labeling and packaging equipment when cut labeling is used. This action is intended to protect consumers from labeling errors more likely to cause adverse health consequences, while eliminating the regulatory burden of applying the rule to labeling unlikely to reach or adversely affect consumers. This action is also intended to permit manufacturers to use a broader range of error prevention and labeling control techniques than permitted by current CGMPs.

  17. Current good manufacturing practice and investigational new drugs intended for use in clinical trials. Final rule.

    PubMed

    2008-07-15

    The Food and Drug Administration (FDA) is amending the current good manufacturing practice (CGMP) regulations for human drugs, including biological products, to exempt most phase 1 investigational drugs from complying with the regulatory CGMP requirements. FDA will continue to exercise oversight of the manufacture of these drugs under FDA's general statutory CGMP authority and through review of the investigational new drug applications (IND). In addition, elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document entitled "Guidance for Industry: CGMP for Phase 1 Investigational Drugs" dated November 2007 (the companion guidance). This guidance document sets forth recommendations on approaches to compliance with statutory CGMP for the exempted phase 1 investigational drugs. FDA is taking this action to focus a manufacturer's effort on applying CGMP that is appropriate and meaningful for the manufacture of the earliest stage investigational drug products intended for use in phase 1 clinical trials while ensuring safety and quality. This action will also streamline and promote the drug development process.

  18. 78 FR 16824 - Tobacco Product Manufacturing Practice; Establishment of a Public Docket

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-19

    ... recommendations for regulations on good manufacturing practice for tobacco products that were submitted to FDA by... performance of a tobacco product), packing, and storage of a tobacco product conform to current good... group of 13 tobacco companies submitted to FDA: (1) Recommendations for good manufacturing practice...

  19. 78 FR 64735 - Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-29

    ...The Food and Drug Administration (FDA) is proposing regulations for domestic and foreign facilities that are required to register under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to establish requirements for current good manufacturing practice in manufacturing, processing, packing, and holding of animal food. FDA also is proposing regulations to require that certain facilities establish and implement hazard analysis and risk-based preventive controls for food for animals. FDA is taking this action to provide greater assurance that animal food is safe and will not cause illness or injury to animals or humans and is intended to build an animal food safety system for the future that makes modern, science and risk-based preventive controls the norm across all sectors of the animal food system.

  20. 78 FR 24691 - Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-26

    ... Manufacturing Practice and Hazard Analysis and Risk- Based Preventive Controls for Human Food; Extension of... Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food'' that appeared in... Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food'' with a 120-day...

  1. Safety Profile of Good Manufacturing Practice Manufactured Interferon γ-Primed Mesenchymal Stem/Stromal Cells for Clinical Trials.

    PubMed

    Guess, Adam J; Daneault, Beth; Wang, Rongzhang; Bradbury, Hillary; La Perle, Krista M D; Fitch, James; Hedrick, Sheri L; Hamelberg, Elizabeth; Astbury, Caroline; White, Peter; Overolt, Kathleen; Rangarajan, Hemalatha; Abu-Arja, Rolla; Devine, Steven M; Otsuru, Satoru; Dominici, Massimo; O'Donnell, Lynn; Horwitz, Edwin M

    2017-10-01

    Mesenchymal stem/stromal cells (MSCs) are widely studied by both academia and industry for a broad array of clinical indications. The collective body of data provides compelling evidence of the clinical safety of MSC therapy. However, generally accepted proof of therapeutic efficacy has not yet been reported. In an effort to generate a more effective therapeutic cell product, investigators are focused on modifying MSC processing protocols to enhance the intrinsic biologic activity. Here, we report a Good Manufacturing Practice-compliant two-step MSC manufacturing protocol to generate MSCs or interferon γ (IFNγ) primed MSCs which allows freshly expanded cells to be infused in patients on a predetermined schedule. This protocol eliminates the need to infuse cryopreserved, just thawed cells which may reduce the immune modulatory activity. Moreover, using (IFNγ) as a prototypic cytokine, we demonstrate the feasibility of priming the cells with any biologic agent. We then characterized MSCs and IFNγ primed MSCs prepared with our protocol, by karyotype, in vitro potential for malignant transformation, biodistribution, effect on engraftment of transplanted hematopoietic cells, and in vivo toxicity in immune deficient mice including a complete post-mortem examination. We found no evidence of toxicity attributable to the MSC or IFNγ primed MSCs. Our data suggest that the clinical risk of infusing MSCs or IFNγ primed MSCs produced by our two-step protocol is not greater than MSCs currently in practice. While actual proof of safety requires phase I clinical trials, our data support the use of either cell product in new clinical studies. Stem Cells Translational Medicine 2017;6:1868-1879. © 2017 The Authors Stem Cells Translational Medicine published by Wiley Periodicals, Inc. on behalf of AlphaMed Press.

  2. 78 FR 69604 - Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-20

    ... Manufacturing Practice and Hazard Analysis and Risk- Based Preventive Controls for Human Food; Extension of... Hazard Analysis and Risk- Based Preventive Controls for Human Food'' and its information collection... Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food.'' IV. How To...

  3. Inactivated human platelet lysate with psoralen: a new perspective for mesenchymal stromal cell production in Good Manufacturing Practice conditions.

    PubMed

    Castiglia, Sara; Mareschi, Katia; Labanca, Luciana; Lucania, Graziella; Leone, Marco; Sanavio, Fiorella; Castello, Laura; Rustichelli, Deborah; Signorino, Elena; Gunetti, Monica; Bergallo, Massimiliano; Bordiga, Anna Maria; Ferrero, Ivana; Fagioli, Franca

    2014-06-01

    Mesenchymal stromal cells (MSC) are ideal candidates for regenerative and immunomodulatory therapies. The use of xenogeneic protein-free Good Manufacturing Practice-compliant growth media is a prerequisite for clinical MSC isolation and expansion. Human platelet lysate (HPL) has been efficiently implemented into MSC clinical manufacturing as a substitute for fetal bovine serum (FBS). Because the use of human-derived blood materials alleviates immunologic risks but not the transmission of blood-borne viruses, the aim of our study was to test an even safer alternative than HPL to FBS: HPL subjected to pathogen inactivation by psoralen (iHPL). Bone marrow samples were plated and expanded in α-minimum essential medium with 10% of three culture supplements: HPL, iHPL and FBS, at the same time. MSC morphology, growth and immunophenotype were analyzed at each passage. Karyotype, tumorigenicity and sterility were analyzed at the third passage. Statistical analyses were performed. The MSCs cultivated in the three different culture conditions showed no significant differences in terms of fibroblast colony-forming unit number, immunophenotype or in their multipotent capacity. Conversely, the HPL/iHPL-MSCs were smaller, more numerous, had a higher proliferative potential and showed a higher Oct-3/4 and NANOG protein expression than did FBS-MSCs. Although HPL/iHPL-MSCs exhibit characteristics that may be attributable to a higher primitive stemness than FBS-MSCs, no tumorigenic mutations or karyotype modifications were observed. We demonstrated that iHPL is safer than HPL and represents a good, Good Manufacturing Practice-compliant alternative to FBS for MSC clinical production that is even more advantageous in terms of cellular growth and stemness. Copyright © 2014 International Society for Cellular Therapy. Published by Elsevier Inc. All rights reserved.

  4. From skin biopsy to neurons through a pluripotent intermediate under Good Manufacturing Practice protocols.

    PubMed

    Karumbayaram, Saravanan; Lee, Peiyee; Azghadi, Soheila F; Cooper, Aaron R; Patterson, Michaela; Kohn, Donald B; Pyle, April; Clark, Amander; Byrne, James; Zack, Jerome A; Plath, Kathrin; Lowry, William E

    2012-01-01

    The clinical application of human-induced pluripotent stem cells (hiPSCs) requires not only the production of Good Manufacturing Practice-grade (GMP-grade) hiPSCs but also the derivation of specified cell types for transplantation under GMP conditions. Previous reports have suggested that hiPSCs can be produced in the absence of animal-derived reagents (xenobiotics) to ease the transition to production under GMP standards. However, to facilitate the use of hiPSCs in cell-based therapeutics, their progeny should be produced not only in the absence of xenobiotics but also under GMP conditions requiring extensive standardization of protocols, documentation, and reproducibility of methods and product. Here, we present a successful framework to produce GMP-grade derivatives of hiPSCs that are free of xenobiotic exposure from the collection of patient fibroblasts, through reprogramming, maintenance of hiPSCs, identification of reprogramming vector integration sites (nrLAM-PCR), and finally specification and terminal differentiation of clinically relevant cells. Furthermore, we developed a primary set of Standard Operating Procedures for the GMP-grade derivation and differentiation of these cells as a resource to facilitate widespread adoption of these practices.

  5. Current good manufacturing practice regulation and investigational new drugs. Direct final rule.

    PubMed

    2006-01-17

    The Food and Drug Administration (FDA) is amending its current good manufacturing practice (CGMP) regulations for human drugs, including biological products, to exempt most investigational "Phase 1" drugs from complying with the requirements in FDA's regulations. FDA will instead exercise oversight of production of these drugs under the agency's general statutory CGMP authority and investigational new drug application (IND) authority. In addition, FDA is making available simultaneously with the publication of this direct final rule, a guidance document setting forth recommendations on approaches to CGMP compliance for the exempted Phase 1 drugs. Elsewhere in this issue of the Federal Register, FDA is publishing a companion proposed rule, under FDA's usual procedure for notice-and-comment rulemaking, to provide a procedural framework to finalize the rule in the event the agency receives any significant adverse comments and withdraws this direct final rule. The companion proposed rule and direct final rule are substantively identical. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a draft guidance for industry entitled "INDs--Approaches to Complying With CGMP During Phase 1" to provide further guidance on the subject.

  6. 78 FR 3646 - Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-16

    ...The Food and Drug Administration (FDA) is proposing to amend its regulation for Current Good Manufacturing Practice In Manufacturing, Packing, or Holding Human Food (CGMPs) to modernize it and to add requirements for domestic and foreign facilities that are required to register under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to establish and implement hazard analysis and risk- based preventive controls for human food. FDA also is proposing to revise certain definitions in FDA's current regulation for Registration of Food Facilities to clarify the scope of the exemption from registration requirements provided by the FD&C Act for ``farms.'' FDA is taking this action as part of its announced initiative to revisit the CGMPs since they were last revised in 1986 and to implement new statutory provisions in the FD&C Act. The proposed rule is intended to build a food safety system for the future that makes modern, science-, and risk-based preventive controls the norm across all sectors of the food system.

  7. Standardization of Good Manufacturing Practice-compliant production of bone marrow-derived human mesenchymal stromal cells for immunotherapeutic applications.

    PubMed

    Wuchter, Patrick; Bieback, Karen; Schrezenmeier, Hubert; Bornhäuser, Martin; Müller, Lutz P; Bönig, Halvard; Wagner, Wolfgang; Meisel, Roland; Pavel, Petra; Tonn, Torsten; Lang, Peter; Müller, Ingo; Renner, Matthias; Malcherek, Georg; Saffrich, Rainer; Buss, Eike C; Horn, Patrick; Rojewski, Markus; Schmitt, Anita; Ho, Anthony D; Sanzenbacher, Ralf; Schmitt, Michael

    2015-02-01

    Human mesenchymal stem or stromal cells (MSCs) represent a potential resource not only for regenerative medicine but also for immunomodulatory cell therapies. The application of different MSC culture protocols has significantly hampered the comparability of experimental and clinical data from different laboratories and has posed a major obstacle for multicenter clinical trials. Manufacturing of cell products for clinical application in the European Community must be conducted in compliance with Good Manufacturing Practice and requires a manufacturing license. In Germany, the Paul-Ehrlich-Institut as the Federal Authority for Vaccines and Biomedicines is critically involved in the approval process. This report summarizes a consensus meeting between researchers, clinicians and regulatory experts on standard quality requirements for MSC production. The strategy for quality control testing depends on the product's cell composition, the manufacturing process and the indication and target patient population. Important quality criteria in this sense are, among others, the immunophenotype of the cells, composition of the culture medium and the risk for malignant transformation, as well as aging and the immunosuppressive potential of the manufactured MSCs. This position paper intends to provide relevant information to interested parties regarding these criteria to foster the development of scientifically valid and harmonized quality standards and to support approval of MSC-based investigational medicinal products. Copyright © 2015 International Society for Cellular Therapy. Published by Elsevier Inc. All rights reserved.

  8. 78 FR 17142 - Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-20

    ... Manufacturing Practice and Hazard Analysis and Risk- Based Preventive Controls for Human Food; Correction AGENCY... manufacturing, packing, or holding human food (CGMPs) to modernize it and to add requirements for domestic and... ``food-production purposes (i.e., manufacturing, processing, packing, and holding) to consistently use...

  9. The Status of Implementation of Good Manufacturing Practices (GMP) Shredded Fish Production in UMKM Az-Zahrah, Makassar

    NASA Astrophysics Data System (ADS)

    Latif, Rindam; Dirpan, Andi; Indriani, Sylvia

    2017-12-01

    Good manufacturing practices (GMP) describes the requirements that an industry should follow throughout the production process starting from sorting raw materials to handling final products. The purpose of this research is to disclose each phase of GMP in making shredded fish and to assess the status of the practices implemented by the UMKM Az-zahrah in producing its product. This descriptive study is conducted by doing interview with owner followed by observation and documentation of all activities related to the production process in order to assess the status of GMP applied by the UMKM Az-zahrah. In assessing the status, we referred to Permenperin RI No.75 / M-Ind / Per / 7/2010 and KBPOM regulation no. HK 03.1.23.04.12.22007 Year 2012. The findings indicate some deviation occurred when UMKM Az-zahrah implemented it, those are (1) there is a pet in production room (2) production employees are not yet wearing work uniform (3) production room has directly access to toilet (4) there is no health label about health and nutritional claims. The status of applied GMP in the UMKM Az-zahrah is at D level (less good) with rating IV.

  10. 76 FR 82308 - Guidance for Industry: Current Good Tissue Practice and Additional Requirements for Manufacturers...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-30

    ... Cells, Tissues, and Cellular and Tissue-Based Products; Availability AGENCY: Food and Drug... Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)'' dated... Tissue Practice (CGTP) and Additional Requirements for Manufacturers of Human Cells, Tissues, and...

  11. Petition to request an exemption from 100 percent identity testing of dietary ingredients: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements. Interim final rule.

    PubMed

    2007-06-25

    The Food and Drug Administration (FDA) is issuing an interim final rule (IFR) that sets forth a procedure for requesting an exemption from the requirement in the final rule "Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements," published elsewhere in this issue of the Federal Register, that the manufacturer conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient. This IFR allows for submission to, and review by, FDA of an alternative to the required 100 percent identity testing of components that are dietary ingredients, provided certain conditions are met and establishes a requirement for retention of records relating to the FDA's response to an exemption request.

  12. Current good manufacturing practices, quality control procedures, quality factors, notification requirements, and records and reports, for infant formula. Final rule.

    PubMed

    2014-06-10

    The Food and Drug Administration (FDA or we) is issuing a final rule that adopts, with some modifications, the interim final rule (IFR) entitled "Current Good Manufacturing Practices, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports, for Infant Formula'' (February 10, 2014). This final rule affirms the IFR's changes to FDA's regulations and provides additional modifications and clarifications. The final rule also responds to certain comments submitted in response to the request for comments in the IFR.

  13. Good cell culture practices &in vitro toxicology.

    PubMed

    Eskes, Chantra; Boström, Ann-Charlotte; Bowe, Gerhard; Coecke, Sandra; Hartung, Thomas; Hendriks, Giel; Pamies, David; Piton, Alain; Rovida, Costanza

    2017-12-01

    Good Cell Culture Practices (GCCP) is of high relevance to in vitro toxicology. The European Society of Toxicology In Vitro (ESTIV), the Center for Alternatives for Animal Testing (CAAT) and the In Vitro Toxicology Industrial Platform (IVTIP) joined forces to address by means of an ESTIV 2016 pre-congress session the different aspects and applications of GCCP. The covered aspects comprised the current status of the OECD guidance document on Good In Vitro Method Practices, the importance of quality assurance for new technological advances in in vitro toxicology including stem cells, and the optimized implementation of Good Manufacturing Practices and Good Laboratory Practices for regulatory testing purposes. General discussions raised the duality related to the difficulties in implementing GCCP in an academic innovative research framework on one hand, and on the other hand, the need for such GCCP principles in order to ensure reproducibility and robustness of in vitro test methods for toxicity testing. Indeed, if good cell culture principles are critical to take into consideration for all uses of in vitro test methods for toxicity testing, the level of application of such principles may depend on the stage of development of the test method as well as on the applications of the test methods, i.e., academic innovative research vs. regulatory standardized test method. Copyright © 2017 Elsevier Ltd. All rights reserved.

  14. Assessment of good manufacturing practice for small scale food industry in Malang region, East Java, Indonesia

    NASA Astrophysics Data System (ADS)

    Purwantiningrum, I.; Widyhastuty, W.; Christian, J.; Sari, N.

    2018-03-01

    Enhancing food safety in developing countries, such as Indonesia, poses more challenges, especially those of the small- and medium-scale. Various food safety systems are available and readily implemented in the food industry. However, to ensure the effectiveness of such systems, pre-requisite programs should be applied prior to the implementation of food safety system. One of the most acknowledged pre-requisite program is Good Manufacturing Practices (GMP). The aim of this study is to assess the GMP compliance of some small-scale food companies in East Java. Three types of traditional food product were selected, include tempe chips, palm sugar, and instant herbal drink. A survey involving three companies for each type of traditional food was conducted. Data was obtained through observation and assessment based on tabulated criteria in GMP criteria. In essential, the result revealed the compliment level of the food companies being surveyed. There was different level of compliment between each type of the food industry, where the palm sugar industry had the lowest level of compliment compared to the other two. This difference is due to the food safety awareness, social and cultural influences, and also knowledge on food safety and hygiene practice.

  15. Development and production of good manufacturing practice grade human embryonic stem cell lines as source material for clinical application.

    PubMed

    De Sousa, P A; Downie, J M; Tye, B J; Bruce, K; Dand, P; Dhanjal, S; Serhal, P; Harper, J; Turner, M; Bateman, M

    2016-09-01

    From 2006 to 2011, Roslin Cells Ltd derived 17 human embryonic stem cells (hESC) while developing (RCM1, RC-2 to -8, -10) and implementing (RC-9, -11 to -17) quality assured standards of operation in a facility operating in compliance with European Union (EU) directives and United Kingdom (UK) licensure for procurement, processing and storage of human cells as source material for clinical application, and targeted to comply with an EU Good Manufacturing Practice specification. Here we describe the evolution and specification of the facility, its operation and outputs, complementing hESC resource details communicated in Stem Cell Research Lab Resources. Copyright © 2016. Published by Elsevier B.V.

  16. 78 FR 11611 - Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-19

    ... Manufacturing Practice and Hazard Analysis and Risk- Based Preventive Controls for Human Food; Extension of... Analysis and Risk-Based Preventive Controls for Human Food.'' FOR FURTHER INFORMATION CONTACT: Domini Bean... Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food'' with a 120-day comment...

  17. Current Good Manufacturing Practice Production of an Oncolytic Recombinant Vesicular Stomatitis Viral Vector for Cancer Treatment

    PubMed Central

    Meseck, M.; Derecho, I.; Lopez, P.; Knoblauch, C.; McMahon, R.; Anderson, J.; Dunphy, N.; Quezada, V.; Khan, R.; Huang, P.; Dang, W.; Luo, M.; Hsu, D.; Woo, S.L.C.; Couture, L.

    2011-01-01

    Abstract Vesicular stomatitis virus (VSV) is an oncolytic virus currently being investigated as a promising tool to treat cancer because of its ability to selectively replicate in cancer cells. To enhance the oncolytic property of the nonpathologic laboratory strain of VSV, we generated a recombinant vector [rVSV(MΔ51)-M3] expressing murine gammaherpesvirus M3, a secreted viral chemokine-binding protein that binds to a broad range of mammalian chemokines with high affinity. As previously reported, when rVSV(MΔ51)-M3 was used in an orthotopic model of hepatocellular carcinoma (HCC) in rats, it suppressed inflammatory cell migration to the virus-infected tumor site, which allowed for enhanced intratumoral virus replication leading to increased tumor necrosis and substantially prolonged survival. These encouraging results led to the development of this vector for clinical translation in patients with HCC. However, a scalable current Good Manufacturing Practice (cGMP)-compliant manufacturing process has not been described for this vector. To produce the quantities of high-titer virus required for clinical trials, a process that is amenable to GMP manufacturing and scale-up was developed. We describe here a large-scale (50-liter) vector production process capable of achieving crude titers on the order of 109 plaque-forming units (PFU)/ml under cGMP. This process was used to generate a master virus seed stock and a clinical lot of the clinical trial agent under cGMP with an infectious viral titer of approximately 2 × 1010 PFU/ml (total yield, 1 × 1013 PFU). The lot has passed all U.S. Food and Drug Administration-mandated release testing and will be used in a phase 1 clinical translational trial in patients with advanced HCC. PMID:21083425

  18. Current good manufacturing practice production of an oncolytic recombinant vesicular stomatitis viral vector for cancer treatment.

    PubMed

    Ausubel, L J; Meseck, M; Derecho, I; Lopez, P; Knoblauch, C; McMahon, R; Anderson, J; Dunphy, N; Quezada, V; Khan, R; Huang, P; Dang, W; Luo, M; Hsu, D; Woo, S L C; Couture, L

    2011-04-01

    Vesicular stomatitis virus (VSV) is an oncolytic virus currently being investigated as a promising tool to treat cancer because of its ability to selectively replicate in cancer cells. To enhance the oncolytic property of the nonpathologic laboratory strain of VSV, we generated a recombinant vector [rVSV(MΔ51)-M3] expressing murine gammaherpesvirus M3, a secreted viral chemokine-binding protein that binds to a broad range of mammalian chemokines with high affinity. As previously reported, when rVSV(MΔ51)-M3 was used in an orthotopic model of hepatocellular carcinoma (HCC) in rats, it suppressed inflammatory cell migration to the virus-infected tumor site, which allowed for enhanced intratumoral virus replication leading to increased tumor necrosis and substantially prolonged survival. These encouraging results led to the development of this vector for clinical translation in patients with HCC. However, a scalable current Good Manufacturing Practice (cGMP)-compliant manufacturing process has not been described for this vector. To produce the quantities of high-titer virus required for clinical trials, a process that is amenable to GMP manufacturing and scale-up was developed. We describe here a large-scale (50-liter) vector production process capable of achieving crude titers on the order of 10(9) plaque-forming units (PFU)/ml under cGMP. This process was used to generate a master virus seed stock and a clinical lot of the clinical trial agent under cGMP with an infectious viral titer of approximately 2 × 10(10) PFU/ml (total yield, 1 × 10(13) PFU). The lot has passed all U.S. Food and Drug Administration-mandated release testing and will be used in a phase 1 clinical translational trial in patients with advanced HCC.

  19. Influence of good manufacturing practices on the shelf life of refrigerated fillets of tilapia (Oreochromis niloticus) packed in modified atmosphere and gamma-irradiated

    PubMed Central

    Monteiro, Maria Lúcia Guerra; Mársico, Eliane Teixeira; Mano, Sérgio Borges; Teixeira, Claudia Emília; da Cruz Silva Canto, Anna Carolina Vilhena; de Carvalho Vital, Helio; Conte-Júnior, Carlos Adam

    2013-01-01

    This study evaluated the influence of good manufacturing practices (GMP) on the shelf life of refrigerated fillets of Nile tilapia (Oreochromis niloticus) packed in modified atmosphere packaging (MAP) and irradiated. In a first series of experiments, 120 tilapia fillets kept under controlled sanitary conditions were purchased from a fish market managed by a cooperative. A second lot totaling 200 tilapia fillets was obtained under controlled storage conditions from a pilot plant. The combined effects of MAP (40% CO2 and 60% N2) and irradiation (1.5 kGy) were investigated by monitoring physical and chemical (total volatile bases and pH), bacteriological (aerobic heterotrophic mesophilic and psychrophilic bacteria) and sensory (acceptance test) changes in the samples. The quality of samples decreased with storage time regardless of the treatment, remaining higher in fillets produced in the pilot plant in comparison with the commercially produced fillets. The observed shelf life of nonirradiated commercially produced fillets was only 3 days, compared to 8 days for those produced in the pilot plant, probably due to GMP in the latter. It was concluded that, even with a combination of proven conservation methods for meats, the adoption of good manufacturing practices still remains essential before, during, and after the filleting process in order to ensure the effectiveness of the entire treatment. PMID:24804034

  20. The good laboratory practice and good clinical practice requirements for the production of radiopharmaceuticals in clinical research.

    PubMed

    De Vos, Filip J; De Decker, Mario; Dierckx, Rudi A

    2005-07-01

    Radiopharmaceuticals account for more than 95% of the group of sterile pharmaceutical products and should therefore be handled and produced with care. Since the introduction of the European directive, all pharmaceuticals used in clinical studies must be prepared under good manufacturing practice (GMP) conditions. This review aims to give an overview of the basic principles and guidelines for the preparation of radiopharmaceuticals. Special attention is given to the production area environment and personnel, the two basic requirements for GMP productions. Especially for the production area, two philosophies have to be combined: the cascade system of over-pressure for the production of pharmaceuticals and the under pressure system for the manufacturing of radioisotopes. Personnel should be selected based on education and regularly given special training for the handling of radioactive material. Compared to pharmaceuticals, radiopharmaceuticals have their own labels, taking into account their specific nature. Besides the standard quality control, other items for quality control of radiopharmaceuticals are also discussed in this article.

  1. Aid conditionalities, international Good Manufacturing Practice standards and local production rights: a case study of local production in Nepal.

    PubMed

    Brhlikova, Petra; Harper, Ian; Subedi, Madhusudan; Bhattarai, Samita; Rawal, Nabin; Pollock, Allyson M

    2015-06-14

    Local pharmaceutical production has been endorsed by the WHO as a means of addressing health priorities of developing countries. However, local producers of essential medicines must comply with international pharmaceutical standards in order to be eligible to compete in donor tenders. These standards determine production rights for on-patent and off-patent medicines, and guide international procurement of medicines. We reviewed the literature on the impact of Good Manufacturing Practice (GMP) on local production; a gap analysis from the literature review indicated a need for further research. Over sixty interviews were conducted with people involved in the Nepali pharmaceutical production and distribution chain from 2006 to 2009 on the GMP areas of relevance: regulatory capacity, staffing, funding and training, resourcing of GMP, inspectors' interpretation of the rules and compliance. Although Nepal producers have increased their overall share of the domestic market, only the public manufacturer, Royal Drugs, focuses on medicines for public health programmes; private producers engage mainly in brand competition for private markets, not essential medicines. Nepali regulators and producers state that implementation of GMP standards is hindered by low regulatory capacity, insufficient training of staff in the industry, financial constraints and lack of investment for upgrading capital. The transition period to mandatory compliance with WHO GMP rules is lengthy. Less than half of private producers had WHO GMP in 2013. Producers are not directly affected by international harmonisation of standards as they do not export medicines and the Nepali regulator does not enforce the WHO standards strictly. Without an international GMP certificate they cannot tender for donor dependent health programmes. In Nepal, local private manufacturers focus mainly on brand competition for private consumption not essential medicines, the government preferentially procures essential

  2. Good Manufacturing Practices production and analysis of a DNA vaccine against dental caries.

    PubMed

    Yang, Ya-ping; Li, Yu-hong; Zhang, Ai-hua; Bi, Lan; Fan, Ming-wen

    2009-11-01

    To prepare a clinical-grade anti-caries DNA vaccine pGJA-P/VAX and explore its immune effect and protective efficacy against a cariogenic bacterial challenge. A large-scale industrial production process was developed under Good Manufacturing Practices (GMP) by combining and optimizing common unit operations such as alkaline lysis, precipitation, endotoxin removal and column chromatography. Quality controls of the purified bulk and final lyophilized vaccine were conducted according to authoritative guidelines. Mice and gnotobiotic rats were intranasally immunized with clinical-grade pGJA-P/VAX with chitosan. Antibody levels of serum IgG and salivary SIgA were assessed by an enzyme-linked immunosorbent assay (ELISA), and caries activity was evaluated by the Keyes method. pGJA-P/VAX and pVAX1 prepared by a laboratory-scale commercial kit were used as controls. The production process proved to be scalable and reproducible. Impurities including host protein, residual RNA, genomic DNA and endotoxin in the purified plasmid were all under the limits of set specifications. Intranasal vaccination with clinical-grade pGJA-P/VAX induced higher serum IgG and salivary SIgA in both mice and gnotobiotic rats. While in the experimental caries model, the enamel (E), dentinal slight (Ds), and dentinal moderate (Dm) caries lesions were reduced by 21.1%, 33.0%, and 40.9%, respectively. The production process under GMP was efficient in preparing clinical-grade pGJA-P/VAX with high purity and intended effectiveness, thus facilitating future clinical trials for the anti-caries DNA vaccine.

  3. 40 CFR 86.1851-01 - Application of good engineering judgment to manufacturers' decisions.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 40 Protection of Environment 19 2014-07-01 2014-07-01 false Application of good engineering... of good engineering judgment to manufacturers' decisions. (a) The manufacturer shall exercise good engineering judgment in making all decisions called for under this subpart, including but not limited to...

  4. Human embryonic stem cells and good manufacturing practice: Report of a 1- day workshop held at Stem Cell Biology Research Center, Yazd, 27th April 2017.

    PubMed

    Akyash, Fatemeh; Sadeghian-Nodoushan, Fatemeh; Tahajjodi, Somayyeh Sadat; Nikukar, Habib; Farashahi Yazd, Ehsan; Azimzadeh, Mostafa; D Moore, Harry; Aflatoonian, Behrouz

    2017-05-01

    This report explains briefly the minutes of a 1-day workshop entitled; "human embryonic stem cells (hESCs) and good manufacturing practice (GMP)" held by Stem Cell Biology Research Center based in Yazd Reproductive Sciences Institute at Shahid Sadoughi University of Medical Sciences, Yazd, Iran on 27 th April 2017. In this workshop, in addition to the practical sessions, Prof. Harry D. Moore from Centre for Stem Cell Biology, University of Sheffield, UK presented the challenges and the importance of the biotechnology of clinical-grade human embryonic stem cells from first derivation to robust defined culture for therapeutic applications.

  5. 40 CFR 86.1851-01 - Application of good engineering judgment to manufacturers' decisions.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 19 2010-07-01 2010-07-01 false Application of good engineering... Application of good engineering judgment to manufacturers' decisions. (a) The manufacturer shall exercise good engineering judgment in making all decisions called for under this subpart, including but not limited to...

  6. 40 CFR 86.1851-01 - Application of good engineering judgment to manufacturers' decisions.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 40 Protection of Environment 19 2011-07-01 2011-07-01 false Application of good engineering... Application of good engineering judgment to manufacturers' decisions. (a) The manufacturer shall exercise good engineering judgment in making all decisions called for under this subpart, including but not limited to...

  7. 40 CFR 86.1851-01 - Application of good engineering judgment to manufacturers' decisions.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 40 Protection of Environment 20 2012-07-01 2012-07-01 false Application of good engineering... Application of good engineering judgment to manufacturers' decisions. (a) The manufacturer shall exercise good engineering judgment in making all decisions called for under this subpart, including but not limited to...

  8. 40 CFR 86.1851-01 - Application of good engineering judgment to manufacturers' decisions.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 40 Protection of Environment 20 2013-07-01 2013-07-01 false Application of good engineering... Application of good engineering judgment to manufacturers' decisions. (a) The manufacturer shall exercise good engineering judgment in making all decisions called for under this subpart, including but not limited to...

  9. Gram-scale production of plasmid pUDK-HGF with current good manufacturing practices for gene therapy of critical limb ischemia.

    PubMed

    Hu, ChunSheng; Cheng, XiaoChen; Lu, YuXin; Wu, ZuZe; Zhang, QingLin

    2016-11-16

    The demand of a plasmid encoding human hepatocyte growth factor gene (pUDK-HGF) in large quantities at high purity and concentration has increased for gene therapy of critical limb ischemia (CLI) in clinical trials. In this article, we produced pUDK-HGF in compliance with current good manufacturing practices at gram scale. The process included a 50-L batch fermentation, continuous alkaline lysis, and integrated three-step chromatography on Sepharose 6 Fast Flow, PlasmidSelect Xtra, and Source 15Q. The production process has been scaled up to yield 4.24 ± 0.41 g of pharmaceutical pUDK-HGF from 1.0 kg bacterial cell paste and the overall yield reached range from 58.37 to 66.70%. The final pUDK-HGF product exhibited high purity with supercoiled percentage of > 95.8% and undetectable residual RNA, contaminated protein, and bacterial endotoxin. The phase I clinical study indicates that intramuscular injection of pUDK-HGF is safe, well tolerated, and may provide symptomatic relief to CLI patients. These results show that our manufacturing process of pUDK-HGF is efficient in producing pharmaceutical-grade plasmid DNA and is safe for clinical applications.

  10. 78 FR 48636 - Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-09

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 1, 16, 106, 110... Manufacturing Practice and Hazard Analysis and Risk- Based Preventive Controls for Human Food; Extension of...-Based Preventive Controls for Human Food,'' that appeared in the Federal Register of January 16, 2013...

  11. Cloud manufacturing: from concept to practice

    NASA Astrophysics Data System (ADS)

    Ren, Lei; Zhang, Lin; Tao, Fei; Zhao, Chun; Chai, Xudong; Zhao, Xinpei

    2015-02-01

    The concept of cloud manufacturing is emerging as a new promising manufacturing paradigm, as well as a business model, which is reshaping the service-oriented, highly collaborative, knowledge-intensive and eco-efficient manufacturing industry. However, the basic concepts about cloud manufacturing are still in discussion. Both academia and industry will need to have a commonly accepted definition of cloud manufacturing, as well as further guidance and recommendations on how to develop and implement cloud manufacturing. In this paper, we review some of the research work and clarify some fundamental terminologies in this field. Further, we developed a cloud manufacturing systems which may serve as an application example. From a systematic and practical perspective, the key requirements of cloud manufacturing platforms are investigated, and then we propose a cloud manufacturing platform prototype, MfgCloud. Finally, a public cloud manufacturing system for small- and medium-sized enterprises (SME) is presented. This paper presents a new perspective for cloud manufacturing, as well as a cloud-to-ground solution. The integrated solution proposed in this paper, including the terminology, MfgCloud, and applications, can push forward this new paradigm from concept to practice.

  12. Building Skills and Qualifications among SME Employees. Leonardo da Vinci Good Practices Series.

    ERIC Educational Resources Information Center

    Commission of the European Communities, Brussels (Belgium). Directorate-General for Education and Culture.

    This document profiles 10 European programs that exemplify good practice in building skills and qualifications among employees of small and medium enterprises (SMEs). The programs profiled are as follows: (1) TRICTSME (a program providing World Wide Web-based information and communication technologies training for SMEs in manufacturing); (2)…

  13. Guidelines for Good Epidemiology Practices for Occupational and Environmental Epidemiologic Research. The Chemical Manufacturers Association's Epidemiology Task Group.

    PubMed

    1991-12-01

    The Guidelines for Good Epidemiology Practices (GEPs) for Occupational and Environmental Epidemiologic Research address the conduct of studies generally undertaken to answer questions about human health in relationship to the work place or the environment. The GEPs propose minimum practices and procedures that should be considered to help ensure the quality and integrity of data used in epidemiologic research and to provide adequate documentation of the research methods. The GEPs address the process of conducting individual epidemiologic studies and do not prescribe specific research methods. The Guidelines for Good Epidemiology Practices propose minimum practices and procedures in the following areas: I. Organization and Personnel II. Facilities, Resource Commitment, and Contractors III. Protocol IV. Review and Approval V. Study Conduct VI. Communication VII. Archiving VIII. Quality Assurance Although the Guidelines for Good Epidemiology Practices will not guarantee good epidemiology, they do provide a useful framework for ensuring that all research issues are adequately addressed. This framework is proposed as a first step in improving epidemiologic research practices through adherence to sound scientific research principles. Appendices provide an overview of standard operating procedures, a glossary of terms used in the Guidelines, and suggested references on occupational epidemiology methods.

  14. 40 CFR 1068.5 - How must manufacturers apply good engineering judgment?

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... engineering judgment? 1068.5 Section 1068.5 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY... PROGRAMS Applicability and Miscellaneous Provisions § 1068.5 How must manufacturers apply good engineering judgment? (a) You must use good engineering judgment for decisions related to any requirements under this...

  15. 40 CFR 1068.5 - How must manufacturers apply good engineering judgment?

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... engineering judgment? 1068.5 Section 1068.5 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY... PROGRAMS Applicability and Miscellaneous Provisions § 1068.5 How must manufacturers apply good engineering judgment? (a) You must use good engineering judgment for decisions related to any requirements under this...

  16. 40 CFR 1068.5 - How must manufacturers apply good engineering judgment?

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... engineering judgment? 1068.5 Section 1068.5 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY... PROGRAMS Applicability and Miscellaneous Provisions § 1068.5 How must manufacturers apply good engineering judgment? (a) You must use good engineering judgment for decisions related to any requirements under this...

  17. 2 CFR 176.170 - Notice of Required Use of American Iron, Steel, and Manufactured Goods (covered under...

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ..., Steel, and Manufactured Goods (covered under International Agreements)-Section 1605 of the American... Required Use of American Iron, Steel, and Manufactured Goods (covered under International Agreements... repair of a public building or public work, and involve iron, steel, and/or manufactured goods covered...

  18. 2 CFR 176.170 - Notice of Required Use of American Iron, Steel, and Manufactured Goods (covered under...

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ..., Steel, and Manufactured Goods (covered under International Agreements)-Section 1605 of the American... American Iron, Steel, and Manufactured Goods (covered under International Agreements)—Section 1605 of the... building or public work, and involve iron, steel, and/or manufactured goods covered under international...

  19. 2 CFR 176.170 - Notice of Required Use of American Iron, Steel, and Manufactured Goods (covered under...

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ..., Steel, and Manufactured Goods (covered under International Agreements)-Section 1605 of the American... Required Use of American Iron, Steel, and Manufactured Goods (covered under International Agreements... repair of a public building or public work, and involve iron, steel, and/or manufactured goods covered...

  20. 2 CFR 176.170 - Notice of Required Use of American Iron, Steel, and Manufactured Goods (covered under...

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ..., Steel, and Manufactured Goods (covered under International Agreements)-Section 1605 of the American... Iron, Steel, and Manufactured Goods (covered under International Agreements)—Section 1605 of the... building or public work, and involve iron, steel, and/or manufactured goods covered under international...

  1. 2 CFR 176.170 - Notice of Required Use of American Iron, Steel, and Manufactured Goods (covered under...

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ..., Steel, and Manufactured Goods (covered under International Agreements)-Section 1605 of the American... Notice of Required Use of American Iron, Steel, and Manufactured Goods (covered under International..., maintenance, or repair of a public building or public work, and involve iron, steel, and/or manufactured goods...

  2. 40 CFR 59.603 - How must manufacturers apply good engineering judgment?

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... engineering judgment? 59.603 Section 59.603 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY... and Applicability § 59.603 How must manufacturers apply good engineering judgment? (a) In addition to other requirements and prohibitions set forth in this subpart, you must use good engineering judgment...

  3. 40 CFR 59.603 - How must manufacturers apply good engineering judgment?

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... engineering judgment? 59.603 Section 59.603 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY... and Applicability § 59.603 How must manufacturers apply good engineering judgment? (a) In addition to other requirements and prohibitions set forth in this subpart, you must use good engineering judgment...

  4. 40 CFR 59.603 - How must manufacturers apply good engineering judgment?

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... engineering judgment? 59.603 Section 59.603 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY... and Applicability § 59.603 How must manufacturers apply good engineering judgment? (a) In addition to other requirements and prohibitions set forth in this subpart, you must use good engineering judgment...

  5. 40 CFR 59.603 - How must manufacturers apply good engineering judgment?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... engineering judgment? 59.603 Section 59.603 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY... and Applicability § 59.603 How must manufacturers apply good engineering judgment? (a) In addition to other requirements and prohibitions set forth in this subpart, you must use good engineering judgment...

  6. 40 CFR 1068.5 - How must manufacturers apply good engineering judgment?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... engineering judgment? 1068.5 Section 1068.5 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY... Miscellaneous Provisions § 1068.5 How must manufacturers apply good engineering judgment? (a) You must use good engineering judgment for decisions related to any requirements under this chapter. This includes your...

  7. 40 CFR 59.603 - How must manufacturers apply good engineering judgment?

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... engineering judgment? 59.603 Section 59.603 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY... and Applicability § 59.603 How must manufacturers apply good engineering judgment? (a) In addition to other requirements and prohibitions set forth in this subpart, you must use good engineering judgment...

  8. 40 CFR 1068.5 - How must manufacturers apply good engineering judgment?

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... engineering judgment? 1068.5 Section 1068.5 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY... Miscellaneous Provisions § 1068.5 How must manufacturers apply good engineering judgment? (a) You must use good engineering judgment for decisions related to any requirements under this chapter. This includes your...

  9. 2 CFR 176.110 - Evaluating proposals of foreign iron, steel, and/or manufactured goods.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 2 Grants and Agreements 1 2014-01-01 2014-01-01 false Evaluating proposals of foreign iron, steel... iron, steel, and/or manufactured goods. (a) If the award official receives a request for an exception based on the cost of certain domestic iron, steel, and/or manufactured goods being unreasonable, in...

  10. 2 CFR 176.110 - Evaluating proposals of foreign iron, steel, and/or manufactured goods.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 2 Grants and Agreements 1 2011-01-01 2011-01-01 false Evaluating proposals of foreign iron, steel... iron, steel, and/or manufactured goods. (a) If the award official receives a request for an exception based on the cost of certain domestic iron, steel, and/or manufactured goods being unreasonable, in...

  11. 2 CFR 176.110 - Evaluating proposals of foreign iron, steel, and/or manufactured goods.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 2 Grants and Agreements 1 2010-01-01 2010-01-01 false Evaluating proposals of foreign iron, steel... Evaluating proposals of foreign iron, steel, and/or manufactured goods. (a) If the award official receives a request for an exception based on the cost of certain domestic iron, steel, and/or manufactured goods...

  12. 2 CFR 176.110 - Evaluating proposals of foreign iron, steel, and/or manufactured goods.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 2 Grants and Agreements 1 2013-01-01 2013-01-01 false Evaluating proposals of foreign iron, steel... proposals of foreign iron, steel, and/or manufactured goods. (a) If the award official receives a request for an exception based on the cost of certain domestic iron, steel, and/or manufactured goods being...

  13. 2 CFR 176.110 - Evaluating proposals of foreign iron, steel, and/or manufactured goods.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 2 Grants and Agreements 1 2012-01-01 2012-01-01 false Evaluating proposals of foreign iron, steel... proposals of foreign iron, steel, and/or manufactured goods. (a) If the award official receives a request for an exception based on the cost of certain domestic iron, steel, and/or manufactured goods being...

  14. Good manufacturing practice production of [68Ga]Ga-ABY-025 for HER2 specific breast cancer imaging

    PubMed Central

    Velikyan, Irina; Wennborg, Anders; Feldwisch, Joachim; Lindman, Henrik; Carlsson, Jörgen; Sörensen, Jens

    2016-01-01

    Therapies targeting human epidermal growth factor receptor type 2 (HER2) have revolutionized breast cancer treatment, but require invasive biopsies and rigorous histopathology for optimal patient stratification. A non-invasive and quantitative diagnostic method such as positron emission tomography (PET) for the pre-therapeutic determination of the presence and density of the HER2 would significantly improve patient management efficacy and treatment cost. The essential part of the PET methodology is the production of the radiopharmaceutical in compliance with good manufacturing practice (GMP). The use of generator produced positron emitting 68Ga radionuclide would provide worldwide accessibility of the agent. GMP compliant, reliable and highly reproducible production of [68Ga]Ga-ABY-025 with control over the product peptide concentration and amount of radioactivity was accomplished within one hour. Two radiopharmaceuticals were developed differing in the total peptide content and were validated independently. The specific radioactivity could be kept similar throughout the study, and it was 6-fold higher for the low peptide content radiopharmaceutical. Intrapatient comparison of the two peptide doses allowed imaging optimization. The high peptide content decreased the uptake in healthy tissue, in particular liver, improving image contrast. The later imaging time points enhanced the contrast. The combination of high peptide content radiopharmaceutical and whole-body imaging at 2 hours post injection appeared to be optimal for routine clinical use. PMID:27186441

  15. Good Manufacturing Practices and Microbial Contamination Sources in Orange Fleshed Sweet Potato Puree Processing Plant in Kenya

    PubMed Central

    Abong', George Ooko

    2018-01-01

    Limited information exists on the status of hygiene and probable sources of microbial contamination in Orange Fleshed Sweet Potato (OFSP) puree processing. The current study is aimed at determining the level of compliance to Good Manufacturing Practices (GMPs), hygiene, and microbial quality in OFSP puree processing plant in Kenya. Intensive observation and interviews using a structured GMPs checklist, environmental sampling, and microbial analysis by standard microbiological methods were used in data collection. The results indicated low level of compliance to GMPs with an overall compliance score of 58%. Microbial counts on food equipment surfaces, installations, and personnel hands and in packaged OFSP puree were above the recommended microbial safety and quality legal limits. Steaming significantly (P < 0.05) reduced microbial load in OFSP cooked roots but the counts significantly (P < 0.05) increased in the puree due to postprocessing contamination. Total counts, yeasts and molds, Enterobacteriaceae, total coliforms, and E. coli and S. aureus counts in OFSP puree were 8.0, 4.0, 6.6, 5.8, 4.8, and 5.9 log10 cfu/g, respectively. In conclusion, equipment surfaces, personnel hands, and processing water were major sources of contamination in OFSP puree processing and handling. Plant hygiene inspection, environmental monitoring, and food safety trainings are recommended to improve hygiene, microbial quality, and safety of OFSP puree. PMID:29808161

  16. Good Manufacturing Practices and Microbial Contamination Sources in Orange Fleshed Sweet Potato Puree Processing Plant in Kenya.

    PubMed

    Malavi, Derick Nyabera; Muzhingi, Tawanda; Abong', George Ooko

    2018-01-01

    Limited information exists on the status of hygiene and probable sources of microbial contamination in Orange Fleshed Sweet Potato (OFSP) puree processing. The current study is aimed at determining the level of compliance to Good Manufacturing Practices (GMPs), hygiene, and microbial quality in OFSP puree processing plant in Kenya. Intensive observation and interviews using a structured GMPs checklist, environmental sampling, and microbial analysis by standard microbiological methods were used in data collection. The results indicated low level of compliance to GMPs with an overall compliance score of 58%. Microbial counts on food equipment surfaces, installations, and personnel hands and in packaged OFSP puree were above the recommended microbial safety and quality legal limits. Steaming significantly ( P < 0.05) reduced microbial load in OFSP cooked roots but the counts significantly ( P < 0.05) increased in the puree due to postprocessing contamination. Total counts, yeasts and molds, Enterobacteriaceae, total coliforms, and E. coli and S. aureus counts in OFSP puree were 8.0, 4.0, 6.6, 5.8, 4.8, and 5.9 log 10 cfu/g, respectively. In conclusion, equipment surfaces, personnel hands, and processing water were major sources of contamination in OFSP puree processing and handling. Plant hygiene inspection, environmental monitoring, and food safety trainings are recommended to improve hygiene, microbial quality, and safety of OFSP puree.

  17. Good Practices for Transforming Education

    ERIC Educational Resources Information Center

    Benavente, Ana; Panchaud, Christine

    2008-01-01

    This text is a guide to the reading and interpretation of the "good practices" that are developing in the countries participating in this project and elsewhere. A systematic approach to the factors making up a "good practice" has enabled us to share our analyses in a more structured manner and to reflect on their potential for…

  18. Safety and quality of food contact materials. Part 1: evaluation of analytical strategies to introduce migration testing into good manufacturing practice.

    PubMed

    Feigenbaum, A; Scholler, D; Bouquant, J; Brigot, G; Ferrier, D; Franzl, R; Lillemarktt, L; Riquet, A M; Petersen, J H; van Lierop, B; Yagoubi, N

    2002-02-01

    The results of a research project (EU AIR Research Programme CT94-1025) aimed to introduce control of migration into good manufacturing practice and into enforcement work are reported. Representative polymer classes were defined on the basis of chemical structure, technological function, migration behaviour and market share. These classes were characterized by analytical methods. Analytical techniques were investigated for identification of potential migrants. High-temperature gas chromatography was shown to be a powerful method and 1H-magnetic resonance provided a convenient fingerprint of plastic materials. Volatile compounds were characterized by headspace techniques, where it was shown to be essential to differentiate volatile compounds desorbed from those generated during the thermal desorption itself. For metal trace analysis, microwave mineralization followed by atomic absorption was employed. These different techniques were introduced into a systematic testing scheme that is envisaged as being suitable both for industrial control and for enforcement laboratories. Guidelines will be proposed in the second part of this paper.

  19. 21 CFR 146.151 - Orange juice for manufacturing.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... apply to the hybrid species described in § 146.135). Seeds (except embryonic seeds and small fragments of seeds that cannot be separated by good manufacturing practice) are removed, and pulp and orange oil may be adjusted in accordance with good manufacturing practice. If pulp is added it shall be other...

  20. Validation of 64Cu-DOTA-rituximab injection preparation under good manufacturing practices: a PET tracer for imaging of B-cell non-Hodgkin lymphoma.

    PubMed

    Natarajan, Arutselvan; Arksey, Natasha; Iagaru, Andrei; Chin, Frederick T; Gambhir, Sanjiv Sam

    2015-01-01

    Manufacturing of 64Cu-1,4,7,10-tetraazacyclododecane-N,N',N'',N'''-tetraacetic acid (DOTA)-rituximab injection under good manufacturing practices (GMP) was validated for imaging of patients with CD20+ B-cell non-Hodgkin lymphoma. Rituximab was purified by size exclusion high performance liquid chromatography (HPLC) and conjugated to DOTA-mono-(N-hydroxysuccinimidyl) ester. 64CuCl2, buffers, reagents, and other raw materials were obtained as high-grade quality. Following a semi-automated synthesis of 64Cu-DOTA-rituximab, a series of quality control tests was performed. The product was further tested in vivo using micro-positron emission tomography/computed tomography (PET/CT) to assess targeting ability towards human CD20 in transgenic mice. Three batches of 64Cu-DOTA-rituximab final product were prepared as per GMP specifications. The radiolabeling yield from these batches was 93.1 ± 5.8%; these provided final product with radiopharmaceutical yield, purity, and specific activity of 59.2 ± 5.1% (0.9 ± 0.1 GBq of 64Cu), > 95% (by HPLC and radio-thin layer chromatography), and 229.4 ± 43.3 GBq/µmol (or 1.5 ± 0.3 MBq/µg), respectively. The doses passed apyrogenicity and human serum stability specifications, were sterile up to 14 days, and retained > 60% immunoreactivity. In vivo micro-PET/CT mouse images at 24 hours postinjection showed that the tracer targeted the intended sites of human CD20 expression. Thus, we have validated the manufacturing of GMP grade 64Cu-DOTA-rituximab for injection in the clinical setting.

  1. 2 CFR 176.140 - Award term-Required Use of American Iron, Steel, and Manufactured Goods-Section 1605 of the...

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ..., Steel, and Manufactured Goods-Section 1605 of the American Recovery and Reinvestment Act of 2009. 176... Reinvestment Act of 2009 § 176.140 Award term—Required Use of American Iron, Steel, and Manufactured Goods..., steel, and/or manufactured goods covered under international agreements, the agency shall use the award...

  2. Lot-to-lot consistency of live attenuated SA 14-14-2 Japanese encephalitis vaccine manufactured in a good manufacturing practice facility and non-inferiority with respect to an earlier product.

    PubMed

    Zaman, K; Naser, Abu Mohd; Power, Maureen; Yaich, Mansour; Zhang, Lei; Ginsburg, Amy Sarah; Luby, Stephen P; Rahman, Mahmudur; Hills, Susan; Bhardwaj, Mukesh; Flores, Jorge

    2014-10-21

    We conducted a four-arm, double-blind, randomized controlled trial among 818 Bangladeshi infants between 10 and 12 months of age to establish equivalence among three lots of live attenuated SA 14-14-2 JE vaccine manufactured by the China National Biotec Group's Chengdu Institute of Biological Products (CDIBP) in a new Good Manufacturing Practice (GMP) facility and to evaluate non-inferiority of the product with a lot of the same vaccine manufactured in CDIBP's original facility. The study took place in two sites in Bangladesh, rural Matlab and Mirpur in urban Dhaka. We collected pre-vaccination (Day 0) and post-vaccination Day 28 (-4 to +14 days) blood samples to assess neutralizing anti-JE virus antibody titers in serum by plaque reduction neutralization tests (PRNT). Seroprotection following vaccination was defined as a PRNT titer ≥1:10 at Day 28 in participants non-immune at baseline. Follow-up for reactogenicity and safety was conducted through home visits at Day 7 and monitoring for serious adverse events through Day 28. Seroprotection rates ranged from 80.2% to 86.3% for all four lots of vaccine. Equivalence of the seroprotection rates between pairs of vaccine lots produced in the new GMP facility was satisfied at the pre-specified 10% margin of the 95% confidence interval (CI) for two of the three pairwise comparisons, but not for the third (-4.3% observed difference with 95% CI of -11.9 to 3.3%). Nevertheless, the aggregate seroprotection rate for all three vaccine lots manufactured in the GMP facility was calculated and found to be within the non-inferiority margin (within 10%) to the vaccine lot produced in the original facility. All four lots of vaccine were safe and well tolerated. These study results should facilitate the use of SA 14-14-2 JE vaccine as a routine component of immunization programs in Asian countries. Copyright © 2014 Elsevier Ltd. All rights reserved.

  3. 2 CFR 176.140 - Award term-Required Use of American Iron, Steel, and Manufactured Goods-Section 1605 of the...

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ..., Steel, and Manufactured Goods-Section 1605 of the American Recovery and Reinvestment Act of 2009. 176... Reinvestment Act of 2009 § 176.140 Award term—Required Use of American Iron, Steel, and Manufactured Goods..., steel, and/or manufactured goods covered under international agreements, the agency shall use the award...

  4. Continuous Manufacturing in Pharmaceutical Process Development and Manufacturing.

    PubMed

    Burcham, Christopher L; Florence, Alastair J; Johnson, Martin D

    2018-06-07

    The pharmaceutical industry has found new applications for the use of continuous processing for the manufacture of new therapies currently in development. The transformation has been encouraged by regulatory bodies as well as driven by cost reduction, decreased development cycles, access to new chemistries not practical in batch, improved safety, flexible manufacturing platforms, and improved product quality assurance. The transformation from batch to continuous manufacturing processing is the focus of this review. The review is limited to small, chemically synthesized organic molecules and encompasses the manufacture of both active pharmaceutical ingredients (APIs) and the subsequent drug product. Continuous drug product is currently used in approved processes. A few examples of production of APIs under current good manufacturing practice conditions using continuous processing steps have been published in the past five years, but they are lagging behind continuous drug product with respect to regulatory filings.

  5. 2 CFR 176.150 - Notice of Required Use of American Iron, Steel, and Manufactured Goods-Section 1605 of the...

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ..., Steel, and Manufactured Goods-Section 1605 of the American Recovery and Reinvestment Act of 2009. 176... Reinvestment Act of 2009 § 176.150 Notice of Required Use of American Iron, Steel, and Manufactured Goods... repair of a public building or public work, and do not involve iron, steel, and/or manufactured goods...

  6. 2 CFR 176.150 - Notice of Required Use of American Iron, Steel, and Manufactured Goods-Section 1605 of the...

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ..., Steel, and Manufactured Goods-Section 1605 of the American Recovery and Reinvestment Act of 2009. 176... Reinvestment Act of 2009 § 176.150 Notice of Required Use of American Iron, Steel, and Manufactured Goods... repair of a public building or public work, and do not involve iron, steel, and/or manufactured goods...

  7. HEALTH TECHNOLOGY ASSESSMENT FOR DECISION MAKING IN LATIN AMERICA: GOOD PRACTICE PRINCIPLES.

    PubMed

    Pichon-Riviere, Andrés; Soto, Natalie C; Augustovski, Federico Ariel; García Martí, Sebastián; Sampietro-Colom, Laura

    2018-06-11

    The aim of this study was to identify good practice principles for health technology assessment (HTA) that are the most relevant and of highest priority for application in Latin America and to identify potential barriers to their implementation in the region. HTA good practice principles proposed at the international level were identified and then explored during a deliberative process in a forum of assessors, funders, and product manufacturers. Forty-two representatives from ten Latin American countries participated. Good practice principles proposed at the international level were considered valid and potentially relevant to Latin America. Five principles were identified as priority and with the greatest potential to be strengthened at this time: transparency in the production of HTA, involvement of relevant stakeholders in the HTA process, mechanisms to appeal decisions, clear priority-setting processes in HTA, and a clear link between HTA and decision making. The main challenge identified was to find a balance between the application of these principles and the available resources in a way that would not detract from the production of reports and adaptation to the needs of decision makers. The main recommendation was to progress gradually in strengthening HTA and its link to decision making by developing appropriate processes for each country, without trying to impose, in the short-term, standards taken from examples at the international level without adequate adaptation of these to local contexts.

  8. 75 FR 40840 - Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-14

    ... Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements... regulations regarding current good manufacturing practice (CGMP) for dietary supplements. DATES: Submit either... in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements--21 CFR Part 111...

  9. Assessment of the readiness of SME to entering the modern market by using the good manufacturing practice and halal assurance system (Case study on Sari Murni SME)

    NASA Astrophysics Data System (ADS)

    Dewantara, Achmad Samudra; Liquiddanu, Eko; Rosyidi, Cucuk Nur; Hisjam, Muh.; Yuniaristanto

    2018-02-01

    Sari Murni (SM) is one of the SME that produces tofu in Krajan Surakarta. In the process of marketing, The SM sells their product to traditional market and has made an attempt to enter modern market. One of the requirement of tofu product to enter the modern market is that tofu product must have a GMP licence (household industry licence). A benchmarking is conducted to compare the production process of SM with other established tofu producer intern of good manufacturing practice (GMP). The basic aim of GMP is concern with the precaution needed to ensure all quality and safety basic requirement (Rotaru dkk, 2005). In addition, the halal licence is also an important requirement for a product to enter the modern market. To obtain the halal licence it is necessary to first assess the performance of halal assurance of the SME. If the grade of performance halal of halal assurance system is below the B level then the SME will not be able to get halal licence. Based on the result, the level of the non-conformity of good manufacturing practice (GMP) in SM is 4 and the result of halal assurance system for SM is C.so according to the result, SM needs to make some improvement to reduce the level of non-conformity of the GMP and improve the performance of halal assurance system in order to obtain a minimum grade. To start the improvement then the analysis of HACCP (hazard analysis critical control point) is performed to determine the location of critical point which has the possibility to contaminate the tofu product so after mapping the location of critical control point then the SM can make improvement intern of equipment process and environment.

  10. Practical Framework: Implementing OEE Method in Manufacturing Process Environment

    NASA Astrophysics Data System (ADS)

    Maideen, N. C.; Sahudin, S.; Mohd Yahya, N. H.; Norliawati, A. O.

    2016-02-01

    Manufacturing process environment requires reliable machineries in order to be able to satisfy the market demand. Ideally, a reliable machine is expected to be operated and produce a quality product at its maximum designed capability. However, due to some reason, the machine usually unable to achieved the desired performance. Since the performance will affect the productivity of the system, a measurement technique should be applied. Overall Equipment Effectiveness (OEE) is a good method to measure the performance of the machine. The reliable result produced from OEE can then be used to propose a suitable corrective action. There are a lot of published paper mentioned about the purpose and benefit of OEE that covers what and why factors. However, the how factor not yet been revealed especially the implementation of OEE in manufacturing process environment. Thus, this paper presents a practical framework to implement OEE and a case study has been discussed to explain in detail each steps proposed. The proposed framework is beneficial to the engineer especially the beginner to start measure their machine performance and later improve the performance of the machine.

  11. Good manufacturing practice-compliant expansion of marrow-derived stem and progenitor cells for cell therapy.

    PubMed

    Gastens, Martin H; Goltry, Kristin; Prohaska, Wolfgang; Tschöpe, Diethelm; Stratmann, Bernd; Lammers, Dirk; Kirana, Stanley; Götting, Christian; Kleesiek, Knut

    2007-01-01

    production of good manufacturing practice (GMP)-compliant cell therapeutics, ready for use within a clinical setting, with minimal risk of microbial contamination.

  12. Bioprocessing of plant-derived virus-like particles of Norwalk virus capsid protein under current Good Manufacture Practice regulations

    PubMed Central

    Lai, Huafang; Chen, Qiang

    2012-01-01

    Despite the success in expressing a variety of subunit vaccine proteins in plants and the recent stride in improving vaccine accumulation levels by transient expression systems, there is still no plant-derived vaccine that has been licensed for human use. The lack of commercial success of plant-made vaccines lies in several technical and regulatory barriers that remain to be overcome. These challenges include the lack of scalable downstream processing procedures, the uncertainty of regulatory compliance of production processes, and the lack of demonstration of plant-derived products that meet the required standards of regulatory agencies in identity, purity, potency and safety. In this study, we addressed these remaining challenges and successfully demonstrate the ability of using plants to produce a pharmaceutical grade Norwalk virus (NV) vaccine under current Good Manufacture Practice (cGMP) guidelines at multiple gram scales. Our results demonstrate that an efficient and scalable extraction and purification scheme can established for processing virus-like particles (VLP) of NV capsid protein (NVCP). We successfully operated the upstream and downstream NVCP production processes under cGMP regulations. Furthermore, plant-derived NVCP VLP demonstrates the identity, purity, potency and safety that meet the preset release specifications. This material is being tested in a Phase I human clinical trial. This research provides the first report of producing a plant-derived vaccine at scale under cGMP regulations in an academic setting and an important step for plant-produced vaccines to become a commercial reality. PMID:22134876

  13. 2 CFR 176.150 - Notice of Required Use of American Iron, Steel, and Manufactured Goods-Section 1605 of the...

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ..., Steel, and Manufactured Goods-Section 1605 of the American Recovery and Reinvestment Act of 2009. 176... Iron, Steel, and Manufactured Goods—Section 1605 of the American Recovery and Reinvestment Act of 2009..., steel, and/or manufactured goods covered under international agreements, the agency shall use the notice...

  14. Good pharmacovigilance practices: technology enabled.

    PubMed

    Nelson, Robert C; Palsulich, Bruce; Gogolak, Victor

    2002-01-01

    The assessment of spontaneous reports is most effective it is conducted within a defined and rigorous process. The framework for good pharmacovigilance process (GPVP) is proposed as a subset of good postmarketing surveillance process (GPMSP), a functional structure for both a public health and corporate risk management strategy. GPVP has good practices that implement each step within a defined process. These practices are designed to efficiently and effectively detect and alert the drug safety professional to new and potentially important information on drug-associated adverse reactions. These practices are enabled by applied technology designed specifically for the review and assessment of spontaneous reports. Specific practices include rules-based triage, active query prompts for severe organ insults, contextual single case evaluation, statistical proportionality and correlational checks, case-series analyses, and templates for signal work-up and interpretation. These practices and the overall GPVP are supported by state-of-the-art web-based systems with powerful analytical engines, workflow and audit trials to allow validated systems support for valid drug safety signalling efforts. It is also important to understand that a process has a defined set of steps and any one cannot stand independently. Specifically, advanced use of technical alerting methods in isolation can mislead and allow one to misunderstand priorities and relative value. In the end, pharmacovigilance is a clinical art and a component process to the science of pharmacoepidemiology and risk management.

  15. 2 CFR 176.140 - Award term-Required Use of American Iron, Steel, and Manufactured Goods-Section 1605 of the...

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ..., Steel, and Manufactured Goods-Section 1605 of the American Recovery and Reinvestment Act of 2009. 176... American Iron, Steel, and Manufactured Goods—Section 1605 of the American Recovery and Reinvestment Act of... building or public work that does not involve iron, steel, and/or manufactured goods covered under...

  16. 78 FR 76836 - Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-19

    ... Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements... of FDA's regulations regarding current good manufacturing practice (CGMP) for dietary supplements..., or Holding Operations for Dietary Supplements--21 CFR Part 111 (OMB Control Number 0910-0606...

  17. Good documentation practice in clinical research.

    PubMed

    Bargaje, Chitra

    2011-04-01

    One of the most common inspection findings in investigator site inspections is lack of reliable, accurate and adequate source documentation. This also happens to be the most common pitfall identified during sponsor audits. The importance of good documentation practice needs to be emphasized to investigator sites to ensure that the study results are built on the foundation of credible and valid data. This article focuses on the key principles of good documentation practice and offers suggestions for improvement.

  18. Integrating Education: Parekhian Multiculturalism and Good Practice

    ERIC Educational Resources Information Center

    McGlynn, Claire

    2009-01-01

    This paper explores the concept of good practice in integrating education in divided societies. Using Northern Ireland as a case study, the paper draws on data from eight schools (both integrated Catholic and Protestant, and separate) that are identified as exemplifying good practice in response to cultural diversity. Analysis is provided through…

  19. Good documentation practice in clinical research

    PubMed Central

    Bargaje, Chitra

    2011-01-01

    One of the most common inspection findings in investigator site inspections is lack of reliable, accurate and adequate source documentation. This also happens to be the most common pitfall identified during sponsor audits. The importance of good documentation practice needs to be emphasized to investigator sites to ensure that the study results are built on the foundation of credible and valid data. This article focuses on the key principles of good documentation practice and offers suggestions for improvement. PMID:21731856

  20. Teleworking: Guidelines for Good Practice. IES Report 329.

    ERIC Educational Resources Information Center

    Huws, Ursula; And Others

    Because teleworking presents major new challenges to human resource managers, trade unions, and others involved in the development of good employment practices, this book provides practical guidelines for good practice in regard to teleworkers that recognize that teleworking is not a single category, but covers at least five distinct groups with…

  1. 21 CFR 1271.150 - Current good tissue practice requirements.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Current good tissue practice requirements. 1271... HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS Current Good Tissue Practice § 1271.150 Current good tissue practice requirements. (a) General. This subpart D and subpart C of this part set...

  2. Good Laboratory Practice. Part 3. Implementing Good Laboratory Practice in the Analytical Lab

    ERIC Educational Resources Information Center

    Wedlich, Richard C.; Pires, Amanda; Fazzino, Lisa; Fransen, Joseph M.

    2013-01-01

    Laboratories submitting experimental results to the Food and Drug Administration (FDA) or the Environmental Protection Agency (EPA) in support of Good Laboratory Practice (GLP) nonclinical laboratory studies must conduct such work in compliance with the GLP regulations. To consistently meet these requirements, lab managers employ a "divide…

  3. [Evaluation of good manufacturing practices in the elaboration of enteral formulas in public hospitals of Santiago (Chile)].

    PubMed

    Lara González, Sandra; Domecq Jendres, C; Atalah Samur, Eduardo

    2013-11-01

    The development of enteral formulas (FE) is subject to various risks of contamination. The World Health Organization (WHO) and the Food and Agriculture Organization (FAO), have worried about alerting, recommendations and documents released to prevent contamination the FE, suggesting the standardization and protocols for all procedures involved. The study was aimed to evaluate compliance with the technical criteria contained in a Guideline for Good Practice of Manufacture in relation to the development, maintenance and administration of enteral nutrition in hospitals of Santiago, in the Metropolitan Area. The verification criteria considered Physical Plant, Equipment and Implementation, Hygienic and Sanitary Standards, Human Resources, Organization and Management, Safety and Warranty Quality Assurance. 639 criteria were defined, 309 risk Type 1, by mayor risk of producing pollution. The study was conducted by observing Central Units Enteral Formulas and interview with the caregiver. Medium of compliance for each group of criteria risk 1 and overall, was analyzed. A total of 14 public hospitals were studied. The degree of compliance with the 639 reached a median of 33.2% (p25-75 31.6%-40.4%), with the lowest value for physical plant with 27.9% (p25-75 23.9%-38.2%) and the highest for human resources with 52.4% (p25-75 44.1%-52.4%). Median compliance for risk criteria Type 1 was only 31.8% (p25-75 27.5%-41.2%). Most of the units tested, meets less than half of the internationals recommendations, or the Ministry of Health of Chile. It should develop protocols and train staff to ensure quality and safety in the development of enteral formulas and reduce risk of infection. Copyright AULA MEDICA EDICIONES 2013. Published by AULA MEDICA. All rights reserved.

  4. Impact of Company Size on Manufacturing Improvement Practices: An empirical study

    NASA Astrophysics Data System (ADS)

    Syan, C. S.; Ramoutar, K.

    2014-07-01

    There is a constant search for ways to achieve a competitive advantage through new manufacturing techniques. Best performing manufacturing companies tend to use world-class manufacturing (WCM) practices. Although the last few years have witnessed phenomenal growth in the use of WCM techniques, their effectiveness is not well understood specifically in the context of less developed countries. This paper presents an empirical study to investigate the impact of company size on improving manufacturing performance in manufacturing organizations based in Trinidad and Tobago (T&T). Empirical data were collected via a questionnaire survey which was send to 218 manufacturing firms in T&T. Five different company sizes and seven different industry sectors were studied. The analysis of survey data was performed with the aid of Statistical Package for Social Sciences (SPSS) software. The study signified facilitating and impeding factors towards improving manufacturing performance. Their relative impact/importance is dependent on varying company size and industry sectors. Findings indicate that T&T manufacturers are still practicing traditional approaches, when compared with world class manufacturers. In the majority of organizations, these practices were not 100% implemented even though they started the implementation process more than 5 years ago. The findings provided some insights in formulating more optimal operational strategies, and later develop action plans towards more effective implementation of WCM in T&T manufacturers.

  5. 2 CFR 176.140 - Award term-Required Use of American Iron, Steel, and Manufactured Goods-Section 1605 of the...

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ..., Steel, and Manufactured Goods-Section 1605 of the American Recovery and Reinvestment Act of 2009. 176... and Reinvestment Act of 2009 § 176.140 Award term—Required Use of American Iron, Steel, and... that does not involve iron, steel, and/or manufactured goods covered under international agreements...

  6. 2 CFR 176.140 - Award term-Required Use of American Iron, Steel, and Manufactured Goods-Section 1605 of the...

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ..., Steel, and Manufactured Goods-Section 1605 of the American Recovery and Reinvestment Act of 2009. 176... and Reinvestment Act of 2009 § 176.140 Award term—Required Use of American Iron, Steel, and... that does not involve iron, steel, and/or manufactured goods covered under international agreements...

  7. 48 CFR 52.225-21 - Required Use of American Iron, Steel, and Manufactured Goods-Buy American Statute-Construction...

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... Iron, Steel, and Manufactured Goods-Buy American Statute-Construction Materials. 52.225-21 Section 52... of American Iron, Steel, and Manufactured Goods—Buy American Statute—Construction Materials. As prescribed in 25.1102(e), insert the following clause: Required Use of American Iron, Steel, and Manufactured...

  8. Top 10 metrics for life science software good practices.

    PubMed

    Artaza, Haydee; Chue Hong, Neil; Corpas, Manuel; Corpuz, Angel; Hooft, Rob; Jimenez, Rafael C; Leskošek, Brane; Olivier, Brett G; Stourac, Jan; Svobodová Vařeková, Radka; Van Parys, Thomas; Vaughan, Daniel

    2016-01-01

    Metrics for assessing adoption of good development practices are a useful way to ensure that software is sustainable, reusable and functional. Sustainability means that the software used today will be available - and continue to be improved and supported - in the future. We report here an initial set of metrics that measure good practices in software development. This initiative differs from previously developed efforts in being a community-driven grassroots approach where experts from different organisations propose good software practices that have reasonable potential to be adopted by the communities they represent. We not only focus our efforts on understanding and prioritising good practices, we assess their feasibility for implementation and publish them here.

  9. Top 10 metrics for life science software good practices

    PubMed Central

    2016-01-01

    Metrics for assessing adoption of good development practices are a useful way to ensure that software is sustainable, reusable and functional. Sustainability means that the software used today will be available - and continue to be improved and supported - in the future. We report here an initial set of metrics that measure good practices in software development. This initiative differs from previously developed efforts in being a community-driven grassroots approach where experts from different organisations propose good software practices that have reasonable potential to be adopted by the communities they represent. We not only focus our efforts on understanding and prioritising good practices, we assess their feasibility for implementation and publish them here. PMID:27635232

  10. 48 CFR 52.225-21 - Required Use of American Iron, Steel, and Manufactured Goods-Buy American Act-Construction...

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... Iron, Steel, and Manufactured Goods-Buy American Act-Construction Materials. 52.225-21 Section 52.225... of American Iron, Steel, and Manufactured Goods—Buy American Act—Construction Materials. As prescribed in 25.1102(e), insert the following clause: Required Use of American Iron, Steel, and Manufactured...

  11. 48 CFR 52.225-21 - Required Use of American Iron, Steel, and Manufactured Goods-Buy American Act-Construction...

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... Iron, Steel, and Manufactured Goods-Buy American Act-Construction Materials. 52.225-21 Section 52.225... of American Iron, Steel, and Manufactured Goods—Buy American Act—Construction Materials. As prescribed in 25.1102(e), insert the following clause: Required Use of American Iron, Steel, and Manufactured...

  12. 48 CFR 52.225-21 - Required Use of American Iron, Steel, and Manufactured Goods-Buy American Act-Construction...

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... Iron, Steel, and Manufactured Goods-Buy American Act-Construction Materials. 52.225-21 Section 52.225... of American Iron, Steel, and Manufactured Goods—Buy American Act—Construction Materials. As prescribed in 25.1102(e), insert the following clause: Required Use of American Iron, Steel, and Manufactured...

  13. 48 CFR 52.225-21 - Required Use of American Iron, Steel, and Manufactured Goods-Buy American Act-Construction...

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... Iron, Steel, and Manufactured Goods-Buy American Act-Construction Materials. 52.225-21 Section 52.225... of American Iron, Steel, and Manufactured Goods—Buy American Act—Construction Materials. As prescribed in 25.1102(e), insert the following clause: Required Use of American Iron, Steel, and Manufactured...

  14. [What everybody should know about good clinical practices].

    PubMed

    Osorio, Lyda

    2015-01-01

    An increasing number of countries are adopting good clinical practices guidelines as part of the regulation of clinical studies to register pharmaceutical products and other health-related products. Consequently, all parties involved in the research and development of these products should know them, implement them and ensure their compliance. However, good clinical practices guidelines are just one of the initiatives seeking to achieve the highest ethical and scientific standards in health research and in other areas where humans are research subjects. This review defines such practices and their objectives presenting in a practical manner their legal framework in Colombia, and clarifying their application in studies where interventions use no medications or those that are not clinical trials. Finally, the work discusses the challenges to ensure that good clinical practices contribute to the protection of research participants, the education of trustworthy health professionals, and a culture of respect for human beings.

  15. Regulatory and quality considerations for continuous manufacturing. May 20-21, 2014 Continuous Manufacturing Symposium.

    PubMed

    Allison, Gretchen; Cain, Yanxi Tan; Cooney, Charles; Garcia, Tom; Bizjak, Tara Gooen; Holte, Oyvind; Jagota, Nirdosh; Komas, Bekki; Korakianiti, Evdokia; Kourti, Dora; Madurawe, Rapti; Morefield, Elaine; Montgomery, Frank; Nasr, Moheb; Randolph, William; Robert, Jean-Louis; Rudd, Dave; Zezza, Diane

    2015-03-01

    This paper assesses the current regulatory environment, relevant regulations and guidelines, and their impact on continuous manufacturing. It summarizes current regulatory experience and learning from both review and inspection perspectives. It outlines key regulatory aspects, including continuous manufacturing process description and control strategy in regulatory files, process validation, and key Good Manufacturing Practice (GMP) requirements. In addition, the paper identifies regulatory gaps and challenges and proposes a way forward to facilitate implementation. © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association.

  16. Cryopreservation of human vascular umbilical cord cells under good manufacturing practice conditions for future cell banks

    PubMed Central

    2012-01-01

    Background In vitro fabricated tissue engineered vascular constructs could provide an alternative to conventional substitutes. A crucial factor for tissue engineering of vascular constructs is an appropriate cell source. Vascular cells from the human umbilical cord can be directly isolated and cryopreserved until needed. Currently no cell bank for human vascular cells is available. Therefore, the establishment of a future human vascular cell bank conforming to good manufacturing practice (GMP) conditions is desirable for therapeutic applications such as tissue engineered cardiovascular constructs. Materials and methods A fundamental step was the adaption of conventional research and development starting materials to GMP compliant starting materials. Human umbilical cord artery derived cells (HUCAC) and human umbilical vein endothelial cells (HUVEC) were isolated, cultivated, cryopreserved (short- and long-term) directly after primary culture and recultivated subsequently. Cell viability, expression of cellular markers and proliferation potential of fresh and cryopreserved cells were studied using trypan blue staining, flow cytometry analysis, immunofluorescence staining and proliferation assays. Statistical analyses were performed using Student’s t-test. Results Sufficient numbers of isolated cells with acceptable viabilities and homogenous expression of cellular markers confirmed that the isolation procedure was successful using GMP compliant starting materials. The influence of cryopreservation was marginal, because cryopreserved cells mostly maintain phenotypic and functional characteristics similar to those of fresh cells. Phenotypic studies revealed that fresh cultivated and cryopreserved HUCAC were positive for alpha smooth muscle actin, CD90, CD105, CD73, CD29, CD44, CD166 and negative for smoothelin. HUVEC expressed CD31, CD146, CD105 and CD144 but not alpha smooth muscle actin. Functional analysis demonstrated acceptable viability and sufficient

  17. Cryopreservation of human vascular umbilical cord cells under good manufacturing practice conditions for future cell banks.

    PubMed

    Polchow, Bianca; Kebbel, Kati; Schmiedeknecht, Gerno; Reichardt, Anne; Henrich, Wolfgang; Hetzer, Roland; Lueders, Cora

    2012-05-16

    In vitro fabricated tissue engineered vascular constructs could provide an alternative to conventional substitutes. A crucial factor for tissue engineering of vascular constructs is an appropriate cell source. Vascular cells from the human umbilical cord can be directly isolated and cryopreserved until needed. Currently no cell bank for human vascular cells is available. Therefore, the establishment of a future human vascular cell bank conforming to good manufacturing practice (GMP) conditions is desirable for therapeutic applications such as tissue engineered cardiovascular constructs. A fundamental step was the adaption of conventional research and development starting materials to GMP compliant starting materials. Human umbilical cord artery derived cells (HUCAC) and human umbilical vein endothelial cells (HUVEC) were isolated, cultivated, cryopreserved (short- and long-term) directly after primary culture and recultivated subsequently. Cell viability, expression of cellular markers and proliferation potential of fresh and cryopreserved cells were studied using trypan blue staining, flow cytometry analysis, immunofluorescence staining and proliferation assays. Statistical analyses were performed using Student's t-test. Sufficient numbers of isolated cells with acceptable viabilities and homogenous expression of cellular markers confirmed that the isolation procedure was successful using GMP compliant starting materials. The influence of cryopreservation was marginal, because cryopreserved cells mostly maintain phenotypic and functional characteristics similar to those of fresh cells. Phenotypic studies revealed that fresh cultivated and cryopreserved HUCAC were positive for alpha smooth muscle actin, CD90, CD105, CD73, CD29, CD44, CD166 and negative for smoothelin. HUVEC expressed CD31, CD146, CD105 and CD144 but not alpha smooth muscle actin. Functional analysis demonstrated acceptable viability and sufficient proliferation properties of cryopreserved HUCAC

  18. 48 CFR 52.225-22 - Notice of Required Use of American Iron, Steel, and Manufactured Goods-Buy American Statute...

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... American Iron, Steel, and Manufactured Goods-Buy American Statute-Construction Materials. 52.225-22 Section... of Required Use of American Iron, Steel, and Manufactured Goods—Buy American Statute—Construction... Iron, Steel, and Manufactured Goods—Buy American Statute—Construction Materials (MAY 2014) (a...

  19. 48 CFR 52.225-24 - Notice of Required Use of American Iron, Steel, and Manufactured Goods-Buy American Statute...

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... American Iron, Steel, and Manufactured Goods-Buy American Statute-Construction Materials Under Trade....225-24 Notice of Required Use of American Iron, Steel, and Manufactured Goods—Buy American Statute...: Notice of Required Use of American Iron, Steel, and Manufactured Goods—Buy American Statute—Construction...

  20. 48 CFR 52.225-24 - Notice of Required Use of American Iron, Steel, and Manufactured Goods-Buy American Act...

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... American Iron, Steel, and Manufactured Goods-Buy American Act-Construction Materials Under Trade Agreements....225-24 Notice of Required Use of American Iron, Steel, and Manufactured Goods—Buy American Act...: Notice of Required Use of American Iron, Steel, and Manufactured Goods—Buy American Act—Construction...

  1. Good Practice and Recommendations for Research Team Leadership

    DTIC Science & Technology

    2017-05-01

    ARL-SR-0372 ● MAY 2017 US Army Research Laboratory Good Practice and Recommendations for Research Team Leadership by Mark L...Do not return it to the originator. ARL-SR-0372 ● MAY 2017 US Army Research Laboratory Good Practice and Recommendations for...information, including suggestions for reducing the burden, to Department of Defense, Washington Headquarters Services , Directorate for Information

  2. 21 CFR 111.210 - What must the master manufacturing record include?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING... manufactured and the strength, concentration, weight, or measure of each dietary ingredient for each batch size... actual or representative label; (h) Written instructions, including the following: (1) Specifications for...

  3. Creative Practice : Design and Manufacturing of ‘CD Crusher’

    NASA Astrophysics Data System (ADS)

    Yamamoto, Koji; Senda, Shinkoh; Fukumori, Tsutom; Sato, Kazuo

    A practice program for graduate students in mechanical engineering has been developed. The task of this training is to design and manufacture an original ‘CD crusher’ , a machine to mechanically destroy compact disks after use. This is a competition among groups of students creating their original CD crusher which fulfills the regulation. The regulation is that the crusher has to use rotational blades cutting the CDs. Same sized blades are supplied to the students groups. They are fabricated from a steel bar through cutting, annealing and quenching processes by the presence of students. Technical staffs are ready to help students on the whole way of the practice. However, they encourage initiative by the students from planning to manufacturing. Students satisfied at the practice according to the comments after competition.

  4. Regulatory and Quality Considerations for Continuous Manufacturing May 20-21, 2014 Continuous Manufacturing Symposium.

    PubMed

    Allison, Gretchen; Cain, Yanxi Tan; Cooney, Charles; Garcia, Tom; Bizjak, Tara Gooen; Holte, Oyvind; Jagota, Nirdosh; Komas, Bekki; Korakianiti, Evdokia; Kourti, Dora; Madurawe, Rapti; Morefield, Elaine; Montgomery, Frank; Nasr, Moheb; Randolph, William; Robert, Jean-Louis; Rudd, Dave; Zezza, Diane

    2015-03-01

    This paper assesses the current regulatory environment, relevant regulations and guidelines, and their impact on continuous manufacturing. It summarizes current regulatory experience and learning from both review and inspection perspectives. It outlines key regulatory aspects, including continuous manufacturing process description and control strategy in regulatory files, process validation, and key Good Manufacturing Practice (GMP) requirements. In addition, the paper identifies regulatory gaps and challenges and proposes a way forward to facilitate implementation. © 2015 Wiley Periodicals, Inc. and the American Pharmacists Association. © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association.

  5. Good Cell Culture Practice for stem cells and stem-cell-derived models.

    PubMed

    Pamies, David; Bal-Price, Anna; Simeonov, Anton; Tagle, Danilo; Allen, Dave; Gerhold, David; Yin, Dezhong; Pistollato, Francesca; Inutsuka, Takashi; Sullivan, Kristie; Stacey, Glyn; Salem, Harry; Leist, Marcel; Daneshian, Mardas; Vemuri, Mohan C; McFarland, Richard; Coecke, Sandra; Fitzpatrick, Suzanne C; Lakshmipathy, Uma; Mack, Amanda; Wang, Wen Bo; Yamazaki, Daiju; Sekino, Yuko; Kanda, Yasunari; Smirnova, Lena; Hartung, Thomas

    2017-01-01

    The first guidance on Good Cell Culture Practice (GCCP) dates back to 2005. This document expands this to include aspects of quality assurance for in vitro cell culture focusing on the increasingly diverse cell types and culture formats used in research, product development, testing and manufacture of biotechnology products and cell-based medicines. It provides a set of basic principles of best practice that can be used in training new personnel, reviewing and improving local procedures, and helping to assure standard practices and conditions for the comparison of data between laboratories and experimentation performed at different times. This includes recommendations for the documentation and reporting of culture conditions. It is intended as guidance to facilitate the generation of reliable data from cell culture systems, and is not intended to conflict with local or higher level legislation or regulatory requirements. It may not be possible to meet all recommendations in this guidance for practical, legal or other reasons. However, when it is necessary to divert from the principles of GCCP, the risk of decreasing the quality of work and the safety of laboratory staff should be addressed and any conclusions or alternative approaches justified. This workshop report is considered a first step toward a revised GCCP 2.0.

  6. Good practices in Local Government - A first overview of Portuguese reality

    NASA Astrophysics Data System (ADS)

    Carvalhosa, P.; Portela, F.; Machado, J.; Santos, M. F.; Abelha, A.

    2017-03-01

    Good practices in eGov are being increasingly used by Local Governments being that it is considered by them as an advantage. The main goal is providing to the town hall a differentiation point and approximate their services to the citizens. For this, it is necessary to define and apply innovative strategies in order to increase the use of services by the citizens. This paper is framed in a research work and it presents a first overview of the existing good practices in eGov, taking in consideration the Portuguese’s reality. The good practices identified were distinguished with many awards and with a positive response from the target audience. The use of digital marketing strategies aims to increase their membership and coming closer the municipalities of its citizens through the dissemination of the good practices. At this moment the data collected are almost exclusively of good practice in Portugal, however some international practices were also identified. As a result of this study the community has a list of good practices that can be applied in their municipalities.

  7. Emerging Good Practices for Transforming Value Assessment: Patients' Voices, Patients' Values.

    PubMed

    Perfetto, Eleanor M; Harris, Jason; Mullins, C Daniel; dosReis, Susan

    2018-04-01

    Patient engagement is a transformative strategy for improving value assessment. US value framework developers have increased engagement activities, but more needs to be learned about how to best achieve meaningful patient engagement in value assessment. The objective was to glean good practices in patient engagement emerging from patient community experiences, to be used in value assessment. The National Health Council Value Workgroup conducted a survey and held a focus group with its member advocacy organizations to gather experiences with value framework developers and views on emerging good practices. Ten of 13 organizations completed the survey; reporting 13 interactions with four framework developers. Most rated experiences as "good" to "very good." Emerging good practices included (1) engage early; (2) engage a range of patients; (3) leverage patient-provided information, data resources, and outreach mechanisms; (4) be transparent; and (5) appreciate and accommodate resource constraints. Twelve of 13 organizations participated in the focus group, and this produced 30 emerging good practices in four areas: (1) timing; (2) methodology and data; (3) partnering; and (4) characterizing engagement. Patient engagement was limited in early development of value frameworks but has increased in the past few years. Patient groups report positive experiences that can serve as emerging good practices. These groups also reported experienced challenges in their interactions and recommended good practices to mitigate those challenges. The growing pool of patient engagement experiences can be translated into good practices to advance a patient-centered, value-driven health care ecosystem. Lessons learned from these early experiences can help establish recommend emerging good practices that can eventually result in best practices and standards in the field. Copyright © 2018 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc

  8. 75 FR 16345 - Administrative Practices and Procedures; Good Guidance Practices; Technical Amendment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-01

    .... FDA-1999-N-3539] (formerly Docket No. 1999N-4783) Administrative Practices and Procedures; Good Guidance Practices; Technical Amendment AGENCY: Food and Drug Administration, HHS. ACTION: Final rule... Subjects in 21 CFR Part 10 Administrative practice and procedure, News media. 0 Therefore, under the...

  9. Case studies of pre-engineered and manufactured sound isolation rooms for music practice and radio broadcast

    NASA Astrophysics Data System (ADS)

    Probst, Ron N.; Rypka, Dann

    2005-09-01

    Pre-engineered and manufactured sound isolation rooms were developed to ensure guaranteed sound isolation while offering the unique ability to be disassembled and relocated without loss of acoustic performance. Case studies of pre-engineered sound isolation rooms used for music practice and various radio broadcast purposes are highlighted. Three prominent universities wrestle with the challenges of growth and expansion while responding to the specialized acoustic requirements of these spaces. Reduced state funding for universities requires close examination of all options while ensuring sound isolation requirements are achieved. Changing curriculum, renovation, and new construction make pre-engineered and manufactured rooms with guaranteed acoustical performance good investments now and for the future. An added benefit is the optional integration of active acoustics to provide simulations of other spaces or venues along with the benefit of sound isolation.

  10. [Good drug distribution practice and its implementation in drug distribution companies].

    PubMed

    Draksiene, Gailute

    2002-01-01

    Good Distribution Practice is based on the Directive of the Board of the European Community 92/25/EEC regarding the wholesale distribution of drugs for human consumption. It is stated in the Directive that the whole drug distribution channel is to be controlled from the point of drug production or import down to the supplies to the end user. In order to reach the goal, the drug distribution company must create the quality assurance system and facilitate its correct functioning. This aim requires development of the rules of the Good Distribution Practice. Those rules set the general requirements of the Good Distribution Practice for distribution companies that they must conduct. The article explains main requirements postulated in the rules of the Good Distribution Practice and implementation of the Good Distribution Practice requirements in drug distribution companies.

  11. 75 FR 80011 - Good Laboratory Practice for Nonclinical Laboratory Studies

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-21

    ... for research or marketing permits for products regulated by FDA, including food and color additives, animal food additives, human and animal drugs, medical devices for human use, biological products, and... requested the ability to cite compliance with the applicable good manufacturing requirements (i.e, parts 210...

  12. Good practices in free-energy calculations.

    PubMed

    Pohorille, Andrew; Jarzynski, Christopher; Chipot, Christophe

    2010-08-19

    As access to computational resources continues to increase, free-energy calculations have emerged as a powerful tool that can play a predictive role in a wide range of research areas. Yet, the reliability of these calculations can often be improved significantly if a number of precepts, or good practices, are followed. Although the theory upon which these good practices rely has largely been known for many years, it is often overlooked or simply ignored. In other cases, the theoretical developments are too recent for their potential to be fully grasped and merged into popular platforms for the computation of free-energy differences. In this contribution, the current best practices for carrying out free-energy calculations using free energy perturbation and nonequilibrium work methods are discussed, demonstrating that at little to no additional cost, free-energy estimates could be markedly improved and bounded by meaningful error estimates. Monitoring the probability distributions that underlie the transformation between the states of interest, performing the calculation bidirectionally, stratifying the reaction pathway, and choosing the most appropriate paradigms and algorithms for transforming between states offer significant gains in both accuracy and precision.

  13. Good Laboratory Practice. Part 1. An Introduction

    ERIC Educational Resources Information Center

    Wedlich, Richard C.; Libera, Agata E.; Pires, Amanda; Therrien, Matthew T.

    2013-01-01

    The Good Laboratory Practice (GLP) regulations were put into place in 1978. They establish a standard of practice to ensure that results from the nonclinical laboratory study reported to the U.S. Food and Drug Administration (FDA) are valid and that the study report accurately reflects the conduct of the study. While the GLP regulations promulgate…

  14. Manufacturing waste disposal practices of the chemical propulsion industry

    NASA Technical Reports Server (NTRS)

    Goldberg, Benjamin E.; Adams, Daniel E.; Schutzenhofer, Scott A.

    1995-01-01

    The waste production, mitigation and disposal practices of the United States chemical propulsion industry have been investigated, delineated, and comparatively assessed to the U.S. industrial base. Special emphasis has been placed on examination of ozone depleting chemicals (ODC's). The research examines present and anticipated future practices and problems encountered in the manufacture of solid and liquid propulsion systems. Information collected includes current environmental laws and regulations that guide the industry practices, processes in which ODC's are or have been used, quantities of waste produced, funding required to maintain environmentally compliant practices, and preventive efforts.

  15. Protection of people and environment from radiation risk through good regulatory practice

    NASA Astrophysics Data System (ADS)

    Jais, Azlina Mohammad; Hassan, Najwa

    2017-01-01

    The term "good regulatory practice" has seen growing frequency of usage worldwide, especially since the 2011 Fukushima nuclear incident. However, the term appears quite ambiguous as it may mean differently to different people. This leads us to the first important question: what does "good regulatory practice" actually mean? When used in conjunction with the Fukushima incident, do we imply that there is an absence of "good regulatory practice" in the Japanese' Nuclear and Industry Safety Agency (NISA)? This is quite troubling. It is clear that the term should be defined formally so that our understanding of "good regulatory practice" can be standardized. There is still another important question beyond agreeing on what "good regulatory practice" is: is "good regulatory practice" specific to a region, or is it global? And is it applicable only to nuclear regulators, or to all types of regulators per se? This paper aims to deliberate on the above mentioned questions. Specifically, we hope to discuss the "good regulatory practice" for atomic energy activities in order to protect the people and the environment from radiation risk of such activities. By understanding what "good regulatory practice" truly means, a newcomer country such as Malaysia can quickly learn and adopt these practices so as to assure a competent national nuclear regulatory authority who will be responsible in ensuring the safety, security and safeguards of peaceful atomic energy activities in the country including nuclear liability. In understanding this concept, a holistic approach will be taken by looking into example of advanced and newcomer countries of various nuclear regulatory authorities all around the world. Then the paper will focus on the challenges that the current nuclear regulatory authority in Malaysia which is Atomic Energy Licensing Board has, its challenges to follow the concept of "good regulatory practice" and its ways to overcome it. This study explore the initiatives could be

  16. Do quality indicators for general practice teaching practices predict good outcomes for students?

    PubMed

    Bartlett, Maggie; Potts, Jessica; McKinley, Bob

    2016-07-01

    Keele medical students spend 113 days in general practices over our five-year programme. We collect practice data thought to indicate good quality teaching. We explored the relationships between these data and two outcomes for students; Objective Structured Clinical Examination (OSCE) scores and feedback regarding the placements. Though both are surrogate markers of good teaching, they are widely used. We collated practice and outcome data for one academic year. Two separate statistical analyses were carried out: (1) to determine how much of the variation seen in the OSCE scores was due to the effect of the practice and how much to the individual student. (2) to identify practice characteristics with a relationship to student feedback scores. (1) OSCE performance: 268 students in 90 practices: six quality indicators independently influenced the OSCE score, though without linear relationships and not to statistical significance. (2) Student satisfaction: 144 students in 69 practices: student feedback scores are not influenced by practice characteristics. The relationships between the quality indicators we collect for practices and outcomes for students are not clear. It may be that neither the quality indicators nor the outcome measures are reliable enough to inform decisions about practices' suitability for teaching.

  17. Understanding Graduate School Aspirations: The Effect of Good Teaching Practices

    ERIC Educational Resources Information Center

    Hanson, Jana M.; Paulsen, Michael B.; Pascarella, Ernest T.

    2016-01-01

    This study examined the effects of good teaching practices on post-baccalaureate degree aspirations using logistic regression techniques on a multi-institutional, longitudinal sample of students at 4-year colleges and universities in the USA. We examined whether eight good teaching practices (non-classroom interactions with faculty, prompt…

  18. 21 CFR 606.171 - Reporting of product deviations by licensed manufacturers, unlicensed registered blood...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... manufacturers, unlicensed registered blood establishments, and transfusion services. 606.171 Section 606.171...) BIOLOGICS CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS Records and Reports § 606.171 Reporting of product deviations by licensed manufacturers, unlicensed registered blood establishments, and...

  19. 21 CFR 606.171 - Reporting of product deviations by licensed manufacturers, unlicensed registered blood...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... manufacturers, unlicensed registered blood establishments, and transfusion services. 606.171 Section 606.171...) BIOLOGICS CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS Records and Reports § 606.171 Reporting of product deviations by licensed manufacturers, unlicensed registered blood establishments, and...

  20. 21 CFR 606.171 - Reporting of product deviations by licensed manufacturers, unlicensed registered blood...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... manufacturers, unlicensed registered blood establishments, and transfusion services. 606.171 Section 606.171...) BIOLOGICS CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS Records and Reports § 606.171 Reporting of product deviations by licensed manufacturers, unlicensed registered blood establishments, and...

  1. 21 CFR 606.171 - Reporting of product deviations by licensed manufacturers, unlicensed registered blood...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... manufacturers, unlicensed registered blood establishments, and transfusion services. 606.171 Section 606.171...) BIOLOGICS CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS Records and Reports § 606.171 Reporting of product deviations by licensed manufacturers, unlicensed registered blood establishments, and...

  2. 48 CFR 52.225-22 - Notice of Required Use of American Iron, Steel, and Manufactured Goods-Buy American Act...

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... American Iron, Steel, and Manufactured Goods-Buy American Act-Construction Materials. 52.225-22 Section 52... Required Use of American Iron, Steel, and Manufactured Goods—Buy American Act—Construction Materials. As prescribed in 25.1102(e), insert the following provision: Notice of Required Use of American Iron, Steel, and...

  3. 48 CFR 52.225-22 - Notice of Required Use of American Iron, Steel, and Manufactured Goods-Buy American Act...

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... American Iron, Steel, and Manufactured Goods-Buy American Act-Construction Materials. 52.225-22 Section 52... Required Use of American Iron, Steel, and Manufactured Goods—Buy American Act—Construction Materials. As prescribed in 25.1102(e), insert the following provision: Notice of Required Use of American Iron, Steel, and...

  4. 48 CFR 52.225-22 - Notice of Required Use of American Iron, Steel, and Manufactured Goods-Buy American Act...

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... American Iron, Steel, and Manufactured Goods-Buy American Act-Construction Materials. 52.225-22 Section 52... Required Use of American Iron, Steel, and Manufactured Goods—Buy American Act—Construction Materials. As prescribed in 25.1102(e), insert the following provision: Notice of Required Use of American Iron, Steel, and...

  5. 48 CFR 52.225-22 - Notice of Required Use of American Iron, Steel, and Manufactured Goods-Buy American Act...

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... American Iron, Steel, and Manufactured Goods-Buy American Act-Construction Materials. 52.225-22 Section 52... Required Use of American Iron, Steel, and Manufactured Goods—Buy American Act—Construction Materials. As prescribed in 25.1102(e), insert the following provision: Notice of Required Use of American Iron, Steel, and...

  6. Evaluation Instruments and Good Practices in Online Education

    ERIC Educational Resources Information Center

    Baldwin, Sally J.; Trespalacios, Jesús

    2017-01-01

    Chickering and Gamson's (1987) "Seven Principles for Good Practice in Undergraduate Education" offers extensively researched and validated tenets for best practices in higher education. After a review of the literature, twenty-eight evaluation instruments currently used to design and review online courses in higher education institutions…

  7. News: Good chemical manufacturing process criteria

    EPA Science Inventory

    This news column covers topics relating to manufacturing criteria, machine to machine technology, novel process windows, green chemistry indices, business resilience, immobilized enzymes, and Bt crops.

  8. Behavioral Patterns in Special Education. Good Teaching Practices.

    PubMed

    Rodríguez-Dorta, Manuela; Borges, África

    2017-01-01

    Providing quality education means to respond to the diversity in the classroom. The teacher is a key figure in responding to the various educational needs presented by students. Specifically, special education professionals are of great importance as they are the ones who lend their support to regular classroom teachers and offer specialized educational assistance to students who require it. Therefore, special education is different from what takes place in the regular classroom, demanding greater commitment by the teacher. There are certain behaviors, considered good teaching practices, which teachers have always been connected with to achieve good teaching and good learning. To ensure that these teachers are carrying out their educational work properly it is necessary to evaluate. This means having appropriate instruments. The Observational Protocol for Teaching Functions in Primary School and Special Education (PROFUNDO-EPE, v.3., in Spanish) allows to capture behaviors from these professionals and behavioral patterns that correspond to good teaching practices. This study evaluates the behavior of two special education teachers who work with students from different educational stages and educational needs. It reveals that the analyzed teachers adapt their behavior according the needs and characteristics of their students to the students responding more adequately to the needs presented by the students and showing good teaching practices. The patterns obtained indicate that they offer support, help and clear guidelines to perform the tasks. They motivate them toward learning by providing positive feedback and they check that students have properly assimilated the contents through questions or non-verbal supervision. Also, they provide a safe and reliable climate for learning.

  9. Licorice Production and Manufacturing: All-Sorts of Practical Applications for Statistics

    ERIC Educational Resources Information Center

    Watson, Jane; Skalicky, Jane; Fitzallen, Noleine; Wright, Suzie

    2009-01-01

    Among the practical applications of statistics is the collection of data from manufacturing processes. Often collected in the form of a time series, data collected from a series of measurements show the variation in those measurements, such as mass of a product manufactured. Limits are set for quality control and if these are exceeded then a…

  10. Good Practices in Free-energy Calculations

    NASA Technical Reports Server (NTRS)

    Pohorille, Andrew; Jarzynski, Christopher; Chipot, Christopher

    2013-01-01

    As access to computational resources continues to increase, free-energy calculations have emerged as a powerful tool that can play a predictive role in drug design. Yet, in a number of instances, the reliability of these calculations can be improved significantly if a number of precepts, or good practices are followed. For the most part, the theory upon which these good practices rely has been known for many years, but often overlooked, or simply ignored. In other cases, the theoretical developments are too recent for their potential to be fully grasped and merged into popular platforms for the computation of free-energy differences. The current best practices for carrying out free-energy calculations will be reviewed demonstrating that, at little to no additional cost, free-energy estimates could be markedly improved and bounded by meaningful error estimates. In energy perturbation and nonequilibrium work methods, monitoring the probability distributions that underlie the transformation between the states of interest, performing the calculation bidirectionally, stratifying the reaction pathway and choosing the most appropriate paradigms and algorithms for transforming between states offer significant gains in both accuracy and precision. In thermodynamic integration and probability distribution (histogramming) methods, properly designed adaptive techniques yield nearly uniform sampling of the relevant degrees of freedom and, by doing so, could markedly improve efficiency and accuracy of free energy calculations without incurring any additional computational expense.

  11. Current good tissue practice for human cell, tissue, and cellular and tissue-based product establishments; inspection and enforcement. Final rule.

    PubMed

    2004-11-24

    The Food and Drug Administration (FDA) is requiring human cell, tissue, and cellular and tissue-based product (HCT/P) establishments to follow current good tissue practice (CGTP), which governs the methods used in, and the facilities and controls used for, the manufacture of HCT/Ps; recordkeeping; and the establishment of a quality program. The agency is also issuing new regulations pertaining to labeling, reporting, inspections, and enforcement that will apply to manufacturers of those HCT/Ps regulated solely under the authority of the Public Health Service Act (PHS Act), and not as drugs, devices, and/or biological products. The agency's actions are intended to improve protection of the public health while keeping regulatory burden to a minimum, which in turn would encourage significant innovation.

  12. A robust, good manufacturing practice-compliant, clinical-scale procedure to generate regulatory T cells from patients with amyotrophic lateral sclerosis for adoptive cell therapy.

    PubMed

    Alsuliman, Abdullah; Appel, Stanley H; Beers, David R; Basar, Rafet; Shaim, Hila; Kaur, Indresh; Zulovich, Jane; Yvon, Eric; Muftuoglu, Muharrem; Imahashi, Nobuhiko; Kondo, Kayo; Liu, Enli; Shpall, Elizabeth J; Rezvani, Katayoun

    2016-10-01

    Regulatory T cells (Tregs) play a fundamental role in the maintenance of self-tolerance and immune homeostasis. Defects in Treg function and/or frequencies have been reported in multiple disease models. Amyotrophic lateral sclerosis (ALS) is a progressive neurodegenerative disorder affecting upper and lower motor neurons. Compelling evidence supports a neuroprotective role for Tregs in this disease. Indeed, rapid progression in ALS patients is associated with decreased FoxP3 expression and Treg frequencies. Thus, we propose that strategies to restore Treg number and function may slow disease progression in ALS. In this study, we developed a robust, Good Manufacturing Practice (GMP)-compliant procedure to enrich and expand Tregs from ALS patients. Tregs isolated from these patients were phenotypically similar to those from healthy individuals but were impaired in their ability to suppress T-cell effector function. In vitro expansion of Tregs for 4 weeks in the presence of GMP-grade anti-CD3/CD28 beads, interleukin (IL)-2 and rapamcyin resulted in a 25- to 200-fold increase in their number and restored their immunoregulatory activity. Collectively, our data facilitate and support the implementation of clinical trials of adoptive therapy with ex vivo expanded and highly suppressive Tregs in patients with ALS. Copyright © 2016 International Society for Cellular Therapy. Published by Elsevier Inc. All rights reserved.

  13. Editorial: A Note on Good Research Practice

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Dooley, James J.

    Good scientific practice and research misconduct have been concerns of mine for more than a decade (Dooley and Kerch, 2000) and in my role as an editor of the International Journal of Greenhouse Gas Control, I feel it is time to speak up and at the very least share my concerns and suggestions as they relate to the integrity of the research published in this journal. Rather than wait to write an editorial on good research practices in response to a major incident, I thought it might be best to be proactive and address some of the trends we seemore » in submissions to this peer reviewed journal and to offer some suggestions for improvement improving the level of scholarship in some – but by no means all – of the papers submitted.« less

  14. Behavioral Patterns in Special Education. Good Teaching Practices

    PubMed Central

    Rodríguez-Dorta, Manuela; Borges, África

    2017-01-01

    Providing quality education means to respond to the diversity in the classroom. The teacher is a key figure in responding to the various educational needs presented by students. Specifically, special education professionals are of great importance as they are the ones who lend their support to regular classroom teachers and offer specialized educational assistance to students who require it. Therefore, special education is different from what takes place in the regular classroom, demanding greater commitment by the teacher. There are certain behaviors, considered good teaching practices, which teachers have always been connected with to achieve good teaching and good learning. To ensure that these teachers are carrying out their educational work properly it is necessary to evaluate. This means having appropriate instruments. The Observational Protocol for Teaching Functions in Primary School and Special Education (PROFUNDO-EPE, v.3., in Spanish) allows to capture behaviors from these professionals and behavioral patterns that correspond to good teaching practices. This study evaluates the behavior of two special education teachers who work with students from different educational stages and educational needs. It reveals that the analyzed teachers adapt their behavior according the needs and characteristics of their students to the students responding more adequately to the needs presented by the students and showing good teaching practices. The patterns obtained indicate that they offer support, help and clear guidelines to perform the tasks. They motivate them toward learning by providing positive feedback and they check that students have properly assimilated the contents through questions or non-verbal supervision. Also, they provide a safe and reliable climate for learning. PMID:28512437

  15. Project-Based Manufacturing Engineering Practice at Ibaraki University and Its Outcomes

    NASA Astrophysics Data System (ADS)

    Yamasaki, Kazuhiko; Wang, Dong F.; Maekawa, Katsuhiro

    The real world experience of manufacturing processes from an idea stage to a final product must be related to classroom lectures in mechanical engineering curriculum, including design, materials engineering, dynamics and control. Various challenges and difficulties encountered during the manufacturing engineering practice also let students recognize their creativity as well as what kinds of knowledge is missing. Awareness is the start of growth. In line with this principle we have carried out the mechanical engineering practice for 10 years. Some modifications toward “project-based practice” , however, have been made through manufacturing engineers’ real activities. Drawing and specification, process control, cost management, and role-sharing arrangement are stressed during the semester course. The present paper describes how it works and what is left to improve further, such as a refinement of themes and a coaching method for bringing out the hidden talent in students.

  16. Robust data enables managers to promote good practice.

    PubMed

    Bassett, Sally; Westmore, Kathryn

    2012-11-01

    This is the third in a series of articles examining the components of good corporate governance. The effective and efficient use of information and sources of information is crucial for good governance. This article explores the ways in which boards and management can obtain and use information to monitor performance and promote good practice, and how boards can be assured about the quality of information on which they rely. The final article in this series will look at the role of accountability in corporate governance.

  17. The implementation of tissue banking experiences for setting up a cGMP cell manufacturing facility.

    PubMed

    Arjmand, Babak; Emami-Razavi, Seyed Hassan; Larijani, Bagher; Norouzi-Javidan, Abbas; Aghayan, Hamid Reza

    2012-12-01

    Cell manufacturing for clinical applications is a unique form of biologics manufacturing that relies on maintenance of stringent work practices designed to ensure product consistency and prevent contamination by microorganisms or by another patient's cells. More extensive, prolonged laboratory processes involve greater risk of complications and possibly adverse events for the recipient, and so the need for control is correspondingly greater. To minimize the associate risks of cell manufacturing adhering to international quality standards is critical. Current good tissue practice (cGTP) and current good manufacturing practice (cGMP) are examples of general standards that draw a baseline for cell manufacturing facilities. In recent years, stem cell researches have found great public interest in Iran and different cell therapy projects have been started in country. In this review we described the role of our tissue banking experiences in establishing a new cGMP cell manufacturing facility. The authors concluded that, tissue banks and tissue banking experts can broaden their roles from preparing tissue grafts to manufacturing cell and tissue engineered products for translational researches and phase I clinical trials. Also they can collaborate with cell processing laboratories to develop SOPs, implement quality management system, and design cGMP facilities.

  18. Alternative Pathways to Apprenticeships. Good Practice Guide

    ERIC Educational Resources Information Center

    National Centre for Vocational Education Research (NCVER), 2015

    2015-01-01

    Apprenticeships are changing. The increasing proportions of people entering apprenticeships at various levels of ability and backgrounds are stimulating demand for alternative pathways to completions. This good practice guide assembles the key findings for education practitioners and workplace supervisors from three related research reports on…

  19. Modeling study of air pollution due to the manufacture of export goods in China's Pearl River Delta.

    PubMed

    Streets, David G; Yu, Carolyne; Bergin, Michael H; Wang, Xuemei; Carmichael, Gregory R

    2006-04-01

    The Pearl River Delta is a major manufacturing region on the south coast of China that produces more than dollar 100 billion of goods annually for export to North America, Europe, and other parts of Asia. Considerable air pollution is caused by the manufacturing industries themselves and by the power plants, trucks, and ships that support them. We estimate that 10-40% of emissions of primary SO2, NO(x), RSP, and VOC in the region are caused by export-related activities. Using the STEM-2K1 atmospheric transport model, we estimate that these emissions contribute 5-30% of the ambient concentrations of SO2, NO(x), NO(z), and VOC in the region. One reason that the exported goods are cheap and therefore attractive to consumers in developed countries is that emission controls are lacking or of low performance. We estimate that state-of-the-art controls could be installed at an annualized cost of dollar 0.3-3 billion, representing 0.3-3% of the value of the goods produced. We conclude that mitigation measures could be adopted without seriously affecting the prices of exported goods and would achieve considerable human health and other benefits in the form of reduced air pollutant concentrations in densely populated urban areas.

  20. 47 CFR 73.508 - Standards of good engineering practice.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 47 Telecommunication 4 2010-10-01 2010-10-01 false Standards of good engineering practice. 73.508 Section 73.508 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) BROADCAST RADIO SERVICES... engineering practice. (a) All noncommercial educational stations and LPFM stations operating with more than 10...

  1. 47 CFR 73.508 - Standards of good engineering practice.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 47 Telecommunication 4 2014-10-01 2014-10-01 false Standards of good engineering practice. 73.508 Section 73.508 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) BROADCAST RADIO SERVICES... engineering practice. (a) All noncommercial educational stations and LPFM stations operating with more than 10...

  2. 47 CFR 73.508 - Standards of good engineering practice.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 47 Telecommunication 4 2012-10-01 2012-10-01 false Standards of good engineering practice. 73.508 Section 73.508 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) BROADCAST RADIO SERVICES... engineering practice. (a) All noncommercial educational stations and LPFM stations operating with more than 10...

  3. 47 CFR 73.508 - Standards of good engineering practice.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 47 Telecommunication 4 2013-10-01 2013-10-01 false Standards of good engineering practice. 73.508 Section 73.508 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) BROADCAST RADIO SERVICES... engineering practice. (a) All noncommercial educational stations and LPFM stations operating with more than 10...

  4. 47 CFR 73.508 - Standards of good engineering practice.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 47 Telecommunication 4 2011-10-01 2011-10-01 false Standards of good engineering practice. 73.508 Section 73.508 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) BROADCAST RADIO SERVICES... engineering practice. (a) All noncommercial educational stations and LPFM stations operating with more than 10...

  5. Improving nutritional care: innovation and good practice.

    PubMed

    Chapman, Carol; Barker, Mary; Lawrence, Wendy

    2015-04-01

    This paper presents examples of good practice in nutritional screening and care and identifies methods used to overcome contextual constraints and discusses the implications for nursing practice in hospitals. Nutritional screening is an important step in identifying those at risk of malnutrition, but does not produce improved nutritional care unless it results in a care plan that is acted on. The importance of nutrition and implications for clinical care make it imperative to improve practice. Qualitative investigation. Between January 2011-February 2012, focus groups were held using a semi-structured discussion guide with nine groups of health professionals (n = 80) from one hospital: four with nurses, three with doctors and two with dietitians. Discussions were audio-recorded, transcribed and coded into themes and sub-themes, which were then depicted in a thematic map and illustrated with verbatim quotes. Three strategies for sustaining effective nutritional practice emerged: establishing routines to ensure screening was undertaken; re-organizing aspects of care to promote good practice; developing innovative approaches. Issues to be addressed were the perceived disconnection between mandatory screening and the delivery of effective care, a requirement for nutrition education, organizational constraints of a large university hospital and the complexities of multidisciplinary working. Professionals seeking to improve nutritional care in hospitals need to understand the interaction of system and person to facilitate change. Nursing staff need to be able to exercise autonomy and the hospital system must offer enough flexibility to allow wards to organize nutritional screening and care in a way that meets the needs of individual patients. © 2014 John Wiley & Sons Ltd.

  6. Good enough practices in scientific computing.

    PubMed

    Wilson, Greg; Bryan, Jennifer; Cranston, Karen; Kitzes, Justin; Nederbragt, Lex; Teal, Tracy K

    2017-06-01

    Computers are now essential in all branches of science, but most researchers are never taught the equivalent of basic lab skills for research computing. As a result, data can get lost, analyses can take much longer than necessary, and researchers are limited in how effectively they can work with software and data. Computing workflows need to follow the same practices as lab projects and notebooks, with organized data, documented steps, and the project structured for reproducibility, but researchers new to computing often don't know where to start. This paper presents a set of good computing practices that every researcher can adopt, regardless of their current level of computational skill. These practices, which encompass data management, programming, collaborating with colleagues, organizing projects, tracking work, and writing manuscripts, are drawn from a wide variety of published sources from our daily lives and from our work with volunteer organizations that have delivered workshops to over 11,000 people since 2010.

  7. Use of digital technologies for nasal prosthesis manufacturing.

    PubMed

    Palousek, David; Rosicky, Jiri; Koutny, Daniel

    2014-04-01

    Digital technology is becoming more accessible for common use in medical applications; however, their expansion in prosthetic and orthotic laboratories is not large because of the persistent image of difficult applicability to real patients. This article aims to offer real example in the area of human facial prostheses. This article describes the utilization of optical digitization, computational modelling, rapid prototyping, mould fabrication and manufacturing of a nasal silicone prosthesis. This technical note defines the key points of the methodology and aspires to contribute to the introduction of a certified manufacturing procedure. The results show that the used technologies reduce the manufacturing time, reflect patient's requirements and allow the manufacture of high-quality prostheses for missing facial asymmetric parts. The methodology provides a good position for further development issues and is usable for clinical practice. Clinical relevance Utilization of digital technologies in facial prosthesis manufacturing process can be a good contribution for higher patient comfort and higher production efficiency but with higher initial investment and demands for experience with software tools.

  8. Tourism. Leonardo da Vinci Series: Good Practices.

    ERIC Educational Resources Information Center

    Commission of the European Communities, Brussels (Belgium). Directorate-General for Education and Culture.

    This brochure, part of a series about good practices in vocational training in the European Union, describes 10 projects that have promoted investment in human resources through training in the tourism sector to promote sustainable, or responsible, tourism. The projects and their countries of origin are as follows: (1) BEEFT, training of mobility…

  9. Practical Education Support to Foster Engineers at Manufacturing and Engineering Design Center in Muroran Institute of Technology

    NASA Astrophysics Data System (ADS)

    Kazama, Toshiharu; Hanajima, Naohiko; Shimizu, Kazumichi; Satoh, Kohki

    To foster engineers with creative power, Muroran Institute of Technology established Manufacturing and Engineering Design Center (MEDeC) that concentrates on Monozukuri. MEDeC consists of three project groups : i) Education Support Group provides educational support for practical training classes on and off campus and PDCA (plan-do-check-action) -conscious engineering design education related to Monozukuri ; ii) Fundamental Manufacturing Research Group carries out nurture research into fundamental and innovative technology of machining and manufacturing, and iii) Regional Cooperation Group coordinates the activities in cooperation with bureau, schools and industries in and around Muroran City. MEDeC has a fully integrated collection of machine tools and hand tools for manufacturing, an atelier, a tatara workplace, implements for measurement and related equipment designed for practically teaching state-of-the-practice manufacturing methods.

  10. Good Policy, Good Practice II. Improving Outcomes and Productivity in Higher Education: A Guide for Policymakers

    ERIC Educational Resources Information Center

    Brenneman, Meghan Wilson; Callan, Patrick M.; Ewell, Peter T.; Finney, Joni E.; Jones, Dennis P.; Zis, Stacey

    2010-01-01

    This new edition of "Good Policy, Good Practice II" revises and updates the authors' 2007 publication. Like the earlier edition, it responds to one of the questions that is raised most frequently in the authors' work with public policy and education leaders as they begin to address the national and state imperatives to increase the proportion of…

  11. Precision manufacturing for clinical-quality regenerative medicines.

    PubMed

    Williams, David J; Thomas, Robert J; Hourd, Paul C; Chandra, Amit; Ratcliffe, Elizabeth; Liu, Yang; Rayment, Erin A; Archer, J Richard

    2012-08-28

    Innovations in engineering applied to healthcare make a significant difference to people's lives. Market growth is guaranteed by demographics. Regulation and requirements for good manufacturing practice-extreme levels of repeatability and reliability-demand high-precision process and measurement solutions. Emerging technologies using living biological materials add complexity. This paper presents some results of work demonstrating the precision automated manufacture of living materials, particularly the expansion of populations of human stem cells for therapeutic use as regenerative medicines. The paper also describes quality engineering techniques for precision process design and improvement, and identifies the requirements for manufacturing technology and measurement systems evolution for such therapies.

  12. [Identification of Good-Practice Projects in Promoting Physical Activity - Methods, Pitfalls and Sampled Outcomes].

    PubMed

    Henn, Annette; Karger, Claudia; Wöhlken, Katrin; Meier, Diana; Ungerer-Röhrich, Ulrike; Graf, Christine; Woll, Alexander

    2017-03-01

    The aim of this paper is to identify and show examples of good practice of public health promotion. For this, uniform quality criteria were worked out under consideration of national and international scientific literature.For the identification of examples of good practice, a comparison of different quality criteria was carried out and combined with each other in a first step. In the following step, examples of good practice were identified after a comprehensive search. The choice of the "good-practice" projects is exemplary and lays no claim to completeness.6 main quality criteria (QC) of programs promoting physical activity could be identified in the national and international context. The analysis showed altogether 10 projects which can exemplarily be classified as examples of good practice of the target groups of children and teenagers, adults, older people and people with pre-existing illnesses. These projects, however, show major differences in their (methodological) quality.The analysis reports a lack of "Good-Practice" examples. Deficits lie mainly in documentation and sustainability. Because of incomplete documentation, an assessment as a "Good-Practice" example is only possible to a limited extent; a lot of information, particularly in the evaluation, is missing. © Georg Thieme Verlag KG Stuttgart · New York.

  13. Principles of Good Practice in SoTL

    ERIC Educational Resources Information Center

    Felten, Peter

    2013-01-01

    For the Scholarship of Teaching and Learning (SoTL) to be understood as significant intellectual work in the academy, SoTL practitioners need to identify shared principles of good practice. While honoring the diversity of SoTL in its many forms across the globe, such principles can serve as a heuristic for assessing work in our field. These…

  14. Investigating School-Wide Antecedents of Good Practice Dissemination from Individual Subject Projects

    ERIC Educational Resources Information Center

    Christophersen, Knut-Andreas; Elstad, Eyvind; Turmo, Are

    2012-01-01

    Good practice dissemination is an unsolved problem in education. This article describes how clear and "soft" leadership and perceptions of social and economic exchange operate in the bottom-up processes of school reforms and examines the relative impact of these factors on school-wide good practice dissemination and discusses how…

  15. The Conditional Nature of High Impact/Good Practices on Student Learning Outcomes

    ERIC Educational Resources Information Center

    Seifert, Tricia A.; Gillig, Benjamin; Hanson, Jana M.; Pascarella, Ernest T.; Blaich, Charles F.

    2014-01-01

    Using a multi-institutional sample of undergraduate students, this study found that the relationships between engaging in high impact/good practices and liberal arts outcomes differ based on students' precollege and background characteristics. Findings suggest that high impact/good practices are not a panacea and require a greater degree of…

  16. Emergency management training program: Guide to good practice

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Not Available

    1991-07-01

    The Emergency Management Training Program Guide to Good Practice is a project of the Training Resources and Data Exchange (TRADE) Emergency Management Issues Special Interest Group (EMI SIG). EMI SIG members expressed interest in a resource to assist in development of a comprehensive emergency management training program. This publication provides guidelines, methods, and materials for EMI SIG members to use, assisting in complete and effective emergency management programs. The purposes of the Emergency Management Training Program Guide to Good Practice are: Provide guidance in the development and management of Emergency Management (EM) training programs; Assist EM trainers to incorporate componentsmore » of the DOE Emergency Management System philosophy of planning, preparedness, readiness assurance, and response into EM training programs; Help EM training managers meet EM training requirements and conditions established by current regulations and policies; Supplement other TRADE EMI SIG documents and complement individual facility training documents. This program is designed for emergency management personnel who are responsible for providing or overseeing EM training but who do not necessarily possess expertise in developing training. It provides good practices from the manager's point of view on how to produce, administer, and document facility EM training programs in the spirit of the DOE EM system philosophy. Basic guidance is also included for personnel who design, develop, deliver, and/or evaluate EM training programs or parts. This guidance includes key points of EM training programs and identifies other documents that contain useful and/or more detailed training information.« less

  17. Emergency management training program: Guide to good practice

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Not Available

    1991-07-01

    The Emergency Management Training Program Guide to Good Practice is a project of the Training Resources and Data Exchange (TRADE) Emergency Management Issues Special Interest Group (EMI SIG). EMI SIG members expressed interest in a resource to assist in development of a comprehensive emergency management training program. This publication provides guidelines, methods, and materials for EMI SIG members to use, assisting in complete and effective emergency management programs. The purposes of the Emergency Management Training Program Guide to Good Practice are: Provide guidance in the development and management of Emergency Management (EM) training programs; Assist EM trainers to incorporate componentsmore » of the DOE Emergency Management System philosophy of planning, preparedness, readiness assurance, and response into EM training programs; Help EM training managers meet EM training requirements and conditions established by current regulations and policies; Supplement other TRADE EMI SIG documents and complement individual facility training documents. This program is designed for emergency management personnel who are responsible for providing or overseeing EM training but who do not necessarily possess expertise in developing training. It provides good practices from the manager`s point of view on how to produce, administer, and document facility EM training programs in the spirit of the DOE EM system philosophy. Basic guidance is also included for personnel who design, develop, deliver, and/or evaluate EM training programs or parts. This guidance includes key points of EM training programs and identifies other documents that contain useful and/or more detailed training information.« less

  18. Nursing practice: compassionate deception and the Good Samaritan.

    PubMed

    Tuckett, A

    1999-09-01

    This article reviews the literature on deception to illuminate the phenomenon as a background for an appraisal within nursing. It then describes nursing as a practice of caring. The character of the Good Samaritan is recommended as indicative of the virtue of compassion that ought to underpin caring in nursing practice. Finally, the article concludes that a caring nurse, responding virtuously, acts by being compassionate, for a time recognizing the prima facie nature of the rules or principles of truth telling.

  19. Management Documentation: Indicators & Good Practice at Cultural Heritage Places

    NASA Astrophysics Data System (ADS)

    Eppich, R.; Garcia Grinda, J. L.

    2015-08-01

    Documentation for cultural heritage places usually refers to describing the physical attributes, surrounding context, condition or environment; most of the time with images, graphics, maps or digital 3D models in their various forms with supporting textural information. Just as important as this type of information is the documentation of managerial attributes. How do managers of cultural heritage places collect information related to financial or economic well-being? How are data collected over time measured, and what are significant indicators for improvement? What quality of indicator is good enough? Good management of cultural heritage places is essential for conservation longevity, preservation of values and enjoyment by the public. But how is management documented? The paper will describe the research methodology, selection and description of attributes or indicators related to good management practice. It will describe the criteria for indicator selection and why they are important, how and when they are collected, by whom, and the difficulties in obtaining this information. As importantly it will describe how this type of documentation directly contributes to improving conservation practice. Good practice summaries will be presented that highlight this type of documentation including Pamplona and Ávila, Spain and Valletta, Malta. Conclusions are drawn with preliminary recommendations for improvement of this important aspect of documentation. Documentation of this nature is not typical and presents a unique challenge to collect, measure and communicate easily. However, it is an essential category that is often ignored yet absolutely essential in order to conserve cultural heritage places.

  20. Stable and non-competitive association of Saccharomyces cerevisiae, Candida milleri and Lactobacillus sanfranciscensis during manufacture of two traditional sourdough baked goods.

    PubMed

    Venturi, Manuel; Guerrini, Simona; Vincenzini, Massimo

    2012-08-01

    The microbiota occurring in all the manufacturing phases of two Italian sourdough sweet-leavened baked goods (a typical Genoese dry biscuit, Lagaccio, and a soft stuffed North Italian typical cake, Panettone) were investigated over a period of three years. The two sourdough mother sponges were characterized by the stable presence of three dominant microbial species in potential competition for carbohydrates: Lactobacillus sanfranciscensis, Candida milleri, and Saccharomyces cerevisiae. Genotypic and phenotypic characterizations of microbial isolates pointed out that each mother sponge harbored its own strains, well distinguishable by molecular methods of analysis but not differing in their main metabolic properties from those known for the corresponding species. The microbial and biochemical evolution during the whole production protocol of both manufactures demonstrated that the three microbial species grew at almost the same growth rates, without exhausting any of the main carbon substrates (maltose, glucose and fructose). The quite similar growth dynamics under practical conditions and the constant presence of all fermentable carbohydrates were recognized as responsible for the stable non competitive association of maltose-positive and maltose-negative species in both sourdoughs. However, the two sourdoughs were characterized by quite different LAB to yeast ratio, with values significantly higher in Panettone than in Lagaccio. The cause of this difference could mainly be ascribed to the temperature of the mother sponge regeneration phase, that, in the case of Panettone manufacture, occurred under conditions of moderate refrigeration. Copyright © 2012 Elsevier Ltd. All rights reserved.

  1. "Inclusive Working Life" in Norway--experience from "Models of Good Practice" enterprises.

    PubMed

    Lie, Arve

    2008-08-01

    To determine whether enterprises belonging to the Bank of Models of Good Practice were more successful than average Norwegian enterprises in the reduction of sickness absence, promotion of early return to work, and prevention of early retirement. In 2004 we selected 86 enterprises with a total of approximately 90000 employees from the Inclusive Working Life (IWL) Bank of Models of Good Practice. One representative of workers and one of management from each enterprise received a questionnaire on the aims, organization, and the results of the IWL program by mail. Data on sickness absence, use of early retirement, and disability retirement in the 2000-2004 period were collected from the National Insurance Registry. Data on comparable enterprises were obtained from the National Bureau of Statistics. The response rate was 65%. Although the IWL campaign was directed at reducing sickness absence, preventing early retirement, and promoting employment of the functionally impaired, most attention was paid to reducing sickness absence. Sickness absence rate in Models of Good Practice enterprises (8.2%) was higher than in comparable enterprises that were not part of the Models of Good Practice (6.9%). Implementation of many IWL activities, empowerment and involvement of employees, and good cooperation with the occupational health service were associated with a lower rate of sickness absence. On average, 0.7% new employees per year received disability pension, which is a significantly lower percentage than expected on the basis of the rate of 1.3% per year in comparable enterprises. Frequent use of disability pensioning was associated with high rate of sickness absence and having many employees older than 50 years. On average, 0.4% employees per year received early retirement compensation, which was expected on the basis of national estimates. Frequent use of early retirement was associated with having many employees older than 50 years. Models of Good Practice enterprises had

  2. Good practices for quantitative bias analysis.

    PubMed

    Lash, Timothy L; Fox, Matthew P; MacLehose, Richard F; Maldonado, George; McCandless, Lawrence C; Greenland, Sander

    2014-12-01

    Quantitative bias analysis serves several objectives in epidemiological research. First, it provides a quantitative estimate of the direction, magnitude and uncertainty arising from systematic errors. Second, the acts of identifying sources of systematic error, writing down models to quantify them, assigning values to the bias parameters and interpreting the results combat the human tendency towards overconfidence in research results, syntheses and critiques and the inferences that rest upon them. Finally, by suggesting aspects that dominate uncertainty in a particular research result or topic area, bias analysis can guide efficient allocation of sparse research resources. The fundamental methods of bias analyses have been known for decades, and there have been calls for more widespread use for nearly as long. There was a time when some believed that bias analyses were rarely undertaken because the methods were not widely known and because automated computing tools were not readily available to implement the methods. These shortcomings have been largely resolved. We must, therefore, contemplate other barriers to implementation. One possibility is that practitioners avoid the analyses because they lack confidence in the practice of bias analysis. The purpose of this paper is therefore to describe what we view as good practices for applying quantitative bias analysis to epidemiological data, directed towards those familiar with the methods. We focus on answering questions often posed to those of us who advocate incorporation of bias analysis methods into teaching and research. These include the following. When is bias analysis practical and productive? How does one select the biases that ought to be addressed? How does one select a method to model biases? How does one assign values to the parameters of a bias model? How does one present and interpret a bias analysis?. We hope that our guide to good practices for conducting and presenting bias analyses will encourage

  3. A practical approach for the validation of sterility, endotoxin and potency testing of bone marrow mononucleated cells used in cardiac regeneration in compliance with good manufacturing practice.

    PubMed

    Soncin, Sabrina; Lo Cicero, Viviana; Astori, Giuseppe; Soldati, Gianni; Gola, Mauro; Sürder, Daniel; Moccetti, Tiziano

    2009-09-08

    Main scope of the EU and FDA regulations is to establish a classification criterion for advanced therapy medicinal products (ATMP). Regulations require that ATMPs must be prepared under good manufacturing practice (GMP). We have validated a commercial system for the determination of bacterial endotoxins in compliance with EU Pharmacopoeia 2.6.14, the sterility testing in compliance with EU Pharmacopoeia 2.6.1 and a potency assay in an ATMP constituted of mononucleated cells used in cardiac regeneration. For the potency assay, cells were placed in the upper part of a modified Boyden chamber containing Endocult Basal Medium with supplements and transmigrated cells were scored. The invasion index was expressed as the ratio between the numbers of invading cells relative to cell migration through a control insert membrane. For endotoxins, we used a commercially available system based on the kinetic chromogenic LAL-test. Validation of sterility was performed by direct inoculation of TSB and FTM media with the cell product following Eu Ph 2.6.1 guideline. The calculated MVD and endotoxin limit were 780x and 39 EU/ml respectively. The 1:10 and 1:100 dilutions were selected for the validation. For sterility, all the FTM cultures were positive after 3 days. For TSB cultures, Mycetes and B. subtilis were positive after 5 and 3 days respectively. The detection limit was 1-10 colonies. A total of four invasion assay were performed: the calculated invasion index was 28.89 +/- 16.82% (mean +/- SD). We have validated a strategy for endotoxin, sterility and potency testing in an ATMP used in cardiac regeneration. Unlike pharmaceutical products, many stem-cell-based products may originate in hospitals where personnel are unfamiliar with the applicable regulations. As new ATMPs are developed, the regulatory framework is likely to evolve. Meanwhile, existing regulations provide an appropriate structure for ensuring the safety and efficacy of the next generation of ATMPs. Personnel

  4. 21 CFR 111.205 - What is the requirement to establish a master manufacturing record?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 2 2012-04-01 2012-04-01 false What is the requirement to establish a master manufacturing record? 111.205 Section 111.205 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN...

  5. 21 CFR 111.205 - What is the requirement to establish a master manufacturing record?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 2 2011-04-01 2011-04-01 false What is the requirement to establish a master manufacturing record? 111.205 Section 111.205 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN...

  6. Changing Public Perception in Wisconsin: Manufacturing a "Good Life"

    ERIC Educational Resources Information Center

    Jorgensen, Haley

    2006-01-01

    Careers in manufacturing are high-wage and high-tech. Yet, a future workforce shortage may be on the horizon. It appears a negative public perception--one that brings to mind low wages, assembly-line work and lay-offs--is thwarting young adults from pursuing manufacturing careers across the country. This article describes how the Wisconsin…

  7. 78 FR 22887 - Guidance for Industry on Non-Penicillin Beta-Lactam Drugs: A Current Good Manufacturing Practices...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-17

    ... for Preventing Cross- Contamination; Availability AGENCY: Food and Drug Administration, HHS. ACTION... require separation of manufacturing facilities to avoid cross-contamination, the only class of products... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0104...

  8. Optimization Manufacture of Virus- and Tumor-Specific T Cells

    PubMed Central

    Lapteva, Natalia; Vera, Juan F.

    2011-01-01

    Although ex vivo expanded T cells are currently widely used in pre-clinical and clinical trials, the complexity of manufacture remains a major impediment for broader application. In this review we discuss current protocols for the ex vivo expansion of virus- and tumor-specific T cells and describe our experience in manufacture optimization using a gas-permeable static culture flask (G-Rex). This innovative device has revolutionized the manufacture process by allowing us to increase cell yields while decreasing the frequency of cell manipulation and in vitro culture time. It is now being used in good manufacturing practice (GMP) facilities for clinical cell production in our institution as well as many others in the US and worldwide. PMID:21915183

  9. ASSESSMENT OF GOOD PRACTICES IN HOSPITAL FOOD SERVICE BY COMPARING EVALUATION TOOLS.

    PubMed

    Macedo Gonçalves, Juliana; Lameiro Rodrigues, Kelly; Santiago Almeida, Ângela Teresinha; Pereira, Giselda Maria; Duarte Buchweitz, Márcia Rúbia

    2015-10-01

    since food service in hospitals complements medical treatment, it should be produced in proper hygienic and sanitary conditions. It is a well-known fact that food-transmitted illnesses affect with greater severity hospitalized and immunosuppressed patients. good practices in hospital food service are evaluated by comparing assessment instruments. good practices were evaluated by a verification list following Resolution of Collegiate Directory n. 216 of the Brazilian Agency for Sanitary Vigilance. Interpretation of listed items followed parameters of RCD 216 and the Brazilian Association of Collective Meals Enterprises (BACME). Fisher's exact test was applied to detect whether there were statistically significant differences. Analysis of data grouping was undertaken with Unweighted Pair-group using Arithmetic Averages, coupled to a correlation study between dissimilarity matrixes to verify disagreement between the two methods. Good Practice was classified with mean total rates above 75% by the two methods. There were statistically significant differences between services and food evaluated by BACME instrument. Hospital Food Services have proved to show conditions of acceptable good practices. the comparison of interpretation tools based on RCD n. 216 and BACME provided similar results for the two classifications. Copyright AULA MEDICA EDICIONES 2014. Published by AULA MEDICA. All rights reserved.

  10. Good practices : incorporating safety into resurfacing and restoration projects

    DOT National Transportation Integrated Search

    2006-12-01

    Integrating safety improvements into resurfacing and restoration projects is a subject of long-standing interest by Federal, State, and local transportation agencies. A Scan Tour was conducted to identify and subsequently observe good practices in th...

  11. Good Practice in GNVQ Induction Programmes. Project Report.

    ERIC Educational Resources Information Center

    Benett, Yves

    A 2-year research and development project was conducted to identify existing good practices for introducing students in the United Kingdom (UK) to General National Vocational Qualifications (GNVQs) and available teaching and learning materials for use in the induction of GNVQs in UK schools and colleges. The main activities of the project's three…

  12. GUIDING PRINCIPLES FOR GOOD PRACTICES IN HOSPITAL-BASED HEALTH TECHNOLOGY ASSESSMENT UNITS.

    PubMed

    Sampietro-Colom, Laura; Lach, Krzysztof; Pasternack, Iris; Wasserfallen, Jean-Blaise; Cicchetti, Americo; Marchetti, Marco; Kidholm, Kristian; Arentz-Hansen, Helene; Rosenmöller, Magdalene; Wild, Claudia; Kahveci, Rabia; Ulst, Margus

    2015-01-01

    Health technology assessment (HTA) carried out for policy decision making has well-established principles unlike hospital-based HTA (HB-HTA), which differs from the former in the context characteristics and ways of operation. This study proposes principles for good practices in HB-HTA units. A framework for good practice criteria was built inspired by the EFQM excellence business model and information from six literature reviews, 107 face-to-face interviews, forty case studies, large-scale survey, focus group, Delphi survey, as well as local and international validation. In total, 385 people from twenty countries have participated in defining the principles for good practices in HB-HTA units. Fifteen guiding principles for good practices in HB-HTA units are grouped in four dimensions. Dimension 1 deals with principles of the assessment process aimed at providing contextualized information for hospital decision makers. Dimension 2 describes leadership, strategy and partnerships of HB-HTA units which govern and facilitate the assessment process. Dimension 3 focuses on adequate resources that ensure the operation of HB-HTA units. Dimension 4 deals with measuring the short- and long-term impact of the overall performance of HB-HTA units. Finally, nine core guiding principles were selected as essential requirements for HB-HTA units based on the expertise of the HB-HTA units participating in the project. Guiding principles for good practices set up a benchmark for HB-HTA because they represent the ideal performance of HB-HTA units; nevertheless, when performing HTA at hospital level, context also matters; therefore, they should be adapted to ensure their applicability in the local context.

  13. Guide to good practices for operations and administration updates through required reading

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Not Available

    1992-12-01

    The purpose of this Guide to Good Practices is to provide Department of Energy (DOE) contractors with information that can be used to validate and/or modify existing programs relative to Conduct of Operations. This Guide to Good Practices is part of a series of guides designed to enhance the guidelines set forth in DOE Order 5480. 19, Conduct of Operations Requirements for DOE Facilities.'' (JDB)

  14. Guide to good practices for operations and administration updates through required reading

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Not Available

    1992-12-01

    The purpose of this Guide to Good Practices is to provide Department of Energy (DOE) contractors with information that can be used to validate and/or modify existing programs relative to Conduct of Operations. This Guide to Good Practices is part of a series of guides designed to enhance the guidelines set forth in DOE Order 5480. 19, ``Conduct of Operations Requirements for DOE Facilities.`` (JDB)

  15. Electronic business model for small- and medium-sized manufacturing enterprises (SME): a case study

    NASA Astrophysics Data System (ADS)

    Yuen, Karina; Chung, Walter W.

    2001-10-01

    This paper identifies three essential factors (information infrastructure, executive information system and a new manufacturing paradigm) that are used to support the development of a new business model for competitiveness. They facilitate changes in organization structure in support of business transformation. A SME can source a good manufacturing practice using a model of academic-university collaboration to gain competitive advantage in the e-business world. The collaboration facilitates the change agents to use information systems development as a vehicle to increase the capability of executives in using information and knowledge management to gain higher responsiveness and customer satisfaction. The case company is used to illustrate the application of a web-based executive information system to interface internal communications with external operation. It explains where a good manufacturing practice may be re-applied by other SMEs to acquire skills as a learning organization grows in an extended enterprise setting.

  16. Perceptions of good medical practice in the NHS: a survey of senior health professionals.

    PubMed

    Hutchinson, A; Williams, M; Meadows, K; Barbour, R S; Jones, R

    1999-12-01

    To categorize senior health professionals' experience with poor medical practice in hospitals and in general practice, to describe perceptions which senior NHS staff have of good medical practice, and to describe how problems of poor medical practice are currently managed. A postal questionnaire survey. The questionnaire sought perceptions of good medical practice, asked participants to characterise deviations from good practice, and to describe experience with managing poor performance at the time of the introduction of the General Medical Council (GMC) performance procedures. A range of NHS settings in the UK: hospital trusts, health authorities/boards, local medical committees, community health councils. Senior health professionals involved in the management of medical professional performance. Perceptions of what constitutes good medical practice. Most respondents considered that persistent problems related to clinical practice (diagnosis, management, and outcome and prescribing) would require local management and, possibly, referral to the GMC performance procedures. Informal mechanisms, including informal discussion, education, training, and work shifting, were the most usual means of handling a doctor whose performance was poor. Many took a less serious view of deficiencies in performance on manner and attitude and communication, although consultation skills rather than technical skills comprised the greatest number of complaints about doctors. Senior NHS professionals seem reluctant to consider persistently poor consultation skills in the same critical light as they do persistently poor technical practice. These attitudes may need to change with the implementation of clinical governance and updated guidance from the GMC on what constitutes good medical practice.

  17. A practical discussion of risk management for manufacturing of pharmaceutical products.

    PubMed

    Mollah, A Hamid; Baseman, Harold S; Long, Mike; Rathore, Anurag S

    2014-01-01

    Quality risk management (QRM) is now a regulatory expectation, and it makes good business sense. The goal of the risk assessment is to increase process understanding and deliver safe and effective product to the patients. Risk analysis and management is an acceptable and effective way to minimize patient risk and determine the appropriate level of controls in manufacturing. While understanding the elements of QRM is important, knowing how to apply them in the manufacturing environment is essential for effective process performance and control. This article will preview application of QRM in pharmaceutical and biopharmaceutical manufacturing to illustrate how QRM can help the reader achieve that objective. There are several areas of risk that a drug company may encounter in pharmaceutical manufacturing, specifically addressing oral solid and liquid formulations. QRM tools can be used effectively to identify the risks and develop strategy to minimize or control them. Risks are associated throughout the biopharmaceutical manufacturing process-from raw material supply through manufacturing and filling operations to final distribution via a controlled cold chain process. Assessing relevant attributes and risks for biotechnology-derived products is more complicated and challenging for complex pharmaceuticals. This paper discusses key risk factors in biopharmaceutical manufacturing. Successful development and commercialization of pharmaceutical products is all about managing risks. If a company was to take zero risk, most likely the path to commercialization would not be commercially viable. On the other hand, if the risk taken was too much, the product is likely to have a suboptimal safety and efficacy profile and thus is unlikely to be a successful product. This article addresses the topic of quality risk management with the key objective of minimizing patient risk while creating an optimal process and product. Various tools are presented to aid implementation of these

  18. Tools to share good chairside teaching practice: a clinical scenario and appreciative questionnaire.

    PubMed

    Sweet, J; Wilson, J; Pugsley, L; Schofield, M

    2008-12-13

    This article provides a scenario for analysis of good chairside teaching practice to serve as a starting point for continued discussion in this complex field. Documented issues of good chairside teaching practice are cross-referenced to a clinical scenario with explanations in the form of a commentary. This provided the context for generating a set of questions that are provided as tools to support good chairside practice. These tools are designed to be used with 'Appreciative Inquiry', which claims that there is much to be gained by discovering where excellence is possible and elaborating upon this. Although this process can be carried out in single units or departments, it is proposed that collaboration between institutions would allow sharing of valuable innovations and greater understanding of educational training, production of good practice guidance and professional development of staff. This article is the third in a series of three and provides a scaffold for a scenario and questions to encourage collaboration in evolving and sharing good chairside teaching practice. The first article investigated the perceptions of stakeholders in chairside teaching at a single dental school and the second evaluated chairside teaching on a UK wide scale. A further accompanying article reviews some of the educational methodology and innovations in teaching and learning that may be applied to dentistry.

  19. Distance Learning. Leonardo da Vinci Series: Good Practices.

    ERIC Educational Resources Information Center

    Commission of the European Communities, Brussels (Belgium). Directorate-General for Education and Culture.

    This brochure, part of a series about good practices in vocational training in the European Union, describes 12 projects that use distance learning to promote lifelong learning in adults. The projects and their countries of origin are as follows: (1) 3D Project, training in the use of IT tools for 3D simulation and animation and practical…

  20. Good practices in transportation evacuation preparedness and response : results of the FHWA workshop series.

    DOT National Transportation Integrated Search

    2009-08-01

    This document provides an overview of the good practices identified during a series of multi-state workshops on Transportation Evacuation Preparedness and Response in four regions across the United States. Good practices are not presented in priority...

  1. Good practices in transportation evacuation preparedness and response : results of the FHWA Workshop Series

    DOT National Transportation Integrated Search

    2009-08-01

    This document provides an overview of the good practices identified during a series of multi-state workshops on Transportation Evacuation Preparedness and Response in four regions across the United States. Good practices are not presented in priority...

  2. A pilot-scale nonwoven roll goods manufacturing process reduces microbial burden to pharmacopeia acceptance levels for nonsterile hygiene applications

    USDA-ARS?s Scientific Manuscript database

    A total of seven source fiber types were selected for use in the manufacturing of nonwoven roll goods: polyester; polypropylene; rayon; greige cotton from two sources; mechanically cleaned greige cotton; and scoured and bleached cotton. The microbial burden of each source fiber was measured as a pr...

  3. Sharing Good Practices: Teenage Girls, Sport, and Physical Activities.

    ERIC Educational Resources Information Center

    Vescio, Johanna A.; Crosswhite, Janice J.

    2002-01-01

    Investigated initiatives to increase teenage girls' participation in sport and physical activities, examining good practice case studies from Australia. Surveys of national, state, and regional sporting organizations and various community and school organizations (including culturally diverse girls and girls with disabilities) highlighted three…

  4. Images of otoscopy: rate and extent of non-compliance with good practice standards.

    PubMed

    Crundwell, G; Harmer, J; Maltby, M; Mills, T; Neumann, C; Walsh, L; Baguley, D

    2015-01-01

    The British Society of Audiology has produced clear guidelines as to how otoscopy should be undertaken; however, no nationally recognised guidelines exist for the wider clinical community. Images of otoscopy appear in many books, journals, magazines and websites. This study aimed to determine the rate of non-compliance with good practice in images of otoscopy, the seriousness of the breach, and whether this is more common in sites for professionals or the general public. Google Images was searched using the terms 'otoscopy' and 'ear examination'. A total of 200 images were identified and collated. The images were reviewed for compliance with good practice standards. Only 12.75 per cent of the images were graded as having no breach of good practice standards. Professional websites have a responsibility to show best practice. When choosing an image, the source of the image needs to be carefully considered.

  5. 48 CFR 52.225-24 - Notice of Required Use of American Iron, Steel, and Manufactured Goods-Buy American Act...

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 48 Federal Acquisition Regulations System 2 2010-10-01 2010-10-01 false Notice of Required Use of American Iron, Steel, and Manufactured Goods-Buy American Act-Construction Materials Under Trade Agreements. 52.225-24 Section 52.225-24 Federal Acquisition Regulations System FEDERAL ACQUISITION REGULATION (CONTINUED) CLAUSES AND FORMS SOLICITATION...

  6. 48 CFR 52.225-24 - Notice of Required Use of American Iron, Steel, and Manufactured Goods-Buy American Act...

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 48 Federal Acquisition Regulations System 2 2011-10-01 2011-10-01 false Notice of Required Use of American Iron, Steel, and Manufactured Goods-Buy American Act-Construction Materials Under Trade Agreements. 52.225-24 Section 52.225-24 Federal Acquisition Regulations System FEDERAL ACQUISITION REGULATION (CONTINUED) CLAUSES AND FORMS SOLICITATION...

  7. 48 CFR 52.225-24 - Notice of Required Use of American Iron, Steel, and Manufactured Goods-Buy American Act...

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 48 Federal Acquisition Regulations System 2 2012-10-01 2012-10-01 false Notice of Required Use of American Iron, Steel, and Manufactured Goods-Buy American Act-Construction Materials Under Trade Agreements. 52.225-24 Section 52.225-24 Federal Acquisition Regulations System FEDERAL ACQUISITION REGULATION (CONTINUED) CLAUSES AND FORMS SOLICITATION...

  8. 2 CFR 176.150 - Notice of Required Use of American Iron, Steel, and Manufactured Goods-Section 1605 of the...

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ..., Steel, and Manufactured Goods-Section 1605 of the American Recovery and Reinvestment Act of 2009. 176... and Reinvestment Act of 2009 § 176.150 Notice of Required Use of American Iron, Steel, and..., maintenance, or repair of a public building or public work, and do not involve iron, steel, and/or...

  9. 2 CFR 176.150 - Notice of Required Use of American Iron, Steel, and Manufactured Goods-Section 1605 of the...

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ..., Steel, and Manufactured Goods-Section 1605 of the American Recovery and Reinvestment Act of 2009. 176... and Reinvestment Act of 2009 § 176.150 Notice of Required Use of American Iron, Steel, and..., maintenance, or repair of a public building or public work, and do not involve iron, steel, and/or...

  10. Prakriti-based research: Good reporting practices.

    PubMed

    Bhalerao, Supriya; Patwardhan, Kishor

    2016-03-01

    The recent advances in the fields of genomics, personalized medicine, and Ayurveda have motivated many researchers to look at the relationship between Prakriti (phenotype-based Ayurveda constitution) and various objective biological parameters. As a result, a number of studies reporting such a relationship have made their way into mainstream scholarly journals. However, when it comes to the protocols that these workers follow to identify one's Prakriti, there are several issues that are yet to be resolved. In this communication, we propose a few reporting practices that such workers are required to be encouraged to follow, while submitting their work on Prakriti to scholarly journals. We have arranged this proposal under the following domains that may serve as a preliminary checklist in this context: The textual references, validation process, assessment of characters, scoring pattern, weightage assignment, criterion for expressing the final Prakriti type, and a need to publish the complete Prakriti-determination tool. We advocate that only if the workers in the field adhere to these good reporting practices, one will be able to draw meaningful, generalizable, and applicable interpretations out of such studies. We also suggest that the editors of relevant scholarly journals may recommend these reporting practices while considering such reports for publication. Copyright © 2016 Transdisciplinary University, Bangalore and World Ayurveda Foundation. Published by Elsevier B.V. All rights reserved.

  11. Design and manufacture of monoclonal antibodies for radioimmunotherapy.

    PubMed

    Hale, G; Berrie, E; Bird, P

    2004-12-01

    antibodies is fundamental to their use for radioimmunotherapy. Besides the right selection of antibody specificity and affinity, recombinant antibodies can be designed to simplify manufacture and minimise unwanted side effects. Although many innovative new technologies have been developed in recent years, antibodies are still most commonly produced from mammalian cells and purified by column chromatography. Purification methods have to be designed and validated to remove potential contaminants, especially retroviruses, which in principle might be present in mammalian cell lines. Adherence to relevant ''Good Manufacturing Practices'' is mandatory in the production of any medicinal product and there are numerous guidelines regarding the manufacture of antibodies. This article outlines some methods used for fermentation, purification and quality control of antibodies intended for radiolabelling.

  12. Manufacturing of tattoo ink products today and in future: Europe.

    PubMed

    Michel, Ralf

    2015-01-01

    The article describes the European market situation and the legal framework in Europe. It shows the state-of-the-art production under ISO 9001:2008 quality management and describes the future of tattoo ink production based on good manufacturing practice guidelines for tattoo inks. © 2015 S. Karger AG, Basel.

  13. [Identifying indicators of good practice in clinical and healthcare management].

    PubMed

    Bermúdez Tamayo, C; Olry de Labry Lima, A; García Mochón, L

    To identify good practices in order to develop and implement indicators of health outcomes for clinical and healthcare management, as well as the characteristics for an indicator to be considered adequate. A scoping review was performed, with the following phases: 1) Search and identification of bibliography. 2) Selection of relevant documents. Including those studies that discussed issues related to good practices for the use of health indicators in the management field. Those published in a language other than English or Spanish or before 2006 were excluded. 3) Analysis and extraction of information. 4) Consultation with stakeholders, using a qualitative methodology through Concept Mapping, with the participation of 40 experts (decision-makers, scientific societies, and health professionals). The data collection process included an inductive and structured procedure, with prioritisation of ideas grouped into clusters, according to feasibility and importance criteria (0-10 scale). Good practices identified 2 levels: 1) macro-management: Define a framework for the evaluation of indicators and establish a benchmark of indicators. 2) meso-management: Establish indicators according to evidence and expert consensus, taking into account priority areas and topics, testing before final use, and communicate results adequately. The characteristics of a suitable indicator are: 1) Approach of an important issue, 2) Scientific validity, 3) Possibility of measurement with reliable data, 4) Meaning of useful and applicable measurement, and 5) Wide scope. The best practices for the use of indicators in clinical and healthcare management can make it easier to monitor performance and accountability, as well as to support the decision-making addressed at the development of initiatives for quality improvement. Copyright © 2018 SECA. Publicado por Elsevier España, S.L.U. All rights reserved.

  14. Standards of Good Practice for Education Abroad. Fourth Edition

    ERIC Educational Resources Information Center

    Forum on Education Abroad, 2011

    2011-01-01

    This fourth edition of the Forum on Education Abroad's "Standards of Good Practice for Education Abroad" augments previous editions of the "Standards." Since the last edition was published in 2008, Forum member institutions and organizations have implemented the Standards in program development and assessment, using the Standards in the Forum's…

  15. 21 CFR 1271.150 - Current good tissue practice requirements.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ....150 Section 1271.150 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS Current Good Tissue Practice § 1271.150... implemented for reproductive HCT/Ps described in § 1271.10 and regulated solely under section 361 of the...

  16. 21 CFR 1271.150 - Current good tissue practice requirements.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ....150 Section 1271.150 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS Current Good Tissue Practice § 1271.150... implemented for reproductive HCT/Ps described in § 1271.10 and regulated solely under section 361 of the...

  17. 21 CFR 1271.150 - Current good tissue practice requirements.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ....150 Section 1271.150 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS Current Good Tissue Practice § 1271.150... implemented for reproductive HCT/Ps described in § 1271.10 and regulated solely under section 361 of the...

  18. 21 CFR 1271.150 - Current good tissue practice requirements.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ....150 Section 1271.150 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS Current Good Tissue Practice § 1271.150... implemented for reproductive HCT/Ps described in § 1271.10 and regulated solely under section 361 of the...

  19. VET Providers Planning to Deliver Degrees: Good Practice Guide

    ERIC Educational Resources Information Center

    National Centre for Vocational Education Research (NCVER), 2015

    2015-01-01

    This good practice guide is intended to assist public and private registered training organisations (RTOs) planning to commence higher education (HE) delivery. The guide is based on research undertaken by Victor Callan and Kaye Bowman, who completed case studies with six providers currently delivering higher education qualifications in addition to…

  20. The impact of preventive maintenance practices on manufacturing performance: A proposed model for SMEs in Malaysia

    NASA Astrophysics Data System (ADS)

    Lazim, Halim Mad; Taib, Che Azlan; Lamsali, Hendrik; Saleh, Mohamed Najib; Subramaniam, Chandrakantan

    2016-08-01

    Preventive maintenance (PM) plays important role to avoid or mitigate potential stoppages and disruptions of equipment or machinery from occurring in daily operations. PM emphasized total employee involvement and it is important for companies as well as Small and Medium Sized Enterprises (SMEs). SME sectors contribution to the Malaysian economy makes up 95% of the total manufacturers, however PM remain relatively lacking. The ability, reliability and effective maintenance management is highly important in order to achieve desired manufacturing performance. Therefore, organizational capability in planning, controlling, implementing and monitoring PM activities is important. Furthermore, empirical evidence on the potential impact of PM practices towards manufacturing performance with organizational capability as a moderating effect is still limited and indecisive. Henceforth, this paper aims to explore and investigate potential relationships between PM practices and manufacturing performance moderated by organizational capability in the contact of Malaysian SMEs in the manufacturing sector. Correspondently, the study intends to propose a new research framework and hypotheses to examine the abovementioned relationships. The proposed framework includes PM team, PM strategy and planned maintenance as the determinants, while organizational capability serves as the moderating variable. Manufacturing performance will be viewed in terms of innovation and financial factors. Proposed research direction and conclusion are discussed at the end of the study.

  1. Implementing Good Practices Programs to Encourage Production of High-Quality, Safer Produce in Mississippi

    ERIC Educational Resources Information Center

    Mahmoud, Barakat S. M.; Stafne, Eric T.; Coker, Christine H.; Bachman, Gary R.; Bell, Nicole

    2016-01-01

    Fifty-four growers/producers attended four 1-day good agricultural practices (GAP) and good handling practices (GHP) workshops at four locations in Mississippi. Pre- and post workshop survey data indicated that the participants' food safety knowledge increased by 15%. Furthermore, the workshops helped producers develop their own food safety plans.…

  2. Defending the four principles approach as a good basis for good medical practice and therefore for good medical ethics.

    PubMed

    Gillon, Raanan

    2015-01-01

    This paper argues that the four prima facie principles-beneficence, non-maleficence, respect for autonomy and justice-afford a good and widely acceptable basis for 'doing good medical ethics'. It confronts objections that the approach is simplistic, incompatible with a virtue-based approach to medicine, that it requires respect for autonomy always to have priority when the principles clash at the expense of clinical obligations to benefit patients and global justice. It agrees that the approach does not provide universalisable methods either for resolving such moral dilemmas arising from conflict between the principles or their derivatives, or universalisable methods for resolving disagreements about the scope of these principles-long acknowledged lacunae but arguably to be found, in practice, with all other approaches to medical ethics. The value of the approach, when properly understood, is to provide a universalisable though prima facie set of moral commitments which all doctors can accept, a basic moral language and a basic moral analytic framework. These can underpin an intercultural 'moral mission statement' for the goals and practice of medicine. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  3. Guide of good practices for occupational radiological protection in plutonium facilities

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    NONE

    1998-06-01

    This Technical Standard (TS) does not contain any new requirements. Its purpose is to provide guides to good practice, update existing reference material, and discuss practical lessons learned relevant to the safe handling of plutonium. the technical rationale is given to allow US Department of Energy (DOE) health physicists to adapt the recommendations to similar situations throughout the DOE complex. Generally, DOE contractor health physicists will be responsible to implement radiation protection activities at DOE facilities and DOE health physicists will be responsible for oversight of those activities. This guidance is meant to be useful for both efforts. This TSmore » replaces PNL-6534, Health Physics Manual of Good Practices for Plutonium Facilities, by providing more complete and current information and by emphasizing the situations that are typical of DOE`s current plutonium operations; safe storage, decontamination, and decommissioning (environmental restoration); and weapons disassembly.« less

  4. Good Publication Practice for Communicating Company-Sponsored Medical Research: GPP3.

    PubMed

    Battisti, Wendy P; Wager, Elizabeth; Baltzer, Lise; Bridges, Dan; Cairns, Angela; Carswell, Christopher I; Citrome, Leslie; Gurr, James A; Mooney, LaVerne A; Moore, B Jane; Peña, Teresa; Sanes-Miller, Carol H; Veitch, Keith; Woolley, Karen L; Yarker, Yvonne E

    2015-09-15

    This updated Good Publication Practice (GPP) guideline, known as GPP3, builds on earlier versions and provides recommendations for individuals and organizations that contribute to the publication of research results sponsored or supported by pharmaceutical, medical device, diagnostics, and biotechnology companies. The recommendations are designed to help individuals and organizations maintain ethical and transparent publication practices and comply with legal and regulatory requirements. These recommendations cover publications in peer-reviewed journals and presentations (oral or poster) at scientific congresses. The International Society for Medical Publication Professionals invited more than 3000 professionals worldwide to apply for a position on the steering committee, or as a reviewer, for this guideline. The GPP2 authors reviewed all applications (n = 241) and assembled an 18-member steering committee that represented 7 countries and a diversity of publication professions and institutions. From the 174 selected reviewers, 94 sent comments on the second draft, which steering committee members incorporated after discussion and consensus. The resulting guideline includes new sections (Principles of Good Publication Practice for Company-Sponsored Medical Research, Data Sharing, Studies That Should Be Published, and Plagiarism), expands guidance on the International Committee of Medical Journal Editors' authorship criteria and common authorship issues, improves clarity on appropriate author payment and reimbursement, and expands information on the role of medical writers. By following good publication practices (including GPP3), individuals and organizations will show integrity; accountability; and responsibility for accurate, complete, and transparent reporting in their publications and presentations.

  5. Helping Displaced Older Workers Get Back into Employment: Good Practice Guide

    ERIC Educational Resources Information Center

    Callahan, Victor J.; Bowman, Kaye

    2015-01-01

    This good practice guide is based on the report "Industry Restructuring and Job Loss: Helping Older Workers Get Back into Employment" by Victor J. Callan and Kaye Bowman. The aim of the research was to identify evidence-based practices that led to successful skills transfer, re-skilling, training and the attainment of new jobs for older…

  6. Influence of Different Container Closure Systems and Capping Process Parameters on Product Quality and Container Closure Integrity (CCI) in GMP Drug Product Manufacturing.

    PubMed

    Mathaes, Roman; Mahler, Hanns-Christian; Roggo, Yves; Huwyler, Joerg; Eder, Juergen; Fritsch, Kamila; Posset, Tobias; Mohl, Silke; Streubel, Alexander

    2016-01-01

    Capping equipment used in good manufacturing practice manufacturing features different designs and a variety of adjustable process parameters. The overall capping result is a complex interplay of the different capping process parameters and is insufficiently described in literature. It remains poorly studied how the different capping equipment designs and capping equipment process parameters (e.g., pre-compression force, capping plate height, turntable rotating speed) contribute to the final residual seal force of a sealed container closure system and its relation to container closure integrity and other drug product quality parameters. Stopper compression measured by computer tomography correlated to residual seal force measurements.In our studies, we used different container closure system configurations from different good manufacturing practice drug product fill & finish facilities to investigate the influence of differences in primary packaging, that is, vial size and rubber stopper design on the capping process and the capped drug product. In addition, we compared two large-scale good manufacturing practice manufacturing capping equipment and different capping equipment settings and their impact on product quality and integrity, as determined by residual seal force.The capping plate to plunger distance had a major influence on the obtained residual seal force values of a sealed vial, whereas the capping pre-compression force and the turntable rotation speed showed only a minor influence on the residual seal force of a sealed vial. Capping process parameters could not easily be transferred from capping equipment of different manufacturers. However, the residual seal force tester did provide a valuable tool to compare capping performance of different capping equipment. No vial showed any leakage greater than 10(-8)mbar L/s as measured by a helium mass spectrometry system, suggesting that container closure integrity was warranted in the residual seal force range

  7. Assessing the Importance of Domestic Vaccine Manufacturing Centers: An Overview of Immunization Programs, Vaccine Manufacture, and Distribution.

    PubMed

    Rey-Jurado, Emma; Tapia, Felipe; Muñoz-Durango, Natalia; Lay, Margarita K; Carreño, Leandro J; Riedel, Claudia A; Bueno, Susan M; Genzel, Yvonne; Kalergis, Alexis M

    2018-01-01

    Vaccines have significantly reduced the detrimental effects of numerous human infectious diseases worldwide, helped to reduce drastically child mortality rates and even achieved eradication of major pathogens, such as smallpox. These achievements have been possible due to a dedicated effort for vaccine research and development, as well as an effective transfer of these vaccines to public health care systems globally. Either public or private institutions have committed to developing and manufacturing vaccines for local or international population supply. However, current vaccine manufacturers worldwide might not be able to guarantee sufficient vaccine supplies for all nations when epidemics or pandemics events could take place. Currently, different countries produce their own vaccine supplies under Good Manufacturing Practices, which include the USA, Canada, China, India, some nations in Europe and South America, such as Germany, the Netherlands, Italy, France, Argentina, and Brazil, respectively. Here, we discuss some of the vaccine programs and manufacturing capacities, comparing the current models of vaccine management between industrialized and developing countries. Because local vaccine production undoubtedly provides significant benefits for the respective population, the manufacture capacity of these prophylactic products should be included in every country as a matter of national safety.

  8. Assessing the Importance of Domestic Vaccine Manufacturing Centers: An Overview of Immunization Programs, Vaccine Manufacture, and Distribution

    PubMed Central

    Rey-Jurado, Emma; Tapia, Felipe; Muñoz-Durango, Natalia; Lay, Margarita K.; Carreño, Leandro J.; Riedel, Claudia A.; Bueno, Susan M.; Genzel, Yvonne; Kalergis, Alexis M.

    2018-01-01

    Vaccines have significantly reduced the detrimental effects of numerous human infectious diseases worldwide, helped to reduce drastically child mortality rates and even achieved eradication of major pathogens, such as smallpox. These achievements have been possible due to a dedicated effort for vaccine research and development, as well as an effective transfer of these vaccines to public health care systems globally. Either public or private institutions have committed to developing and manufacturing vaccines for local or international population supply. However, current vaccine manufacturers worldwide might not be able to guarantee sufficient vaccine supplies for all nations when epidemics or pandemics events could take place. Currently, different countries produce their own vaccine supplies under Good Manufacturing Practices, which include the USA, Canada, China, India, some nations in Europe and South America, such as Germany, the Netherlands, Italy, France, Argentina, and Brazil, respectively. Here, we discuss some of the vaccine programs and manufacturing capacities, comparing the current models of vaccine management between industrialized and developing countries. Because local vaccine production undoubtedly provides significant benefits for the respective population, the manufacture capacity of these prophylactic products should be included in every country as a matter of national safety. PMID:29403503

  9. Good manufacturing practice-compliant cell sorting and large-scale expansion of single KIR-positive alloreactive human natural killer cells for multiple infusions to leukemia patients.

    PubMed

    Siegler, Uwe; Meyer-Monard, Sandrine; Jörger, Simon; Stern, Martin; Tichelli, André; Gratwohl, Alois; Wodnar-Filipowicz, Aleksandra; Kalberer, Christian P

    2010-10-01

    Alloreactive natural killer (NK) cells are potent effectors of innate anti-tumor defense. The introduction of NK cell-based immunotherapy to current treatment options in acute myeloid leukemia (AML) requires NK cell products with high anti-leukemic efficacy optimized for clinical use. We describe a good manufacturing practice (GMP)-compliant protocol of large-scale ex vivo expansion of alloreactive NK cells suitable for multiple donor lymphocyte infusions (NK-DLI) in AML. CliniMACS-purified NK cells were cultured in closed air-permeable culture bags with certified culture medium and components approved for human use [human serum, interleukin (IL)-2, IL-15 and anti-CD3 antibody] and with autologous irradiated feeder cells. NK cells (6.0 ± 1.2 x 10(8)) were purified from leukaphereses (8.1 ± 0.8 L) of six healthy donors and cultured under GMP conditions. NK cell numbers increased 117.0 ± 20.0-fold in 19 days. To reduce the culture volume associated with expansion of bulk NK cells and to expand selectively the alloreactive NK cell subsets, GMP-certified cell sorting was introduced to obtain cells with single killer immunoglobulin-like receptor (KIR) specificities. The subsequent GMP-compliant expansion of single KIR+ cells was 268.3 ± 66.8-fold, with a contaminating T-cell content of only 0.006 ± 0.002%. The single KIR-expressing NK cells were cytotoxic against HLA-mismatched primary AML blasts in vitro and effectively reduced tumor cell load in vivo in NOD/SCID mice transplanted with human AML. The approach to generating large numbers of GMP-grade alloreactive NK cells described here provides the basis for clinical efficacy trials of NK-DLI to complement and advance therapeutic strategies against human AML.

  10. What makes a good GP? An empirical perspective on virtue in general practice

    PubMed Central

    Braunack-Mayer, A

    2005-01-01

    This paper takes a virtuist approach to medical ethics to explore, from an empirical angle, ideas about settled ways of living a good life. Qualitative research methods were used to analyse the ways in which a group of 15 general practitioners (GPs) articulated notions of good doctoring and the virtues in their work. I argue that the GPs, whose talk is analysed here, defined good general practice in terms of the ideals of accessibility, comprehensiveness, and continuity. They regarded these ideals significant both for the way they dealt with morally problematic situations and for how they conducted their professional lives more generally. In addition, I argue that the GPs who articulated these ideals most clearly were able to, in part, because they shared the experience of working in rural areas. This experience helped them to develop an understanding of the nature of general practice that their urban colleagues were less able to draw on. In that sense, the structural and organisational framework of general practice in rural areas provided the context for their understanding of ideals in general practice. PMID:15681671

  11. Evaluation of Practicing sustainable Industrial Solid Waste Minimization by Manufacturing Firms in Malaysia: Strengths and Weaknesses.

    PubMed

    Mallak, Shadi Kafi; Bakri Ishak, Mohd; Mohamed, Ahmad Fariz

    2016-09-13

    Malaysia is facing an increasing trend in industrial solid waste generation due to industrial development.Thus there is a paramount need in taking a serious action to move toward sustainable industrial waste management. The main aim of this study is to assess practicing solid waste minimization by manufacturing firms in Shah Alam industrial state, Malaysia. This paper presents a series of descriptive and inferential statistical analysis regarding the level and effects of practicing waste minimization methods, and seriousness of barriers preventing industries from practicing waste minimization methods. For this purpose the survey questions were designed such that both quantitative (questionnaire) and qualitative (semi-structures interview) data were collected concurrently. Analysis showed that, the majority of firms (92%) dispose their wastes rather than practice other sustainable waste management options. Also waste minimization methods such as segregation of wastes, on-site recycle and reuse, improve housekeeping and equipment modification were found to have significant contribution in waste reduction (p<0.05). Lack of expertise (M=3.50), lack of enough information (M= 3.54), lack of equipment modification (M= 3.16) and lack of specific waste minimization guidelines (M=3.49) have higher mean scores comparing with other barriers in different categories. These data were interpreted for elaborating of SWOT and TOWS matrix to highlight strengths, weaknesses, threats and opportunities. Accordingly, ten policies were recommended for improvement of practicing waste minimization by manufacturing firms as the main aim of this research. Implications This manuscript critically analysis waste minimization practices by manufacturing firms in Malaysia. Both qualitative and quantitative data collection and analysis were conducted to formulate SWOT and TOWS matrix in order to recommend policies and strategies for improvement of solid waste minimization by manufacturing industries

  12. Good vaccination practice: it all starts with a good vaccine storage temperature.

    PubMed

    Vangroenweghe, Frédéric

    2017-01-01

    Recent introduction of strategies to reduce antibiotic use in food animal production implies an increased use of vaccines in order to prevent the economic impact of several important diseases in swine. Good Vaccination Practice (GVP) is an overall approach on the swine farm aiming to obtain maximal efficacy of vaccination through good storage, preparation and finally correct application to the target animals. In order to have a better insight into GVP on swine farms and the vaccine storage conditions, a survey on vaccination practices was performed on a farmers' fair and temperatures in the vaccine storage refrigerators were measured during farm visits over a period of 1 year. The survey revealed that knowledge on GVP, such as vaccine storage and handling, needle management and injection location could be improved. Less than 10% had a thermometer in their vaccine storage refrigerator on the moment of the visit. Temperature measurement revealed that only 71% of the measured refrigerators were in line with the recommended temperature range of +2 °C to +8 °C. Both below +2 °C and above +8 °C temperatures were registered during all seasons of the year. Compliance was lower during summer with an average temperature of 9.2 °C while only 43% of the measured temperatures were within the recommended range. The present study clearly showed the need for continuous education on GVP for swine veterinarians, swine farmers and their farm personnel in general and vaccine storage management in particular. In veterinary medicine, the correct storage of vaccines is crucial since both too low and too high temperatures can provoke damage to specific vaccine types. Adjuvanted killed or subunit vaccines can be damaged (e.g. structure of aluminiumhydroxide in adjuvans) by too low temperatures (below 0 °C), whereas lyophilized live vaccines are susceptible (e.g. loss of vaccine potency) to heat damage by temperatures above +8 °C. In conclusion, knowledge and awareness of GVP

  13. Characterization of the animal by-product meal industry in Costa Rica: Manufacturing practices through the production chain and food safety.

    PubMed

    Leiva, A; Granados-Chinchilla, F; Redondo-Solano, M; Arrieta-González, M; Pineda-Salazar, E; Molina, A

    2018-06-01

    Animal by-product rendering establishments are still relevant industries worldwide. Animal by-product meal safety is paramount to protect feed, animals, and the rest of the food chain from unwanted contamination. As microbiological contamination may arise from inadequate processing of slaughterhouse waste and deficiencies in good manufacturing practices within the rendering facilities, we conducted an overall establishment's inspection, including the product in several parts of the process.An evaluation of the Good Manufacturing Practices (GMP) was carried out, which included the location and access (i.e., admission) to the facilities, integrated pest management programs, physical condition of the facilities (e.g., infrastructure), equipments, vehicles and transportation, as well as critical control points (i.e., particle size and temperature set at 50 mm, 133°C at atmospheric pressure for 20 min, respectively) recommended by the OIE and the European Commission. The most sensitive points according to the evaluation are physical structure of the facilities (avg 42.2%), access to the facilities (avg 48.6%), and cleaning procedures (avg 51.4%).Also, indicator microorganisms (Salmonella spp., Clostridium spp., total coliforms, E. coli, E. coli O157:H7) were used to evaluate the safety in different parts of the animal meal production process. There was a prevalence of Salmonella spp. of 12.9, 14.3, and 33.3% in Meat and Bone Meal (MBM), poultry by-products, and fish meal, respectively. However, there were no significant differences (P = 0.73) in the prevalence between the different animal meals, according to the data collected.It was also observed that renderings associated with the poultry industry (i.e., 92.0%) obtained the best ratings overall, which reflects a satisfactory development of this sector and the integration of its production system as a whole.

  14. Characterization of the animal by-product meal industry in Costa Rica: Manufacturing practices through the production chain and food safety

    PubMed Central

    Leiva, A; Granados-Chinchilla, F; Redondo-Solano, M; Arrieta-González, M; Pineda-Salazar, E; Molina, A

    2018-01-01

    ABSTRACT Animal by-product rendering establishments are still relevant industries worldwide. Animal by-product meal safety is paramount to protect feed, animals, and the rest of the food chain from unwanted contamination. As microbiological contamination may arise from inadequate processing of slaughterhouse waste and deficiencies in good manufacturing practices within the rendering facilities, we conducted an overall establishment's inspection, including the product in several parts of the process. An evaluation of the Good Manufacturing Practices (GMP) was carried out, which included the location and access (i.e., admission) to the facilities, integrated pest management programs, physical condition of the facilities (e.g., infrastructure), equipments, vehicles and transportation, as well as critical control points (i.e., particle size and temperature set at 50 mm, 133°C at atmospheric pressure for 20 min, respectively) recommended by the OIE and the European Commission. The most sensitive points according to the evaluation are physical structure of the facilities (avg 42.2%), access to the facilities (avg 48.6%), and cleaning procedures (avg 51.4%). Also, indicator microorganisms (Salmonella spp., Clostridium spp., total coliforms, E. coli, E. coli O157:H7) were used to evaluate the safety in different parts of the animal meal production process. There was a prevalence of Salmonella spp. of 12.9, 14.3, and 33.3% in Meat and Bone Meal (MBM), poultry by-products, and fish meal, respectively. However, there were no significant differences (P = 0.73) in the prevalence between the different animal meals, according to the data collected. It was also observed that renderings associated with the poultry industry (i.e., 92.0%) obtained the best ratings overall, which reflects a satisfactory development of this sector and the integration of its production system as a whole. PMID:29562297

  15. Developing a policy for paediatric biobanks: principles for good practice

    PubMed Central

    Hens, Kristien; Van El, Carla E; Borry, Pascal; Cambon-Thomsen, Anne; Cornel, Martina C; Forzano, Francesca; Lucassen, Anneke; Patch, Christine; Tranebjaerg, Lisbeth; Vermeulen, Eric; Salvaterra, Elena; Tibben, Aad; Dierickx, Kris

    2013-01-01

    The participation of minors in biobank research can offer great benefits for science and health care. However, as minors are a vulnerable population they are also in need of adequate protective measures when they are enrolled in research. Research using biobanked biological samples from children poses additional ethical issues to those raised by research using adult biobanks. For example, small children have only limited capacity, if any, to understand the meaning and implications of the research and to give a documented agreement to it. Older minors are gradually acquiring this capacity. We describe principles for good practice related to the inclusion of minors in biobank research, focusing on issues related to benefits and subsidiarity, consent, proportionality and return of results. Some of these issues are currently heavily debated, and we conclude by providing principles for good practice for policy makers of biobanks, researchers and anyone involved in dealing with stored tissue samples from children. Actual implementation of the principles will vary according to different jurisdictions. PMID:22713814

  16. Promoting good health research practice in low- and middle-income countries

    PubMed Central

    Mahendradhata, Yodi; Nabieva, Jamila; Ahmad, Riris Andono; Henley, Patricia; Launois, Pascal; Merle, Corinne; Maure, Christine; Horstick, Olaf; Elango, Varalakshmi

    2016-01-01

    Background Good clinical practice (GCP) guidelines have been the source of improvement in the quality of clinical trials; however, there are limitations to the application of GCP in the conduct of health research beyond industry-sponsored clinical trials. The UNICEF/UNDP/World Bank/WHO Special Program for Research and Training in Tropical Disease is promoting good practice in all health research involving human through the Good Health Research Practice (GHRP) training program initiative. Objective To report the results of piloting the GHRP training program and formulate further steps to harness GHRP for promoting good practices in all health research involving human, particularly in low- and middle-income countries (LMICs). Design The objective of this training is to impart knowledge and skills for the application of ethical and quality principles to the design, conduct, recording, and reporting of health research involving human participants based on the level of risk, to ensure a fit-for-purpose quality system. This has been formulated into five sequential modules to be delivered in a 4-day course. Four courses have been organized in the pilot phase (2014–2015). The courses have been evaluated and assessed based on course feedback (quantitative and qualitative data) collected during course implementation and qualitative email-based pre- and post-course evaluation. Results Participants were highly satisfied with the course content and its organization. The relevance and applicability of the course content resulted in positive feedback and an articulated willingness to adapt and disseminate the course. Action points to strengthen the training program have been identified, and showed the imminent need to develop a consensus with a broader range of key stakeholders on the final set of GHRP standards and means for implementation. Conclusions There is an urgent need to harness the momentum to promote high-quality and ethical health research in LMICs through scaling

  17. Practice-based Research Network Research Good Practices (PRGPs): Summary of Recommendations.

    PubMed

    Dolor, Rowena J; Campbell-Voytal, Kimberly; Daly, Jeanette; Nagykaldi, Zsolt J; O'Beirne, Maeve; Sterling, Pamela; Fagnan, Lyle J; Levy, Barcey; Michaels, LeAnn; Louks, Hannah A; Smith, Paul; Aspy, Cheryl B; Patterson, V Beth; Kano, Miria; Sussman, Andrew L; Williams, Robert; Neale, Anne Victoria

    2015-12-01

    Practice-based research networks (PBRNs) conduct research in community settings, which poses quality control challenges to the integrity of research, such as study implementation and data collection. A foundation for improving research processes within PBRNs is needed to ensure research integrity. Network directors and coordinators from seven U.S.-based PBRNs worked with a professional team facilitator during semiannual in-person meetings and monthly conference calls to produce content for a compendium of recommended research practices specific to the context of PBRNs. Participants were assigned to contribute content congruent with their expertise. Feedback on the draft document was obtained from attendees at the preconference workshop at the annual PBRN meeting in 2013. A revised document was circulated to additional PBRN peers prior to finalization. The PBRN Research Good Practices (PRGPs) document is organized into four chapters: (1) Building PBRN Infrastructure; (2) Study Development and Implementation; (3) Data Management, and (4) Dissemination Policies. Each chapter contains an introduction, detailed procedures for each section, and example resources with information links. The PRGPs is a PBRN-specific resource to facilitate PBRN management and staff training, to promote adherence to study protocols, and to increase validity and generalizability of study findings. © 2015 Wiley Periodicals, Inc.

  18. Simulation Design for Off-Line Training of Practical Lean Manufacturing Concepts for Visual Inspection

    ERIC Educational Resources Information Center

    Tetteh, Edem; McWilliams, Douglas

    2010-01-01

    Customer needs for high-quality goods and the risk of product-liability litigation against businesses have made companies look for a way to sustain quality assurance in their products and services. Lean manufacturing is the latest and most successful system being used by companies to turn their business around. Visual inspection plays an important…

  19. Understanding Graduate School Aspirations: The Effect of Good Teaching Practices

    ERIC Educational Resources Information Center

    Hanson, Jana Marie

    2013-01-01

    This study examined the effects of good teaching practices on post-baccalaureate degree aspirations using logistic regression techniques on a multi-institutional, longitudinal sample of students at four-year colleges and universities. Using College Choice and College Outcomes models as a theoretical foundation, I examined whether eight good…

  20. Multiple Criteria Decision Analysis for Health Care Decision Making--Emerging Good Practices: Report 2 of the ISPOR MCDA Emerging Good Practices Task Force.

    PubMed

    Marsh, Kevin; IJzerman, Maarten; Thokala, Praveen; Baltussen, Rob; Boysen, Meindert; Kaló, Zoltán; Lönngren, Thomas; Mussen, Filip; Peacock, Stuart; Watkins, John; Devlin, Nancy

    2016-01-01

    Health care decisions are complex and involve confronting trade-offs between multiple, often conflicting objectives. Using structured, explicit approaches to decisions involving multiple criteria can improve the quality of decision making. A set of techniques, known under the collective heading, multiple criteria decision analysis (MCDA), are useful for this purpose. In 2014, ISPOR established an Emerging Good Practices Task Force. The task force's first report defined MCDA, provided examples of its use in health care, described the key steps, and provided an overview of the principal methods of MCDA. This second task force report provides emerging good-practice guidance on the implementation of MCDA to support health care decisions. The report includes: a checklist to support the design, implementation and review of an MCDA; guidance to support the implementation of the checklist; the order in which the steps should be implemented; illustrates how to incorporate budget constraints into an MCDA; provides an overview of the skills and resources, including available software, required to implement MCDA; and future research directions. Copyright © 2016 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

  1. Knowledge for the good of the individual and society: linking philosophy, disciplinary goals, theory, and practice.

    PubMed

    McCurry, Mary K; Revell, Susan M Hunter; Roy, Sr Callista

    2010-01-01

    Nursing as a profession has a social mandate to contribute to the good of society through knowledge-based practice. Knowledge is built upon theories, and theories, together with their philosophical bases and disciplinary goals, are the guiding frameworks for practice. This article explores a philosophical perspective of nursing's social mandate, the disciplinary goals for the good of the individual and society, and one approach for translating knowledge into practice through the use of a middle-range theory. It is anticipated that the integration of the philosophical perspective and model into nursing practice will strengthen the philosophy, disciplinary goal, theory, and practice links and expand knowledge within the discipline. With the focus on humanization, we propose that nursing knowledge for social good will embrace a synthesis of the individual and the common good. This approach converges vital and agency needs described by Hamilton and the primacy of maintaining the heritage of the good within the human species as outlined by Maritain. Further, by embedding knowledge development in a changing social and health care context, nursing focuses on the goals of clinical reasoning and action. McCubbin and Patterson's Double ABCX Model of Family Adaptation was used as an example of a theory that can guide practice at the community and global level. Using the theory-practice link as a foundation, the Double ABCX model provides practising nurses with one approach to meet the needs of individuals and society. The integration of theory into nursing practice provides a guide to achieve nursing's disciplinary goals of promoting health and preventing illness across the globe. When nursing goals are directed at the synthesis of the good of the individual and society, nursing's social and moral mandate may be achieved.

  2. Good Laboratory Practice. Part 2. Recording and Retaining Raw Data

    ERIC Educational Resources Information Center

    Wedlich, Richard C.; Libera, Agata E.; Pires, Amanda; Tellarini, Cassandra

    2013-01-01

    A clear understanding of how "raw data" is defined, recorded, and retained in the laboratory record is essential to the chemist employed in the laboratory compliant with the Good Laboratory Practices regulations. This article is intended to provide an understanding by drawing upon examples taken from the modern pharmaceutical analysis…

  3. Investigating Good Practice in Supporting Deaf Pupils in Mainstream Schools.

    ERIC Educational Resources Information Center

    Powers, Steve

    2001-01-01

    A survey of parents, teachers, therapists, psychologists, and deaf adults (n=628) and 15 case study sites were used to identify the following good practices supporting deaf students in mainstream schools: direct support for teachers of the deaf, joint planning by support and mainstream teachers, student involvement in decision making, and…

  4. Adenovirus-mediated transfer of hepatocyte growth factor gene to human dental pulp stem cells under good manufacturing practice improves their potential for periodontal regeneration in swine.

    PubMed

    Cao, Yu; Liu, Zhenhai; Xie, Yilin; Hu, Jingchao; Wang, Hua; Fan, Zhipeng; Zhang, Chunmei; Wang, Jingsong; Wu, Chu-Tse; Wang, Songlin

    2015-12-15

    Periodontitis is one of the most widespread infectious diseases in humans. We previously promoted significant periodontal tissue regeneration in swine models with the transplantation of autologous periodontal ligament stem cells (PDLSCs) and PDLSC sheet. We also promoted periodontal tissue regeneration in a rat model with a local injection of allogeneic bone marrow mesenchymal stem cells. The purpose of the present study is to investigate the roles of the hepatocyte growth factor (HGF) and human dental pulp stem cells (DPSCs) in periodontal tissue regeneration in swine. In the present study, we transferred an adenovirus that carried HGF gene into human DPSCs (HGF-hDPSCs) under good manufacturing practice (GMP) conditions. These cells were then transplanted into a swine model for periodontal regeneration. Twenty miniature pigs were used to generate periodontitis with bone defect of 5 mm in width, 7 mm in length, and 3 mm in depth. After 12 weeks, clinical, radiological, quantitative and histological assessment of regenerated periodontal tissues was performed to compare periodontal regeneration in swine treated with cell implantation. Our study showed that injecting HGF-hDPSCs into this large animal model could significantly improve periodontal bone regeneration and soft tissue healing. A hDPSC or HGF-hDPSC sheet showed superior periodontal tissue regeneration compared to the injection of dissociated cells. However, the sheets required surgical placement; thus, they were suitable for surgically-managed periodontitis treatments. The adenovirus-mediated transfer of the HGF gene markedly decreased hDPSC apoptosis in a hypoxic environment or in serum-free medium, and it increased blood vessel regeneration. This study indicated that HGF-hDPSCs produced under GMP conditions significantly improved periodontal bone regeneration in swine; thus, this method represents a potential clinical application for periodontal regeneration.

  5. Variable implementation of good practice recommendations for the assessment and management of UK children with neurodisability.

    PubMed

    Gray, L; Gibbs, J; Jolleff, N; Williams, J; McConachie, H; Parr, J R

    2015-11-01

    The aims of this study were to determine whether UK child development teams (CDTs) have implemented good practice recommendations for the co-ordinated assessment and support of children with neurodisability and to explore some of the factors associated with variations in good practice implementation. Surveys were sent to every UK CDT in 2009/2010. Responses about CDT provision and ways of working were compared with good practice recommendations from national policy documents and professional organizations. The extent to which CDTs in England and Wales met 11 selected good practice recommendations was scored; teams in Scotland and Northern Ireland were given a score out of 9 to reflect the optional use of the common assessment framework and early support materials in these countries. Responses were received from 225/240 (94%) UK CDTs. Thirty-seven per cent of CDTs in England and Wales had implemented nine or more of the 11 recommendations. Fifty-nine per cent of teams in Scotland and 78% of teams in Northern Ireland met between six and nine recommendations of good working practice. Higher levels of implementation of recommendations were found when the CDT had a Child Development Centre base and for teams who had received increased funding in the 5 years preceding the survey. There was considerable variability in the degree to which CDTs implemented good practice recommendations for the diagnosis and management of children with neurodisability. Evidence about child and parent satisfaction, and the effectiveness of CDT practices and provision, is required, so policymakers, healthcare commissioners and clinicians can provide the most appropriate services to children with neurodisability and their families. © 2015 John Wiley & Sons Ltd.

  6. Seminar for High School Students “Practice on Manufacturing Technology by Advanced Machine Tools”

    NASA Astrophysics Data System (ADS)

    Marui, Etsuo; Yamawaki, Masao; Taga, Yuken; Omoto, Ken'ichi; Miyaji, Reiji; Ogura, Takahiro; Tsubata, Yoko; Sakai, Toshimasa

    The seminar ‘Practice on Manufacturing Technology by Advanced Machine Tools’ for high school students was held at the supporting center for technology education of Gifu University, under the sponsorship of the Japan Society of Mechanical Engineers. This seminar was held, hoping that many students become interested in manufacturing through the experience of the seminar. Operating CNC milling machine and CNC wire-cut electric discharge machine, they made original nameplates. Participants made the program to control CNC machine tools themselves. In this report, some valuable results obtained through such experience are explained.

  7. Knowledge Gained from Good Agricultural Practices Courses for Iowa Growers

    ERIC Educational Resources Information Center

    Shaw, Angela; Strohbehn, Catherine; Naeve, Linda; Domoto, Paul; Wilson, Lester

    2015-01-01

    Good Agricultural Practices (GAP) educational courses provide produce growers with the fundamental information for producing and processing safe produce. To determine the effectiveness of the current 7-hour GAP course provided in Iowa, growers were surveyed before and 7-14 days after the course to determine changes in knowledge and opinions.…

  8. Student Accommodation Projects: A Guide to PFI Contracts. Good Practice.

    ERIC Educational Resources Information Center

    Curtis, Pinsent

    This guide is intended for higher education institutions in England that are about to embark on student residential accommodation projects. It focuses on procurements under the Private Financial Initiative (PFI), a form of Public Private Partnership in the United Kingdom, but other approaches are considered. The guide draws on good practices from…

  9. Safety climate practice in Korean manufacturing industry.

    PubMed

    Baek, Jong-Bae; Bae, Sejong; Ham, Byung-Ho; Singh, Karan P

    2008-11-15

    Safety climate survey was sent to 642 plants in 2003 to explore safety climate practices in the Korean manufacturing plants, especially in hazardous chemical treating plants. Out of 642 plants contacted 195 (30.4%) participated in the surveys. Data were collected by e-mail using SQL-server and mail. The main objective of this study was to explore safety climate practices (level of safety climate and the underlying problems). In addition, the variables that may influence the level of safety climate among managers and workers were explored. The questionnaires developed by health and safety executive (HSE) in the UK were modified to incorporate differences in Korean culture. Eleven important factors were summarized. Internal reliability of these factors was validated. Number of employees in the company varied from less than 30 employees (9.2%) to over 1000 employees (37.4%). Both managers and workers showed generally high level of safety climate awareness. The major underlying problems identified were inadequate health and safety procedures/rules, pressure for production, and rule breaking. The length of employment was a significant contributing factor to the level of safety climate. In this study, participants showed generally high level of safety climate, and length of employment affected the differences in the level of safety climate. Managers' commitment to comply safety rules, procedures, and effective safety education and training are recommended.

  10. Developing a tool for the preparation of GMP audit of pharmaceutical contract manufacturer.

    PubMed

    Linna, Anu; Korhonen, Mirka; Mannermaa, Jukka-Pekka; Airaksinen, Marja; Juppo, Anne Mari

    2008-06-01

    Outsourcing is rapidly growing in the pharmaceutical industry. When the manufacturing activities are outsourced, control of the product's quality has to be maintained. One way to confirm contract manufacturer's GMP (Good Manufacturing Practice) compliance is auditing. Audits can be supported for instance by using GMP questionnaires. The objective of this study was to develop a tool for the audit preparation of pharmaceutical contract manufacturers and to validate its contents by using Delphi method. At this phase of the study the tool was developed for non-sterile finished product contract manufacturers. A modified Delphi method was used with expert panel consisting of 14 experts from pharmaceutical industry, authorities and university. The content validity of the developed tool was assessed by a Delphi questionnaire round. The response rate in Delphi questionnaire round was 86%. The tool consisted of 103 quality items, from which 90 (87%) achieved the pre-defined agreement rate level (75%). Thirteen quality items which did not achieve the pre-defined agreement rate were excluded from the tool. The expert panel suggested only minor changes to the tool. The results show that the content validity of the developed audit preparation tool was good.

  11. National Institutes of Health-Sponsored Clinical Islet Transplantation Consortium Phase 3 Trial: Manufacture of a Complex Cellular Product at Eight Processing Facilities.

    PubMed

    Ricordi, Camillo; Goldstein, Julia S; Balamurugan, A N; Szot, Gregory L; Kin, Tatsuya; Liu, Chengyang; Czarniecki, Christine W; Barbaro, Barbara; Bridges, Nancy D; Cano, Jose; Clarke, William R; Eggerman, Thomas L; Hunsicker, Lawrence G; Kaufman, Dixon B; Khan, Aisha; Lafontant, David-Erick; Linetsky, Elina; Luo, Xunrong; Markmann, James F; Naji, Ali; Korsgren, Olle; Oberholzer, Jose; Turgeon, Nicole A; Brandhorst, Daniel; Chen, Xiaojuan; Friberg, Andrew S; Lei, Ji; Wang, Ling-Jia; Wilhelm, Joshua J; Willits, Jamie; Zhang, Xiaomin; Hering, Bernhard J; Posselt, Andrew M; Stock, Peter G; Shapiro, A M James; Chen, Xiaojuan

    2016-11-01

    Eight manufacturing facilities participating in the National Institutes of Health-sponsored Clinical Islet Transplantation (CIT) Consortium jointly developed and implemented a harmonized process for the manufacture of allogeneic purified human pancreatic islet (PHPI) product evaluated in a phase 3 trial in subjects with type 1 diabetes. Manufacturing was controlled by a common master production batch record, standard operating procedures that included acceptance criteria for deceased donor organ pancreata and critical raw materials, PHPI product specifications, certificate of analysis, and test methods. The process was compliant with Current Good Manufacturing Practices and Current Good Tissue Practices. This report describes the manufacturing process for 75 PHPI clinical lots and summarizes the results, including lot release. The results demonstrate the feasibility of implementing a harmonized process at multiple facilities for the manufacture of a complex cellular product. The quality systems and regulatory and operational strategies developed by the CIT Consortium yielded product lots that met the prespecified characteristics of safety, purity, potency, and identity and were successfully transplanted into 48 subjects. No adverse events attributable to the product and no cases of primary nonfunction were observed. © 2016 by the American Diabetes Association.

  12. National Institutes of Health–Sponsored Clinical Islet Transplantation Consortium Phase 3 Trial: Manufacture of a Complex Cellular Product at Eight Processing Facilities

    PubMed Central

    Balamurugan, A.N.; Szot, Gregory L.; Kin, Tatsuya; Liu, Chengyang; Czarniecki, Christine W.; Barbaro, Barbara; Bridges, Nancy D.; Cano, Jose; Clarke, William R.; Eggerman, Thomas L.; Hunsicker, Lawrence G.; Kaufman, Dixon B.; Khan, Aisha; Lafontant, David-Erick; Linetsky, Elina; Luo, Xunrong; Markmann, James F.; Naji, Ali; Korsgren, Olle; Oberholzer, Jose; Turgeon, Nicole A.; Brandhorst, Daniel; Chen, Xiaojuan; Friberg, Andrew S.; Lei, Ji; Wang, Ling-jia; Wilhelm, Joshua J.; Willits, Jamie; Zhang, Xiaomin; Hering, Bernhard J.; Posselt, Andrew M.; Stock, Peter G.; Shapiro, A.M. James

    2016-01-01

    Eight manufacturing facilities participating in the National Institutes of Health–sponsored Clinical Islet Transplantation (CIT) Consortium jointly developed and implemented a harmonized process for the manufacture of allogeneic purified human pancreatic islet (PHPI) product evaluated in a phase 3 trial in subjects with type 1 diabetes. Manufacturing was controlled by a common master production batch record, standard operating procedures that included acceptance criteria for deceased donor organ pancreata and critical raw materials, PHPI product specifications, certificate of analysis, and test methods. The process was compliant with Current Good Manufacturing Practices and Current Good Tissue Practices. This report describes the manufacturing process for 75 PHPI clinical lots and summarizes the results, including lot release. The results demonstrate the feasibility of implementing a harmonized process at multiple facilities for the manufacture of a complex cellular product. The quality systems and regulatory and operational strategies developed by the CIT Consortium yielded product lots that met the prespecified characteristics of safety, purity, potency, and identity and were successfully transplanted into 48 subjects. No adverse events attributable to the product and no cases of primary nonfunction were observed. PMID:27465220

  13. Cost benefit of investment on quality in pharmaceutical manufacturing: WHO GMP pre- and post-certification of a Nigerian pharmaceutical manufacturer.

    PubMed

    Anyakora, Chimezie; Ekwunife, Obinna; Alozie, Faith; Esuga, Mopa; Ukwuru, Jonathan; Onya, Steve; Nwokike, Jude

    2017-09-18

    Pharmaceutical companies in Africa need to invest in both facilities and quality management systems to achieve good manufacturing practice (GMP) compliance. Compliance to international GMP standards is important to the attainment of World Health Organization (WHO) prequalification. However, most of the local pharmaceutical manufacturing companies may be deterred from investing in quality because of many reasons, ranging from financial constraints to technical capacity. This paper primarily evaluates benefits against the cost of investing in GMP, using a Nigerian pharmaceutical company, Chi Pharmaceuticals Limited, as a case study. This paper also discusses how to drive more local manufacturers to invest in quality to attain GMP compliance; and proffers practical recommendations for local manufacturers who would want to invest in quality to meet ethical and regulatory obligations. The cost benefit of improving the quality of Chi Pharmaceuticals Limited's facilities and system to attain WHO GMP certification for the production of zinc sulfate 20-mg dispersible tablets was calculated by dividing the annual benefits derived from quality improvement interventions by the annual costs of implementing quality improvement interventions, referred to as a benefit-cost ratio (BCR). Cost benefit of obtaining WHO GMP certification for the production of zinc sulfate 20-mg dispersible tablets was 5.3 (95% confidence interval of 5.0-5.5). Investment in quality improvement intervention is cost-beneficial for local manufacturing companies. Governments and regulators in African countries should support pharmaceutical companies striving to invest in quality. Collaboration of local manufacturing companies with global companies will further improve quality. Local pharmaceutical companies should be encouraged to key into development opportunities available for pharmaceutical companies in Africa.

  14. Towards a commercial process for the manufacture of genetically modified T cells for therapy

    PubMed Central

    Kaiser, A D; Assenmacher, M; Schröder, B; Meyer, M; Orentas, R; Bethke, U; Dropulic, B

    2015-01-01

    The recent successes of adoptive T-cell immunotherapy for the treatment of hematologic malignancies have highlighted the need for manufacturing processes that are robust and scalable for product commercialization. Here we review some of the more outstanding issues surrounding commercial scale manufacturing of personalized-adoptive T-cell medicinal products. These include closed system operations, improving process robustness and simplifying work flows, reducing labor intensity by implementing process automation, scalability and cost, as well as appropriate testing and tracking of products, all while maintaining strict adherence to Current Good Manufacturing Practices and regulatory guidelines. A decentralized manufacturing model is proposed, where in the future patients' cells could be processed at the point-of-care in the hospital. PMID:25613483

  15. Lead, mercury, and arsenic in US- and Indian-manufactured Ayurvedic medicines sold via the Internet.

    PubMed

    Saper, Robert B; Phillips, Russell S; Sehgal, Anusha; Khouri, Nadia; Davis, Roger B; Paquin, Janet; Thuppil, Venkatesh; Kales, Stefanos N

    2008-08-27

    Lead, mercury, and arsenic have been detected in a substantial proportion of Indian-manufactured traditional Ayurvedic medicines. Metals may be present due to the practice of rasa shastra (combining herbs with metals, minerals, and gems). Whether toxic metals are present in both US- and Indian-manufactured Ayurvedic medicines is unknown. To determine the prevalence of Ayurvedic medicines available via the Internet containing detectable lead, mercury, or arsenic and to compare the prevalence of toxic metals in US- vs Indian-manufactured medicines and between rasa shastra and non-rasa shastra medicines. A search using 5 Internet search engines and the search terms Ayurveda and Ayurvedic medicine identified 25 Web sites offering traditional Ayurvedic herbs, formulas, or ingredients commonly used in Ayurveda, indicated for oral use, and available for sale. From 673 identified products, 230 Ayurvedic medicines were randomly selected for purchase in August-October 2005. Country of manufacturer/Web site supplier, rasa shastra status, and claims of Good Manufacturing Practices were recorded. Metal concentrations were measured using x-ray fluorescence spectroscopy. Prevalence of medicines with detectable toxic metals in the entire sample and stratified by country of manufacture and rasa shastra status. One hundred ninety-three of the 230 requested medicines were received and analyzed. The prevalence of metal-containing products was 20.7% (95% confidence interval [CI], 15.2%-27.1%). The prevalence of metals in US-manufactured products was 21.7% (95% CI, 14.6%-30.4%) compared with 19.5% (95% CI, 11.3%-30.1%) in Indian products (P = .86). Rasa shastra compared with non-rasa shastra medicines had a greater prevalence of metals (40.6% vs 17.1%; P = .007) and higher median concentrations of lead (11.5 microg/g vs 7.0 microg/g; P = .03) and mercury (20,800 microg/g vs 34.5 microg/g; P = .04). Among the metal-containing products, 95% were sold by US Web sites and 75% claimed Good

  16. Going GLP: Conducting Toxicology Studies in Compliance with Good Laboratory Practices.

    PubMed

    Carroll, Erica Eggers

    2016-01-01

    Good laboratory practice standards are US federal regulations enacted as part of the Federal Insecticide, Fungicide, and Rodenticide Act (40 CFR Part 160), the Toxic Substance Control Act (40 CFR Part 792), and the Good Laboratory Practice for Nonclinical Laboratory Studies (21 CFR Part 58) to support protection of public health in the areas of pesticides, chemicals, and drug investigations in response to allegations of inaccurate data acquisition. Essentially, good laboratory practices (GLPs) are a system of management controls for nonclinical research studies involving animals to ensure the uniformity, consistency, reliability, reproducibility, quality, and integrity of data collected as part of chemical (including pharmaceuticals) tests, from in vitro through acute to chronic toxicity tests. The GLPs were established in the United States in 1978 as a result of the Industrial Bio-Test Laboratory scandal which led to congressional hearings and actions to prevent fraudulent data reporting and collection. Although the establishment of infrastructure for GLPs compliance is labor-intensive and time-consuming, achievement and maintenance of GLP compliance ensures the accuracy of the data collected from each study, which is critical for defending results, advancing science, and protecting human and animal health. This article describes how and why those in the US Army Medical Department responsible for protecting the public health of US Army and other military personnel made the policy decision to have its toxicology laboratory achieve complete compliance with GLP standards, the first such among US Army laboratories. The challenges faced and how they were overcome are detailed.

  17. Emerging good practices for Translatability Assessment (TA) of Patient-Reported Outcome (PRO) measures.

    PubMed

    Acquadro, Catherine; Patrick, Donald L; Eremenco, Sonya; Martin, Mona L; Kuliś, Dagmara; Correia, Helena; Conway, Katrin

    2017-01-01

    This paper presents emerging Good Practices for Translatability Assessment (TA) of Patient-Reported Outcome (PRO) Measures. The ISOQOL Translation and Cultural Adaptation Special Interest Group (TCA-SIG) undertook the review of several TA approaches, with the collaboration of organizations who are involved in conducting TA, and members of the TCA-SIG. The effort led to agreement by the writing group on Good Practices for 1) the terminology to be used in referring to translatability process, 2) the best definition of TA, 3) the methodology that is recommended at each step of the process, 4) the persons involved in TA, 5) the timing of assessment, 6) the review criteria for TA, and 7) the recommendations to be made at the end of the TA process. With input from the TCA-SIG membership and in consultation with experts in the field, these emerging good practices can guide the future use of TA in the development of PROs.

  18. Guidelines on Good Clinical Laboratory Practice

    PubMed Central

    Ezzelle, J.; Rodriguez-Chavez, I. R.; Darden, J. M.; Stirewalt, M.; Kunwar, N.; Hitchcock, R.; Walter, T.; D’Souza, M. P.

    2008-01-01

    A set of Good Clinical Laboratory Practice (GCLP) standards that embraces both the research and clinical aspects of GLP were developed utilizing a variety of collected regulatory and guidance material. We describe eleven core elements that constitute the GCLP standards with the objective of filling a gap for laboratory guidance, based on IND sponsor requirements, for conducting laboratory testing using specimens from human clinical trials. These GCLP standards provide guidance on implementing GLP requirements that are critical for laboratory operations, such as performance of protocol-mandated safety assays, peripheral blood mononuclear cell processing and immunological or endpoint assays from biological interventions on IND-registered clinical trials. The expectation is that compliance with the GCLP standards, monitored annually by external audits, will allow research and development laboratories to maintain data integrity and to provide immunogenicity, safety, and product efficacy data that is repeatable, reliable, auditable and that can be easily reconstructed in a research setting. PMID:18037599

  19. Adaptive governance good practice: Show me the evidence!

    PubMed

    Sharma-Wallace, Lisa; Velarde, Sandra J; Wreford, Anita

    2018-09-15

    -based adaptive governance good practice within and across diverse sectors, issues, and contexts. Copyright © 2018. Published by Elsevier Ltd.

  20. Liberal Arts Colleges and Good Practices in Undergraduate Education: Additional Evidence

    ERIC Educational Resources Information Center

    Seifert, Tricia A.; Pascarella, Ernest T.; Goodman, Kathleen M.; Salisbury, Mark H.; Blaich, Charles F.

    2010-01-01

    Liberal arts colleges have prided themselves on providing students with a quality undergraduate education among a scholarly community who are interested in their holistic development. Past research has found students who attended liberal arts colleges more frequently experienced Chickering and Gamson's (1987, 1991) good practices in undergraduate…

  1. Healthcare associated infection: good practices, knowledge and the locus of control in heatlhcare professionals.

    PubMed

    Taffurelli, Chiara; Sollami, Alfonso; Camera, Carmen; Federa, Francesca; Grandi, Annise; Marino, Marcella; Marrosu, Tiziano; Sarli, Leopoldo

    2017-07-18

      The incidence of Healthcare Associated Infections (HAI) is an important indicator of the quality of care. The behaviors associated with the prevention of infections are not only supported by rational knowledge or motivation, but are mediated by social, emotional and often stereotyped behaviors. The awarness of the good practices related to HAI, may be a factor. Other studies, identify how the perception of the problem in healthcare professionals is often influenced by a tendency towards an external Locus of Control: the patient, the family, the other wards, other care settings. The aim of this study is to investigate the perception of healthcare professionals. In particular they have been measured their  awarness of the good practices, perceptions of the potential contamination level of some commonly used objects, knowledge about the management of invasive devices, Locus of Control.   A cross-sectional correlational design was utilized.  An ad hoc questionnaire was interviewed by 222 health professionals nurses and physicians in a northern hospital of Italy. The percentage of professionals who have attended training courses over the last 5 years was quite high, both for upgrades on HAI (78.7%) and Vascular Catheters (78.8%), while the percentage of professionals who updated on bladder catheterization (59.46%) was lower. The mean  score of good practice awareness towards HAI (5.06), is high. The perception of the potential level of contamination of some devices had a  mean ranging from 4.62 (for the drip) to 5.26 (for the door handle). The average value of the Locus of Control (43.54) indicates that participants demonstrated a value that is midway between External and Internal. The correlation test analysis revealed no significant relationships among professionals'age, knowledge about HAI, or infection related venus catheter. Also, results revealed that there were statistically significant positive relationships between professionals' Good Practices

  2. Factors associated with good TB infection control practices among primary healthcare workers in the Free State Province, South Africa.

    PubMed

    Engelbrecht, Michelle; Janse van Rensburg, André; Kigozi, Gladys; van Rensburg, Hcj Dingie

    2016-11-04

    Despite the availability of TB infection control guidelines, and good levels of healthcare worker knowledge about infection control, often these measures are not well implemented. This study sought to determine the factors associated with healthcare workers' good TB infection control practices in primary health care facilities in the Free State Province, South Africa. A cross-sectional self-administered survey among nurses (n = 202) and facility-based community healthcare workers (n = 34) as well as facility observations were undertaken at all 41 primary health care facilities in a selected district of the Free State Province. The majority of respondents were female (n = 200; 87.7 %) and the average age was 44.19 years (standard deviation ±10.82). Good levels of knowledge were recorded, with 42.8 % (n = 101) having an average score (i.e. 65-79 %) and 31.8 % (n = 75) a good score (i.e. ≥ 80 %). Most respondents (n = 189; 80.4 %) had positive attitudes towards TB infection control practices (i.e. ≥ 80 %). While good TB infection control practices were reported by 72.9 % (n = 161) of the respondents (i.e. ≥75 %), observations revealed this to not necessarily be the case. For every unit increase in attitudes, good practices increased 1.090 times (CI:1.016-1.169). Respondents with high levels of knowledge (≥80 %) were 4.029 (CI: 1.550-10.469) times more likely to have good practices when compared to respondents with poor levels of knowledge (<65 %). The study did not find TB/HIV-related training to be a predictor of good practices. Positive attitudes and good levels of knowledge regarding TB infection control were the main factors associated with good infection control practices. Although many respondents reported good infection control practices - which was somewhat countered by the observations - there are areas that require attention, particularly those related to administrative controls and the use of personal

  3. Do Liberal Arts Colleges Really Foster Good Practices in Undergraduate Education?

    ERIC Educational Resources Information Center

    Pascarella, Ernest T.; Cruce, Ty M.; Wolniak, Gregory C.; Blaich, Charles F.

    2004-01-01

    Researchers estimated the net effects of liberal arts colleges on 19 measures of good practices in undergraduate education grouped into seven categories. Analyses of 3-year longitudinal data from five liberal arts colleges, four research universities, and seven regional universities were conducted. Net of a battery of student precollege…

  4. Values Education as Good Practice Pedagogy: Evidence from Australian Empirical Research

    ERIC Educational Resources Information Center

    Lovat, Terence

    2017-01-01

    This article focuses on the Australian Government's Values Education Program and, within its context, the "Values Education Good Practice Schools Project" (VEGPSP) Reports and the "Project to Test and Measure the Impact of Values Education on Student Effects and School Ambience," funded federally from 2003 to 2010. Findings…

  5. Identification of Good Practices in the Implementation of Innovative Learning Methodologies

    ERIC Educational Resources Information Center

    Lincaru, Cristina; Ciuca, Vasilica; Grecu, Liliana; Atanasiu, Draga; Dragoiu, Codruta

    2011-01-01

    We intend to present the partial issues resulted from the development of the European Project DeInTRA "cooperation for innovative training methodologies deployment in the European Labour Market"--Stage 4: Identification of good practices in the implementation of innovative learning methodologies. This project is included into the…

  6. 21 CFR 809.20 - General requirements for manufacturers and producers of in vitro diagnostic products.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... producers of in vitro diagnostic products. 809.20 Section 809.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN... producers of in vitro diagnostic products. (a) [Reserved] (b) Compliance with good manufacturing practices...

  7. 21 CFR 809.20 - General requirements for manufacturers and producers of in vitro diagnostic products.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... producers of in vitro diagnostic products. 809.20 Section 809.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN... producers of in vitro diagnostic products. (a) [Reserved] (b) Compliance with good manufacturing practices...

  8. The relationship among the resiliency practices in supply chain, financial performance, and competitive advantage in manufacturing firms in Indonesia and Sierra Leone

    NASA Astrophysics Data System (ADS)

    Musa, I.; Nyoman Pujawan, I.

    2018-04-01

    Current supply chain management (SCM) has become a potentially treasured way of safeguarding competitive advantage and improving organizational performance since competition is no longer between organizations, but among supply chains. This research conceptualizes and develops four resiliency practices (Flexibility, Redundancy, Collaboration and Agility) and tests the relationships between organizations’ financial performance and competitive advantage in manufacturing firms. The study involves manufacturing firms in Indonesia and Sierra Leone. The study used stratified random sampling to pick a sample size of 95 manufacturing firms, which represented different industrial sectors. The respondents were mainly managers of different manufacturing companies. The relationships proposed in the conceptual framework were tested using correlation analysis. The results indicate that higher levels of resilience practices in manufacturing firms can lead to enhanced competitive advantage and improved financial performance.

  9. Prevention of occupational injuries: Evidence for effective good practices in foundries.

    PubMed

    Porru, Stefano; Calza, Stefano; Arici, Cecilia

    2017-02-01

    Occupational injuries are a relevant research and practical issue. However, intervention studies evaluating the effectiveness of workplace injury prevention programs are seldom performed. The effectiveness of a multifaceted intervention aimed at reducing occupational injury rates (incidence/employment-based=IR, frequency/hours-based=FR, severity=SR) was evaluated between 2008 and 2013 in 29 Italian foundries (22 ferrous; 7 non-ferrous; 3,460 male blue collar workers/year) of varying sizes. Each foundry established an internal multidisciplinary prevention team for risk assessment, monitoring and prevention of occupational injuries, involving employers, occupational physicians, safety personnel, workers' representatives, supervisors. Targets of intervention were workers, equipment, organization, workplace, job tasks. An interrupted time series (ITS) design was applied. 4,604 occupational injuries and 83,156 lost workdays were registered between 2003 and 2013. Statistical analysis showed, after intervention, a reduction of all injury rates (-26% IR, -15% FR, -18% SR) in ferrous foundries and of SR (-4%) in non-ferrous foundries. A significant (p=0.021) 'step-effect' was shown for IR in ferrous foundries, independent of secular trends (p<0.001). Sector-specific benchmarks for all injury rates were developed separately for ferrous and non-ferrous foundries. Strengths of the study were: ITS design, according to standardized quality criteria (i.e., at least three data points before and three data points after intervention; clearly defined intervention point); pragmatic approach, with good external validity; promotion of effective good practices. Main limitations were the non-randomized nature and a medium length post-intervention period. In conclusion, a multifaceted, pragmatic and accountable intervention is effective in reducing the burden of occupational injuries in small-, medium- and large-sized foundries. Practical Applications: The study poses the basis for

  10. A Rapid Assessment Tool for affirming good practice in midwifery education programming.

    PubMed

    Fullerton, Judith T; Johnson, Peter; Lobe, Erika; Myint, Khine Haymar; Aung, Nan Nan; Moe, Thida; Linn, Nay Aung

    2016-03-01

    to design a criterion-referenced assessment tool that could be used globally in a rapid assessment of good practices and bottlenecks in midwifery education programs. a standard tool development process was followed, to generate standards and reference criteria; followed by external review and field testing to document psychometric properties. review of standards and scoring criteria were conducted by stakeholders around the globe. Field testing of the tool was conducted in Myanmar. eleven of Myanmar׳s 22 midwifery education programs participated in the assessment. the clinimetric tool was demonstrated to have content validity and high inter-rater reliability in use. a globally validated tool, and accompanying user guide and handbook are now available for conducting rapid assessments of compliance with good practice criteria in midwifery education programming. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

  11. Good quantification practices of flavours and fragrances by mass spectrometry.

    PubMed

    Begnaud, Frédéric; Chaintreau, Alain

    2016-10-28

    Over the past 15 years, chromatographic techniques with mass spectrometric detection have been increasingly used to monitor the rapidly expanded list of regulated flavour and fragrance ingredients. This trend entails a need for good quantification practices suitable for complex media, especially for multi-analytes. In this article, we present experimental precautions needed to perform the analyses and ways to process the data according to the most recent approaches. This notably includes the identification of analytes during their quantification and method validation, when applied to real matrices, based on accuracy profiles. A brief survey of application studies based on such practices is given.This article is part of the themed issue 'Quantitative mass spectrometry'. © 2016 The Authors.

  12. Examples of Holistic Good Practices in Promoting and Protecting Mental Health in the Workplace: Current and Future Challenges.

    PubMed

    Sivris, Kelly C; Leka, Stavroula

    2015-12-01

    While attention has been paid to physical risks in the work environment and the promotion of individual employee health, mental health protection and promotion have received much less focus. Psychosocial risk management has not yet been fully incorporated in such efforts. This paper presents good practices in promoting mental health in the workplace in line with World Health Organization (WHO) guidance by identifying barriers, opportunities, and the way forward in this area. Semistructured interviews were conducted with 17 experts who were selected on the basis of their knowledge and expertise in relation to good practice identified tools. Interviewees were asked to evaluate the approaches on the basis of the WHO model for healthy workplaces. The examples of good practice for Workplace Mental Health Promotion (WMHP) are in line with the principles and the five keys of the WHO model. They support the third objective of the WHO comprehensive mental health action plan 2013-2020 for multisectoral implementation of WMHP strategies. Examples of good practice include the engagement of all stakeholders and representatives, science-driven practice, dissemination of good practice, continual improvement, and evaluation. Actions to inform policies/legislation, promote education on psychosocial risks, and provide better evidence were suggested for higher WMHP success. The study identified commonalities in good practice approaches in different countries and stressed the importance of a strong policy and enforcement framework as well as organizational responsibility for WMHP. For progress to be achieved in this area, a holistic and multidisciplinary approach was unanimously suggested as a way to successful implementation.

  13. Examples of Holistic Good Practices in Promoting and Protecting Mental Health in the Workplace: Current and Future Challenges

    PubMed Central

    Sivris, Kelly C.; Leka, Stavroula

    2015-01-01

    Background While attention has been paid to physical risks in the work environment and the promotion of individual employee health, mental health protection and promotion have received much less focus. Psychosocial risk management has not yet been fully incorporated in such efforts. This paper presents good practices in promoting mental health in the workplace in line with World Health Organization (WHO) guidance by identifying barriers, opportunities, and the way forward in this area. Methods Semistructured interviews were conducted with 17 experts who were selected on the basis of their knowledge and expertise in relation to good practice identified tools. Interviewees were asked to evaluate the approaches on the basis of the WHO model for healthy workplaces. Results The examples of good practice for Workplace Mental Health Promotion (WMHP) are in line with the principles and the five keys of the WHO model. They support the third objective of the WHO comprehensive mental health action plan 2013–2020 for multisectoral implementation of WMHP strategies. Examples of good practice include the engagement of all stakeholders and representatives, science-driven practice, dissemination of good practice, continual improvement, and evaluation. Actions to inform policies/legislation, promote education on psychosocial risks, and provide better evidence were suggested for higher WMHP success. Conclusion The study identified commonalities in good practice approaches in different countries and stressed the importance of a strong policy and enforcement framework as well as organizational responsibility for WMHP. For progress to be achieved in this area, a holistic and multidisciplinary approach was unanimously suggested as a way to successful implementation. PMID:26929841

  14. Commentary on the MID3 Good Practices Paper.

    PubMed

    Manolis, Efthymios; Brogren, Jacob; Cole, Susan; Hay, Justin L; Nordmark, Anna; Karlsson, Kristin E; Lentz, Frederike; Benda, Norbert; Wangorsch, Gaby; Pons, Gerard; Zhao, Wei; Gigante, Valeria; Serone, Francesca; Standing, Joseph F; Dokoumetzidis, Aris; Vakkilainen, Juha; van den Heuvel, Michiel; Mangas Sanjuan, Victor; Taminiau, Johannes; Kerwash, Essam; Khan, David; Musuamba, Flora Tshinanu; Skottheim Rusten, Ine

    2017-07-01

    During the last 10 years the European Medicines Agency (EMA) organized a number of workshops on modeling and simulation, working towards greater integration of modeling and simulation (M&S) in the development and regulatory assessment of medicines. In the 2011 EMA - European Federation of Pharmaceutical Industries and Associations (EFPIA) Workshop on Modelling and Simulation, European regulators agreed to the necessity to build expertise to be able to review M&S data provided by companies in their dossier. This led to the establishment of the EMA Modelling and Simulation Working Group (MSWG). Also, there was agreement reached on the need for harmonization on good M&S practices and for continuing dialog across all parties. The MSWG acknowledges the initiative of the EFPIA Model-Informed Drug Discovery and Development (MID3) group in promoting greater consistency in practice, application, and documentation of M&S and considers the paper is an important contribution towards achieving this objective. © 2017 The Authors CPT: Pharmacometrics & Systems Pharmacology published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics.

  15. Good Laboratory Practices of Materials Testing at NASA White Sands Test Facility

    NASA Technical Reports Server (NTRS)

    Hirsch, David; Williams, James H.

    2005-01-01

    An approach to good laboratory practices of materials testing at NASA White Sands Test Facility is presented. The contents include: 1) Current approach; 2) Data analysis; and 3) Improvements sought by WSTF to enhance the diagnostic capability of existing methods.

  16. Coupons and advertising in markets for addictive goods: do cigarette manufacturers react to known future tax increases?

    PubMed

    Lillard, Dean R; Sfekas, Andrew

    2005-01-01

    We develop and test a pricing model for a monopolist that sells an addictive good. The model illustrates the conditions under which a monopolist lowers the price he charges youth when a future tax is imposed. Using household survey data, we investigate whether individuals use "cents-off" coupons in a way consistent with the price discrimination implied by the model. We find evidence that all smokers, not just the young, are more likely to use coupons prior to a tax increase if they are exposed to more advertising. With our data we cannot test whether cigarette manufacturers selectively offer youth price discounts in other ways.

  17. Good practices of publishing AYUSH research: A practical checklist for authors.

    PubMed

    Patwardhan, Kishor; Tillu, Girish; Jadhav, Priyanka M

    Since its inception, Journal of Ayurveda and Integrative Medicine (J-AIM) has been constantly striving to create an environment that inculcates and strengthens "Good Publication Practices (GPP)" amongst students, practitioners and researchers in AYUSH community. The J-AIM has been doing this in the form of conducting workshops on scientific writing and research methods on different platforms. This article is based on our experiences and varied discussions that we have had with students, teachers, practitioners and researchers during these interactive sessions, and is intended at addressing the gap that prevails in the domain. The need for such awareness is felt even more strongly ever since the Beall's list of predatory journals has been unpublished. This article tries to fill the void this disappearance has created. We analyze the current scenario of AYUSH publications, enumerate the common perceptions and concerns among the workers in the field, and consider the periodicals where the doctoral and postgraduate level of Ayurveda research works are being published at present. The article also presents a practical checklist that will be helpful for students and teachers to refer authentic resources and submit their work to an appropriate scholarly journal. Copyright © 2017 Transdisciplinary University, Bangalore and World Ayurveda Foundation. Published by Elsevier B.V. All rights reserved.

  18. Lead, Mercury, and Arsenic in US- and Indian-Manufactured Ayurvedic Medicines Sold via the Internet

    PubMed Central

    Saper, Robert B.; Phillips, Russell S.; Sehgal, Anusha; Khouri, Nadia; Davis, Roger B.; Paquin, Janet; Thuppil, Venkatesh; Kales, Stefanos N.

    2009-01-01

    Context Lead, mercury, and arsenic have been detected in a substantial proportion of Indian-manufactured traditional Ayurvedic medicines. Metals may be present due to the practice of rasa shastra (combining herbs with metals, minerals, and gems). Whether toxic metals are present in both US- and Indian-manufactured Ayurvedic medicines is unknown. Objectives To determine the prevalence of Ayurvedic medicines available via the Internet containing detectable lead, mercury, or arsenic and to compare the prevalence of toxic metals in US- vs Indian-manufactured medicines and between rasa shastra and non–rasa shastra medicines. Design A search using 5 Internet search engines and the search terms Ayurveda and Ayurvedic medicine identified 25 Web sites offering traditional Ayurvedic herbs, formulas, or ingredients commonly used in Ayurveda, indicated for oral use, and available for sale. From 673 identified products, 230 Ayurvedic medicines were randomly selected for purchase in August–October 2005. Country of manufacturer/Web site supplier, rasa shastra status, and claims of Good Manufacturing Practices were recorded. Metal concentrations were measured using x-ray fluorescence spectroscopy. Main Outcome Measures Prevalence of medicines with detectable toxic metals in the entire sample and stratified by country of manufacture and rasa shastra status. Results One hundred ninety-three of the 230 requested medicines were received and analyzed. The prevalence of metal-containing products was 20.7% (95% confidence interval [CI], 15.2%–27.1%). The prevalence of metals in US-manufactured products was 21.7% (95% CI, 14.6%–30.4%) compared with 19.5% (95% CI, 11.3%–30.1%) in Indian products (P=.86). Rasa shastra compared with non–rasa shastra medicines had a greater prevalence of metals (40.6% vs 17.1%; P=.007) and higher median concentrations of lead (11.5 μg/g vs 7.0 μg/g; P=.03) and mercury (20 800 μg/g vs 34.5 μg/g; P=.04). Among the metal-containing products, 95

  19. Analysis of good practice of public health Emergency Operations Centers.

    PubMed

    Xu, Min; Li, Shi-Xue

    2015-08-01

    To study the public health Emergency Operations Centers (EOCs)in the US, the European Union, the UK and Australia, and summarize the good practice for the improvement of National Health Emergency Response Command Center in Chinese National Health and Family Planning Commission. Literature review was conducted to explore the EOCs of selected countries. The study focused on EOC function, organizational structure, human resources and information management. The selected EOCs had the basic EOC functions of coordinating and commanding as well as the public health related functions such as monitoring the situation, risk assessment, and epidemiological briefings. The organizational structures of the EOCs were standardized, scalable and flexible. Incident Command System was the widely applied organizational structure with a strong preference. The EOCs were managed by a unit of emergency management during routine time and surge staff were engaged upon emergencies. The selected EOCs had clear information management framework including information collection, assessment and dissemination. The performance of National Health Emergency Response Command Center can be improved by learning from the good practice of the selected EOCs, including setting clear functions, standardizing the organizational structure, enhancing the human resource capacity and strengthening information management. Copyright © 2015 Hainan Medical College. Production and hosting by Elsevier B.V. All rights reserved.

  20. Personal Transferable Skills in Higher Education: The Problems of Implementing Good Practice.

    ERIC Educational Resources Information Center

    Drummond, Ian; Nixon, Iain; Wiltshire, John

    1998-01-01

    Promotion of effective development of personal transferable skills has had limited success in British higher education. Difficulties inherent in implementing established good practice include institutional inertia, issues of academic freedom, resources, high levels of commitment to a particular discipline, and modularization. (SK)

  1. Developing the Teaching Material Using ATV Cooperated with Student on Manufacturing Practice

    NASA Astrophysics Data System (ADS)

    Tsukamoto, Kimihide; Yamamoto, Keiichiro; Ueno, Takayuki; Imazato, Tatsunari; Sakamoto, Hidetoshi

    Recently, a number of students have entered the college of technology with no experience of dismantling and assembling of even an easy machine (including toys) . It is necessary to study the correct usage of tools for lower grade students as a base of the technical education for dismantling and assembling of the machine. However, enough understanding has not been obtained though the usage of the tool is trained for first grade students. So, we executed the development on the teaching text and material of student practice curriculum, which is attractive subject of all-terrain vehicle [ATV]‧s dismantling and assembling for lower grade students. This practice make the student learn both how to use the tools and the steer mechanism of car through the dismantling and assembling of ATV. The text book and sub-teaching materials of this practice curriculum were created in cooperation with fifth grade students as graduation research. As a result, an effective teaching and learning text and sub-teaching materials in manufacturing practice could be developed from student‧s point of view.

  2. Electron beam curing — taking good ideas to the manufacturing floor

    NASA Astrophysics Data System (ADS)

    Saunders, C.; Lopata, V.; Barnard, J.; Stepanik, T.

    2000-03-01

    Acsion is exploiting several emerging electron beam EB applications ranging from composite curing and repair to viscose manufacturing. EB curing of composite structures offers several advantages: significantly reduced curing times; improvements in part quality and performance; reduced environmental and health concerns; improvements in material handling; and reduced overall manufacturing costs compared to thermal curing. The aerospace industry is developing EB technology in all of their market sectors, including military aviation and space products. Some specific products include cryogenic fuel tanks, improved canopy frames for jet aircraft, and the all-composite military aircraft. This paper discusses each of these opportunities.

  3. Energy 101: Clean Energy Manufacturing

    ScienceCinema

    None

    2018-01-16

    Most of us have a basic understanding of manufacturing. It's how we convert raw materials, components, and parts into finished goods that meet our essential needs and make our lives easier. But what about clean energy manufacturing? Clean energy and advanced manufacturing have the potential to rejuvenate the U.S. manufacturing industry and open pathways to increased American competitiveness. Watch this video to learn more about this exciting movement and to see some of these innovations in action.

  4. Computer ergonomics: the medical practice guide to developing good computer habits.

    PubMed

    Hills, Laura

    2011-01-01

    Medical practice employees are likely to use computers for at least some of their work. Some sit several hours each day at computer workstations. Therefore, it is important that members of your medical practice team develop good computer work habits and that they know how to align equipment, furniture, and their bodies to prevent strain, stress, and computer-related injuries. This article delves into the field of computer ergonomics-the design of computer workstations and work habits to reduce user fatigue, discomfort, and injury. It describes practical strategies medical practice employees can use to improve their computer work habits. Specifically, this article describes the proper use of the computer workstation chair, the ideal placement of the computer monitor and keyboard, and the best lighting for computer work areas and tasks. Moreover, this article includes computer ergonomic guidelines especially for bifocal and progressive lens wearers and offers 10 tips for proper mousing. Ergonomically correct posture, movements, positioning, and equipment are all described in detail to enable the frequent computer user in your medical practice to remain healthy, pain-free, and productive.

  5. [Implementation of good quality and safety practices. Descriptive study in a occupational mutual health centre].

    PubMed

    Manzanera, R; Plana, M; Moya, D; Ortner, J; Mira, J J

    2016-01-01

    To describe the level of implementation of quality and safety good practice elements in a Mutual Society health centre. A Cross-sectional study was conducted to assess the level of implementation of good practices using a questionnaire. Some quality dimensions were also assessed (scale 0 to 10) by a set of 87 quality coordinators of health centres and a random sample of 54 healthcare professionals working in small centres. Seventy quality coordinators and 27 professionals replied (response rates 80% and 50%, respectively. There were no differences in the assessment of quality attributes between both groups. They identified as areas for improvement: use of practice guidelines (7.6/10), scientific and technical skills (7.5/10), and patient satisfaction (7.7/10). Availability and accessibility to clinical reports, informed consent, availability of hydro-alcoholic solution, and to record allergies, were considered of high importance to be implemented, with training and research, improvements in equipment and technology plans, adherence to clinical practice guidelines and the preparation of risk maps, being of less importance. The good practices related to equipment and resources have a higher likelihood to be implemented, meanwhile those related to quality and safety attitudes have more barriers before being implemented. The mutual has a similar behaviour than other healthcare institutions. Copyright © 2015 SECA. Published by Elsevier Espana. All rights reserved.

  6. Creating Opportunities: Good Practice in Small Business Training for Australian Rural Women.

    ERIC Educational Resources Information Center

    Simpson, Lyn; Daws, Leonie; Wood, Leanne

    2002-01-01

    To overcome barriers to participation in small business training faced by rural Australian women, training needs and delivery issues were identified and a good practice matrix was developed with the following components: marketing, content, delivery, support, impact, and innovation. Underlying principles included unique needs, diversity, use of…

  7. 9 CFR 147.26 - Procedures for establishing isolation and maintaining sanitation and good management practices...

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... and maintaining sanitation and good management practices for the control of Salmonella and Mycoplasma... management practices for the control of Salmonella and Mycoplasma infections. (a) The following procedures...) Allow no visitors except under controlled conditions to minimize the introduction of Salmonella and...

  8. Securing the Adoption of Good Practice in Scotland's Colleges. A Report by HM Inspectors of Education for the Scottish Funding Council

    ERIC Educational Resources Information Center

    Her Majesty's Inspectorate of Education, 2006

    2006-01-01

    The purpose of this report is to describe the main mechanisms currently in use in Scotland's colleges to ensure that the adoption of good practice actually happens. It investigates how colleges identify and promote good practice in their own institutions; how they develop strategies and processes to ensure good practice is shared, adopted and…

  9. Taking personal responsibility: Nurses' and assistant nurses' experiences of good nursing practice in psychiatric inpatient care.

    PubMed

    Gabrielsson, Sebastian; Sävenstedt, Stefan; Olsson, Malin

    2016-10-01

    Therapeutic nurse-patient relationships are considered essential for good nursing practice in psychiatric inpatient care. Previous research suggests that inpatient care fails to fulfil patients' expectations in this regard, and that nurses might experience the reality of inpatient care as an obstruction. The aim of the present study was to explore nurses' and assistant nurses' experiences of good nursing practice in the specific context of psychiatric inpatient care. Qualitative interviews were conducted with 12 skilled, relationship-oriented nurses and assistant nurses in order to explore their experiences with nursing practice related to psychiatric inpatient care. Interviews were transcribed and analysed using an interpretive descriptive approach. Findings describe good nursing practice as a matter of nurses and assistant nurses taking personal responsibility for their actions and for the individual patient as a person. Difficulties in providing dignified nursing care and taking personal responsibility cause them to experience feelings of distress and frustration. Shared values and nursing leadership supports being moral and treating patients with respect, having enough time supports being present and connecting with patients, and working as a part of a competent team with critical daily discussions and diversity supports being confident and building trust. The findings suggest that taking personal responsibility is integral to good nursing practice. If unable to improve poor circumstances, nurses might be forced to promote their own survival by refuting or redefining their responsibility. Nurses need to prioritize being with patients and gain support in shaping their own nursing practice. Nursing leadership should provide moral direction and defend humanistic values. © 2016 Australian College of Mental Health Nurses Inc.

  10. Using Performance Analysis for Training in an Organization Implementing ISO-9000 Manufacturing Practices: A Case Study.

    ERIC Educational Resources Information Center

    Kunneman, Dale E.; Sleezer, Catherine M.

    2000-01-01

    This case study examines the application of the Performance Analysis for Training (PAT) Model in an organization that was implementing ISO-9000 (International Standards Organization) processes for manufacturing practices. Discusses the interaction of organization characteristics, decision maker characteristics, and analyst characteristics to…

  11. A New Survey of "Good Practices" Could Be an Alternative to Rankings.

    ERIC Educational Resources Information Center

    Gose, Ben

    1999-01-01

    A new national survey, developed by professionals in higher education assessment, seeks to measure the extent to which colleges use "good practices" that encourage learning. Creators of the National Survey of Student Engagement will study undergraduates at 750 colleges over three years to establish benchmarks for different institution…

  12. 9 CFR 147.26 - Procedures for establishing isolation and maintaining sanitation and good management practices...

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... rodent population and other pests under control; (6) Tailor vaccination programs to needs of farm and... and maintaining sanitation and good management practices for the control of Salmonella and Mycoplasma... management practices for the control of Salmonella and Mycoplasma infections. (a) The following procedures...

  13. 9 CFR 147.26 - Procedures for establishing isolation and maintaining sanitation and good management practices...

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... rodent population and other pests under control; (6) Tailor vaccination programs to needs of farm and... and maintaining sanitation and good management practices for the control of Salmonella and Mycoplasma... management practices for the control of Salmonella and Mycoplasma infections. (a) The following procedures...

  14. 9 CFR 147.26 - Procedures for establishing isolation and maintaining sanitation and good management practices...

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... rodent population and other pests under control; (6) Tailor vaccination programs to needs of farm and... and maintaining sanitation and good management practices for the control of Salmonella and Mycoplasma... management practices for the control of Salmonella and Mycoplasma infections. (a) The following procedures...

  15. Application of Hazard Analysis Critical Control Point in the local manufacture of ready-to-use therapeutic foods (RUTFs).

    PubMed

    Henry, C Jeya K; Xin, Janice Lim Wen

    2014-06-01

    The local manufacture of ready-to-use therapeutic foods (RUTFs) is increasing, and there is a need to develop methods to ensure their safe production. We propose the application of Hazard Analysis Critical Control Point (HACCP) principles to achieve this goal. The basic principles of HACCP in the production of RUTFs are outlined. It is concluded that the implementation of an HACCP system in the manufacture of RUTFs is not only feasible but also attainable. The introduction of good manufacturing practices, coupled with an effective HACCP system, will ensure that RUTFs are produced in a cost-effective, safe, and hygienic manner.

  16. Advances in participatory occupational health aimed at good practices in small enterprises and the informal sector.

    PubMed

    Kogi, Kazutaka

    2006-01-01

    Participatory programmes for occupational risk reduction are gaining importance particularly in small workplaces in both industrially developing and developed countries. To discuss the types of effective support, participatory steps commonly seen in our "work improvement-Asia" network are reviewed. The review covered training programmes for small enterprises, farmers, home workers and trade union members. Participatory steps commonly focusing on low-cost good practices locally achieved have led to concrete improvements in multiple technical areas including materials handling, workstation ergonomics, physical environment and work organization. These steps take advantage of positive features of small workplaces in two distinct ways. First, local key persons are ready to accept local good practices conveyed through personal, informal approaches. Second, workers and farmers are capable of understanding technical problems affecting routine work and taking flexible actions leading to solving them. This process is facilitated by the use of locally adjusted training tools such as local good examples, action checklists and group work methods. It is suggested that participatory occupational health programmes can work in small workplaces when they utilize low-cost good practices in a flexible manner. Networking of these positive experiences is essential.

  17. Manufacture of tumor- and virus-specific T lymphocytes for adoptive cell therapies

    PubMed Central

    Wang, X; Rivière, I

    2015-01-01

    Adoptive transfer of tumor-infiltrating lymphocytes (TILs) and genetically engineered T lymphocytes expressing chimeric antigen receptors (CARs) or conventional alpha/beta T-cell receptors (TCRs), collectively termed adoptive cell therapy (ACT), is an emerging novel strategy to treat cancer patients. Application of ACT has been constrained by the ability to isolate and expand functional tumor-reactive T cells. The transition of ACT from a promising experimental regimen to an established standard of care treatment relies largely on the establishment of safe, efficient, robust and cost-effective cell manufacturing protocols. The manufacture of cellular products under current good manufacturing practices (cGMPs) has a critical role in the process. Herein, we review current manufacturing methods for the large-scale production of clinical-grade TILs, virus-specific and genetically modified CAR or TCR transduced T cells in the context of phase I/II clinical trials as well as the regulatory pathway to get these complex personalized cellular products to the clinic. PMID:25721207

  18. Manufacture of tumor- and virus-specific T lymphocytes for adoptive cell therapies.

    PubMed

    Wang, X; Rivière, I

    2015-03-01

    Adoptive transfer of tumor-infiltrating lymphocytes (TILs) and genetically engineered T lymphocytes expressing chimeric antigen receptors (CARs) or conventional alpha/beta T-cell receptors (TCRs), collectively termed adoptive cell therapy (ACT), is an emerging novel strategy to treat cancer patients. Application of ACT has been constrained by the ability to isolate and expand functional tumor-reactive T cells. The transition of ACT from a promising experimental regimen to an established standard of care treatment relies largely on the establishment of safe, efficient, robust and cost-effective cell manufacturing protocols. The manufacture of cellular products under current good manufacturing practices (cGMPs) has a critical role in the process. Herein, we review current manufacturing methods for the large-scale production of clinical-grade TILs, virus-specific and genetically modified CAR or TCR transduced T cells in the context of phase I/II clinical trials as well as the regulatory pathway to get these complex personalized cellular products to the clinic.

  19. Manufacturing of biodrugs: need for harmonization in regulatory standards.

    PubMed

    Sahoo, Niharika; Choudhury, Koel; Manchikanti, Padmavati

    2009-01-01

    Biodrugs (biologics) are much more complex than chemically synthesized drugs because of their structural heterogeneity and interactions within a given biologic system. The manufacturing process in the biodrug industry varies with each type of molecule and is far more elaborate and stringent due to the use of living organisms and complex substrates. Product purity and altered structural characteristics leading to potential immunogenicity have often been of concern when establishing quality and safety in the use of biodrugs. Regulatory compliance in manufacturing and commercialization of biodrugs involves quality control, quality assurance, and batch documentation. Many factors such as host cell development, cell bank establishment, cell culture, protein production, purification, analysis, formulation, storage, and handling are critical for ensuring the purity, activity, and safety of the finished product. Good Manufacturing Practice (GMP) for biodrugs has been developed in certain regions such as the EU, US, and Japan. Due to differences in manufacturing methods and systems, product-specific GMP guidelines are evolving. In general, there are variations in GMP guidelines between countries, which lead to difficulty for the manufacturers in conforming to different standards, thus entailing delays in the commercialization of biodrugs. There is a need to develop a unified regulatory guideline for biodrug manufacturing across various countries, which would be helpful in the marketing of products and trade. This review deals with the comparative framework and analysis of GMP regulation of biodrugs.

  20. Paradigms for environmentally conscious manufacturing

    NASA Astrophysics Data System (ADS)

    Edinbarough, Immanuel A.; Wells, Wayne E.

    2004-12-01

    There are several stories involving the industries that pledge themselves for the environmentally conscious manufacturing practices. Paradigms for environmentally conscious manufacturing are associated with one of the aspects of environmental quality, protection, resource management, commitment or sustainability. The engineering rules of thumb that can easily be adopted by aspiring companies need identification. The underlying thread that unifies the efforts of environmentally conscious manufacturing companies, in offering the environmentally safe products to the world, is grouped and presented in the paper as paradigms for successful practices. The various ways in which a start up company, that wants to excel in environmentally conscious manufacturing, can position itself based on the paradigms is also discussed in the paper.

  1. Practical Strategies for Integrating Final Ecosystem Goods and Services into Community Decision-Making.

    EPA Science Inventory

    The concept of Final Ecosystem Goods and Services (FEGS) explicitly connects ecosystem services to the people that benefit from them. This report presents a number of practical strategies for incorporating FEGS, and more broadly ecosystem services, into the decision-making proces...

  2. [Good professional practices of French CICs - version # 2].

    PubMed

    Chevassus, Hugues; Duchesne, Charlène; Sailly, Annabelle; Vigouroux, Céline; Foulon, Christine; Kubiak, Christine; Binquet, Christine; Felin, Alexandra Lamotte; Chaud, Pascal; Thalamas, Claire; Cornu, Catherine

    2017-10-01

    French clinical investigation centers (CICs) are academic platforms dedicated to clinical research. The QUALI-CIC working group helps to improve and harmonize practices within the CIC network. After some years of implementation, the manual of good professional practices of CICs (MGPP CIC) completed in 2010, needed to be revised to best fit with the large panel of CIC activities. The aim was also to make it more accurate and to reinforce requirements about participants safety and data security. In its second version published in the present article, the MGPP CIC includes 255 items divided into 15 chapters. An explanatory document, currently being drafted, will complete the manual to facilitate its implementation. Copyright © 2017 Société française de pharmacologie et de thérapeutique. Published by Elsevier Masson SAS. All rights reserved.

  3. Establishing Good Practices for Exposure–Response Analysis of Clinical Endpoints in Drug Development

    PubMed Central

    Overgaard, RV; Ingwersen, SH; Tornøe, CW

    2015-01-01

    This tutorial aims at promoting good practices for exposure–response (E-R) analyses of clinical endpoints in drug development. The focus is on practical aspects of E-R analyses to assist modeling scientists with a process of performing such analyses in a consistent manner across individuals and projects and tailored to typical clinical drug development decisions. This includes general considerations for planning, conducting, and visualizing E-R analyses, and how these are linked to key questions. PMID:26535157

  4. Perceptions of Science Teachers on Implementation of Seven Principles for Good Practice in Education by Chickering and Gamson in Courses

    ERIC Educational Resources Information Center

    Ugras, Mustafa; Asiltürk, Erol

    2018-01-01

    The present study aimed to determine the perceptions of science teachers on the implementation of the seven principles for good practice in education by Chickering and Gamson in their courses. Seven principles for good science education were used as a data collection tool in the survey. "The seven principles for good practice in science…

  5. CHRODIS criteria applied to the MASK (MACVIA-ARIA Sentinel NetworK) Good Practice in allergic rhinitis: a SUNFRAIL report.

    PubMed

    Bousquet, J; Onorato, G L; Bachert, C; Barbolini, M; Bedbrook, A; Bjermer, L; de Sousa, J Correia; Chavannes, N H; Cruz, A A; De Manuel Keenoy, E; Devillier, P; Fonseca, J; Hun, S; Kostka, T; Hellings, P W; Illario, M; Ivancevich, J C; Larenas-Linnemann, D; Millot-Keurinck, J; Ryan, D; Samolinski, B; Sheikh, A; Yorgancioglu, A; Agache, I; Arnavielhe, S; Bewick, M; Annesi-Maesano, I; Anto, J M; Bergmann, K C; Bindslev-Jensen, C; Bosnic-Anticevich, S; Bouchard, J; Caimmi, D P; Camargos, P; Canonica, G W; Cardona, V; Carriazo, A M; Cingi, C; Colgan, E; Custovic, A; Dahl, R; Demoly, P; De Vries, G; Fokkens, W J; Fontaine, J F; Gemicioğlu, B; Guldemond, N; Gutter, Z; Haahtela, T; Hellqvist-Dahl, B; Jares, E; Joos, G; Just, J; Khaltaev, N; Keil, T; Klimek, L; Kowalski, M L; Kull, I; Kuna, P; Kvedariene, V; Laune, D; Louis, R; Magnan, A; Malva, J; Mathieu-Dupas, E; Melén, E; Menditto, E; Morais-Almeida, M; Mösges, R; Mullol, J; Murray, R; Neffen, H; O'Hehir, R; Palkonen, S; Papadopoulos, N G; Passalacqua, G; Pépin, J L; Portejoie, F; Price, D; Pugin, B; Raciborski, F; Simons, F E R; Sova, M; Spranger, O; Stellato, C; Todo Bom, A; Tomazic, P V; Triggiani, M; Valero, A; Valovirta, E; VandenPlas, O; Valiulis, A; van Eerd, M; Ventura, M T; Wickman, M; Young, I; Zuberbier, T; Zurkuhlen, A; Senn, A

    2017-01-01

    A Good Practice is a practice that works well, produces good results, and is recommended as a model. MACVIA-ARIA Sentinel Network (MASK), the new Allergic Rhinitis and its Impact on Asthma (ARIA) initiative, is an example of a Good Practice focusing on the implementation of multi-sectoral care pathways using emerging technologies with real life data in rhinitis and asthma multi-morbidity. The European Union Joint Action on Chronic Diseases and Promoting Healthy Ageing across the Life Cycle (JA-CHRODIS) has developed a checklist of 28 items for the evaluation of Good Practices. SUNFRAIL (Reference Sites Network for Prevention and Care of Frailty and Chronic Conditions in community dwelling persons of EU Countries), a European Union project, assessed whether MASK is in line with the 28 items of JA-CHRODIS. A short summary was proposed for each item and 18 experts, all members of ARIA and SUNFRAIL from 12 countries, assessed the 28 items using a Survey Monkey-based questionnaire. A visual analogue scale (VAS) from 0 (strongly disagree) to 100 (strongly agree) was used. Agreement equal or over 75% was observed for 14 items (50%). MASK is following the JA-CHRODIS recommendations for the evaluation of Good Practices.

  6. [Qualitative evaluation of employer requirements associated with occupational health and safety as good practice in small-scale enterprises].

    PubMed

    Kuroki, Naomi; Miyashita, Nana; Hino, Yoshiyuki; Kayashima, Kotaro; Fujino, Yoshihisa; Takada, Mikio; Nagata, Tomohisa; Yamataki, Hajime; Sakuragi, Sonoko; Kan, Hirohiko; Morita, Tetsuya; Ito, Akiyoshi; Mori, Koji

    2009-09-01

    The purpose of this study was to identify what motivates employers to promote good occupational health and safety practices in small-scale enterprises. Previous studies have shown that small-scale enterprises generally pay insufficient attention to issues of occupational health and safety. These findings were mainly derived from questionnaire based surveys. Nevertheless, some small-scale enterprises in which employers exercise good leadership do take a progressive approach to occupational health and safety. Although good practices can be identified in small-scale enterprises, it remains unclear what motivates employers in small-scale enterprises to actively implement occupational health and safety practices. We speculated that identifying employer motivations in promoting occupational health would help to spread good practices among small-scale enterprises. Using a qualitative approach based on the KJ methods, we interviewed ten employers who actively promote occupational health and safety in the workplace. The employers were asked to discuss their views of occupational health and safety in their own words. A semi-structured interview format was used, and transcripts were made of the interviews. Each transcript was independently coded by two or more researchers. These transcripts and codes were integrated and then the research group members discussed the heading titles and structural relationships between them according to the KJ method. Qualitative analysis revealed that all the employers expressed a strong interest in a "good company" and "good management". They emphasized four elements of "good management", namely "securing human resources", "trust of business partners", "social responsibility" and "employer's health condition itself", and considered that addressing occupational health and safety was essential to the achievement of these four elements. Consistent with previous findings, the results showed that implementation of occupational health and safety

  7. Business ethics: the materiel/manufacturing perspective.

    PubMed

    Marucheck, A S; Robbins, L B

    1990-08-01

    The discussion of purchasing practices and product integrity, which have ethical implications for materiel/manufacturing management, serves to illustrate how routine decisions can have larger implications for the firm as a whole. Management needs to take a proactive role in confronting ethical issues by (1) demonstrating a corporate commitment to sound ethics in business practices, (2) providing written policies where appropriate to provide a basis for sound ethical conducts, (3) educating various functional areas to understand their responsibility in seeming unrelated ethical problems, (4) delegating authority in ethical issues where such issues are considered in decision making, and (5) fostering interfunctional communication as a means in establishing corporatewide responsibility. The basic philosophical principles of JIT serve as a blueprint for recognizing and managing ethical responsibility. The unexpected by-products of a JIT implementation may be vendor/customer good will and an excellent reputation for the firm.

  8. Preoperative Site Marking: Are We Adhering to Good Surgical Practice?

    PubMed

    Bathla, Sonia; Chadwick, Michael; Nevins, Edward J; Seward, Joanna

    2017-06-29

    Wrong-site surgery is a never event and a serious, preventable patient safety incident. Within the United Kingdom, national guidance has been issued to minimize the risk of such events. The mandate includes preoperative marking of all surgical patients. This study aimed to quantify regional variation in practice within general surgery and opinions of the surgeons, to help guide the formulation and implementation of a regional general surgery preoperative marking protocol. A SurveyMonkey questionnaire was designed and distributed to 120 surgeons within the Mersey region, United Kingdom. This included all surgical trainees in Mersey (47 registrars, 56 core trainees), 15 consultants, and 2 surgical care practitioners. This sought to ascertain their routine practice and how they would choose to mark for 12 index procedures in general surgery, if mandated to do so. A total of 72 responses (60%) were obtained to the SurveyMonkey questionnaire. Only 26 (36.1%) said that they routinely marked all of their patients preoperatively. The operating surgeon marked the patient in 69% of responses, with the remainder delegating this task. Markings were visible after draping in only 55.6% of marked cases. Based on our findings, surgeons may not be adhering to "Good Surgical Practice"; practice is widely variable and surgeons are largely opposed and resistant to marking patients unless laterality is involved. We suggest that all surgeons need to be actively engaged in the design of local marking protocols to gain support, change practice, and reduce errors.

  9. Who Sleeps by Whom Revisited: A Method for Extracting the Moral Goods Implicit in Practice.

    ERIC Educational Resources Information Center

    Schweder, Richard A; And Others

    1995-01-01

    Explores the specific family practice of determining which family members share a bed or sleeping space. Discusses ways of extracting the moral principles implicit in the practice of arranging where family members sleep at night. Examines similarities and differences in the preferred moral goods of two culture regions--rural Hindu India and urban…

  10. [Good practices and techniques for prevention of accidents at work and occupational diseases. New database of Inail].

    PubMed

    Bindi, L; Ossicini, A

    2007-01-01

    The project "The publication of good practices and good techniques for prevention" is one the priorities of nail. This computerized system for the collection of good practices and standards of Good Technology is aimed to health and safety of workers. The basic objective of the database is to provide a valuable tool, usable, dynamic and implemented, in order to facilitate and direct the access to BP and BT it by people responsible for SSL. At the same time constitutes a tool strategically important for enterprises (especially SMEs) in terms of technological innovation and competitiveness, related to the prevention, safety and health of workers. The realization of this project has involved many of the professionals (chemists, engineers, doctors, biologists, geologists, etc.), and everyone gives his intake of qualified professional competence.

  11. Good Education, the Good Teacher, and a Practical Art of Living a Good Life: A Catholic Perspective

    ERIC Educational Resources Information Center

    Hermans, Chris

    2017-01-01

    What is good education? We value education for reasons connected to the good provided by education in society. This good is connected to be the pedagogical aim of education. This article distinguishes five criteria for good education based on the concept of "Bildung". Next, these five criteria are used to develop the idea of the good…

  12. How good are the internal controls in your group practice? Ten questions to contemplate.

    PubMed

    Grant, Barbara J; Foley, Lori A

    2002-01-01

    Internal controls are the methods and procedures used by any business to prevent or detect errors, safeguard assets (especially cash) from being misappropriated, and encourage staff adherence to prescribed managerial policies. Internal controls in a medical practice differ depending on the size and complexity of the practice. The key, however, is that they prevent or detect errors and efforts to circumvent the established policies and procedures of the organization. How good are the internal controls in your group practice? This article identifies ten questions you should use to evaluate your risk of asset misappropriation.

  13. Impacts of Good Practices on Cognitive Development, Learning Orientations, and Graduate Degree Plans during the First Year of College

    ERIC Educational Resources Information Center

    Cruce, Ty M.; Wolniak, Gregory C.; Seifert, Tricia A.; Pascarella, Ernest T.

    2006-01-01

    This study estimated separately the unique effects of three dimensions of good practice and the global effects of a composite measure of good practices on the cognitive development, orientations to learning, and educational aspirations of students during their first year of college. Analyses of longitudinal data from a representative sample of…

  14. Multiple Images, Common Threads. Case Studies of Good Practice in Adult Community Education.

    ERIC Educational Resources Information Center

    Bradshaw, Delia

    This document presents 10 case studies of adult community education programs (ACE) in the state of Victoria, Australia, in the mid 1990s, that were identified as exemplifying the following principles of good practice in ACE: expansiveness, integration, responsiveness, innovation, belonging, explicitness, autonomy, accessibility, synthesis, and…

  15. Developing Countries Vaccine Manufacturers Network: doing good by making high-quality vaccines affordable for all.

    PubMed

    Pagliusi, Sonia; Leite, Luciana C C; Datla, Mahima; Makhoana, Morena; Gao, Yongzhong; Suhardono, Mahendra; Jadhav, Suresh; Harshavardhan, Gutla V J A; Homma, Akira

    2013-04-18

    The Developing Countries Vaccine Manufacturers Network (DCVMN) is a unique model of a public and private international alliance. It assembles governmental and private organizations to work toward a common goal of manufacturing and supplying high-quality vaccines at affordable prices to protect people around the world from known and emerging infectious diseases. Together, this group of manufacturers has decades of experience in manufacturing vaccines, with technologies, know-how, and capacity to produce more than 40 vaccines types. These manufacturers have already contributed more than 30 vaccines in various presentations that have been prequalified by the World Health Organization for use by global immunization programmes. Furthermore, more than 45 vaccines are in the pipeline. Recent areas of focus include vaccines to protect against rotavirus, human papillomavirus (HPV), Japanese encephalitis, meningitis, hepatitis E, poliovirus, influenza, and pertussis, as well as combined pentavalent vaccines for children. The network has a growing number of manufacturers that produce a growing number of products to supply the growing demand for vaccines in developing countries. Copyright © 2013. Published by Elsevier Ltd.

  16. Good Practices in Model‐Informed Drug Discovery and Development: Practice, Application, and Documentation

    PubMed Central

    Burghaus, R; Cosson, V; Cheung, SYA; Chenel, M; DellaPasqua, O; Frey, N; Hamrén, B; Harnisch, L; Ivanow, F; Kerbusch, T; Lippert, J; Milligan, PA; Rohou, S; Staab, A; Steimer, JL; Tornøe, C; Visser, SAG

    2016-01-01

    This document was developed to enable greater consistency in the practice, application, and documentation of Model‐Informed Drug Discovery and Development (MID3) across the pharmaceutical industry. A collection of “good practice” recommendations are assembled here in order to minimize the heterogeneity in both the quality and content of MID3 implementation and documentation. The three major objectives of this white paper are to: i) inform company decision makers how the strategic integration of MID3 can benefit R&D efficiency; ii) provide MID3 analysts with sufficient material to enhance the planning, rigor, and consistency of the application of MID3; and iii) provide regulatory authorities with substrate to develop MID3 related and/or MID3 enabled guidelines. PMID:27069774

  17. Defense programs beryllium good practice guide

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Herr, M.

    1997-07-01

    Within the DOE, it has recently become apparent that some contractor employees who have worked (or are currently working) with and around beryllium have developed chronic beryllium disease (CBD), an occupational granulomatous lung disorder. Respiratory exposure to aerosolized beryllium, in susceptible individuals, causes an immunological reaction that can result in granulomatous scarring of the lung parenchyma, shortness of breath, cough, fatigue, weight loss, and, ultimately, respiratory failure. Beryllium disease was originally identified in the 1940s, largely in the fluorescent light industry. In 1950, the Atomic Energy Commission (AEC) introduced strict exposure standards that generally curtailed both the acute and chronicmore » forms of the disease. Beginning in 1984, with the identification of a CBD case in a DOE contractor worker, there was increased scrutiny of both industrial hygiene practices and individuals in this workforce. To date, over 100 additional cases of beryllium-specific sensitization and/or CBD have been identified. Thus, a disease previously thought to be largely eliminated by the adoption of permissible exposure standards 45 years ago is still a health risk in certain workforces. This good practice guide forms the basis of an acceptable program for controlling workplace exposure to beryllium. It provides (1) Guidance for minimizing worker exposure to beryllium in Defense Programs facilities during all phases of beryllium-related work, including the decontamination and decommissioning (D&D) of facilities. (2) Recommended controls to be applied to the handling of metallic beryllium and beryllium alloys, beryllium oxide, and other beryllium compounds. (3) Recommendations for medical monitoring and surveillance of workers exposed (or potentially exposed) to beryllium, based on the best current understanding of beryllium disease and medical diagnostic tests available. (4) Site-specific safety procedures for all processes of beryllium that is

  18. 40 CFR 1060.301 - Manufacturer testing.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 32 2010-07-01 2010-07-01 false Manufacturer testing. 1060.301 Section 1060.301 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR POLLUTION CONTROLS... Verification Testing § 1060.301 Manufacturer testing. (a) Using good engineering judgment, you must evaluate...

  19. Life‐cycle and cost of goods assessment of fed‐batch and perfusion‐based manufacturing processes for mAbs

    PubMed Central

    Bunnak, Phumthep; Allmendinger, Richard; Ramasamy, Sri V.; Lettieri, Paola

    2016-01-01

    Life‐cycle assessment (LCA) is an environmental assessment tool that quantifies the environmental impact associated with a product or a process (e.g., water consumption, energy requirements, and solid waste generation). While LCA is a standard approach in many commercial industries, its application has not been exploited widely in the bioprocessing sector. To contribute toward the design of more cost‐efficient, robust and environmentally‐friendly manufacturing process for monoclonal antibodies (mAbs), a framework consisting of an LCA and economic analysis combined with a sensitivity analysis of manufacturing process parameters and a production scale‐up study is presented. The efficiency of the framework is demonstrated using a comparative study of the two most commonly used upstream configurations for mAb manufacture, namely fed‐batch (FB) and perfusion‐based processes. Results obtained by the framework are presented using a range of visualization tools, and indicate that a standard perfusion process (with a pooling duration of 4 days) has similar cost of goods than a FB process but a larger environmental footprint because it consumed 35% more water, demanded 17% more energy, and emitted 17% more CO2 than the FB process. Water consumption was the most important impact category, especially when scaling‐up the processes, as energy was required to produce process water and water‐for‐injection, while CO2 was emitted from energy generation. The sensitivity analysis revealed that the perfusion process can be made more environmentally‐friendly than the FB process if the pooling duration is extended to 8 days. © 2016 American Institute of Chemical Engineers Biotechnol. Prog., 32:1324–1335, 2016 PMID:27390260

  20. Encouraging Good Writing Practice in First-Year Psychology Students: An Intervention Using Turnitin

    ERIC Educational Resources Information Center

    Betts, Lucy R.; Bostock, Stephen J.; Elder, Tracey J.; Trueman, Mark

    2012-01-01

    There is growing concern among many regarding plagiarism within student writing. This has promoted investigation into both the factors that predict plagiarism and potential methods of reducing plagiarism. Consequently, we developed and evaluated an intervention to enhance good practice within academic writing through the use of the plagiarism…

  1. Safety practices in Jordanian manufacturing enterprises within industrial estates.

    PubMed

    Khrais, Samir; Al-Araidah, Omar; Aweisi, Assaf Mohammad; Elias, Fadia; Al-Ayyoub, Enas

    2013-01-01

    This paper investigates occupational health and safety practices in manufacturing enterprises within Jordanian industrial estates. Response rates were 21.9%, 58.6% and 70.8% for small, medium and large sized enterprises, respectively. Survey results show that most companies comply with state regulations, provide necessary facilities to enhance safety and provide several measures to limit and control hazards. On the negative side, little attention is given to safety training that might be due to the lack of related regulations and follow-up, financial limitations or lack of awareness on the importance of safety training. In addition, results show that ergonomic hazards, noise and hazardous chemicals are largely present. Accident statistics show that medium enterprises have the highest accident cases per enterprise, and chemical industries reported highest total number of accidents per enterprise. The outcomes of this study establish a base for appropriate safety recommendations to enhance the awareness and commitment of companies to appropriate safety rules.

  2. [How to promote the respect of good infusion practices by meeting health care professionals?].

    PubMed

    Le Reste, C; Fiedler, A; Dubois, S; Dewailly, A; Le Du, I; Cogulet, V

    2016-05-01

    Health care professionals often forget that there are risks associated with infusion therapy even if it is a common care. In order to assess this practice and to draw potential improvement actions, an audit of local gravity-flow intravenous infusion practices was conducted. The audit, based on a grid including 66 items from the medical prescription to the end of the infusion therapy administration, was conducted in the 6 units which use the most gravity-flow intravenous infusion devices. A multidisciplinary working group was created to decide and organize priority corrective measures in order to improve infusion practices and quality of healthcare. The audit enabled to observe 90hours of nurse's practices (96 infusions) and highlighted heterogeneity in infusion, in some cases inappropriate infusion practices and misuse of infusion devices. We found 4 main issues: labelling infusion therapy, training of health care professionals on good practices, support the purchase of infusion pumps and standardize perfusion line. An interactive educational program for nurses (workshops) was organized to enhance the respect of good practices: infusion identification at any time, respect of hygiene rules, flow rate regulation by counting drops, appropriate use of pumps and flow rate regulators. The audit drew up work priorities. The workshops made easier exchanges between professionals and had a warm welcome that's why it is essential to carry on such training. This collaborative approach between pharmacists, nurses, hygienists and biomedical technicians contribute to drug management improvement and promote optimal patient care. Copyright © 2015 Académie Nationale de Pharmacie. Published by Elsevier Masson SAS. All rights reserved.

  3. What Is "Good" Mentoring? Understanding Mentoring Practices of Teacher Induction through Case Studies of Finland and Australia

    ERIC Educational Resources Information Center

    Pennanen, Matti; Bristol, Laurette; Wilkinson, Jane; Heikkinen, Hannu L. T.

    2016-01-01

    Mentoring is a practice widely utilised to support new teachers. However, in locally formed systems, the practice of mentoring is conditioned by traditions and arrangements specific to the site. To understand "good" mentoring, these local arrangements cannot be ignored. In this article, the theory of practice architectures is employed to…

  4. Discrimination and Good Practice Activities in Education: Trends and Developments in the 27 EU Member States

    ERIC Educational Resources Information Center

    Pollak, Alexander

    2008-01-01

    The European Union Agency for Fundamental Rights collects, through its network of observation points, information on discrimination and good practice in the areas of legislation, employment, housing, racist violence, and education. Data on education includes information on: access to education for vulnerable groups, discriminatory practices,…

  5. Smart Manufacturing.

    PubMed

    Davis, Jim; Edgar, Thomas; Graybill, Robert; Korambath, Prakashan; Schott, Brian; Swink, Denise; Wang, Jianwu; Wetzel, Jim

    2015-01-01

    Historic manufacturing enterprises based on vertically optimized companies, practices, market share, and competitiveness are giving way to enterprises that are responsive across an entire value chain to demand dynamic markets and customized product value adds; increased expectations for environmental sustainability, reduced energy usage, and zero incidents; and faster technology and product adoption. Agile innovation and manufacturing combined with radically increased productivity become engines for competitiveness and reinvestment, not simply for decreased cost. A focus on agility, productivity, energy, and environmental sustainability produces opportunities that are far beyond reducing market volatility. Agility directly impacts innovation, time-to-market, and faster, broader exploration of the trade space. These changes, the forces driving them, and new network-based information technologies offering unprecedented insights and analysis are motivating the advent of smart manufacturing and new information technology infrastructure for manufacturing.

  6. 29 CFR 779.108 - Goods produced for commerce.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 29 Labor 3 2011-07-01 2011-07-01 false Goods produced for commerce. 779.108 Section 779.108 Labor... Coverage Employees Engaged in Commerce Or in the Production of Goods for Commerce § 779.108 Goods produced for commerce. Goods are “produced for commerce” if they are “produced, manufactured, mined, handled or...

  7. 29 CFR 779.108 - Goods produced for commerce.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 29 Labor 3 2012-07-01 2012-07-01 false Goods produced for commerce. 779.108 Section 779.108 Labor... Coverage Employees Engaged in Commerce Or in the Production of Goods for Commerce § 779.108 Goods produced for commerce. Goods are “produced for commerce” if they are “produced, manufactured, mined, handled or...

  8. 29 CFR 779.108 - Goods produced for commerce.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 29 Labor 3 2014-07-01 2014-07-01 false Goods produced for commerce. 779.108 Section 779.108 Labor... Coverage Employees Engaged in Commerce Or in the Production of Goods for Commerce § 779.108 Goods produced for commerce. Goods are “produced for commerce” if they are “produced, manufactured, mined, handled or...

  9. 29 CFR 779.108 - Goods produced for commerce.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 29 Labor 3 2013-07-01 2013-07-01 false Goods produced for commerce. 779.108 Section 779.108 Labor... Coverage Employees Engaged in Commerce Or in the Production of Goods for Commerce § 779.108 Goods produced for commerce. Goods are “produced for commerce” if they are “produced, manufactured, mined, handled or...

  10. 29 CFR 779.108 - Goods produced for commerce.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 29 Labor 3 2010-07-01 2010-07-01 false Goods produced for commerce. 779.108 Section 779.108 Labor... Coverage Employees Engaged in Commerce Or in the Production of Goods for Commerce § 779.108 Goods produced for commerce. Goods are “produced for commerce” if they are “produced, manufactured, mined, handled or...

  11. Performance-based risk-sharing arrangements-good practices for design, implementation, and evaluation: report of the ISPOR good practices for performance-based risk-sharing arrangements task force.

    PubMed

    Garrison, Louis P; Towse, Adrian; Briggs, Andrew; de Pouvourville, Gerard; Grueger, Jens; Mohr, Penny E; Severens, J L Hans; Siviero, Paolo; Sleeper, Miguel

    2013-01-01

    There is a significant and growing interest among both payers and producers of medical products for agreements that involve a "pay-for-performance" or "risk-sharing" element. These payment schemes-called "performance-based risk-sharing arrangements" (PBRSAs)-involve a plan by which the performance of the product is tracked in a defined patient population over a specified period of time and the amount or level of reimbursement is based on the health and cost outcomes achieved. There has always been considerable uncertainty at product launch about the ultimate real-world clinical and economic performance of new products, but this appears to have increased in recent years. PBRSAs represent one mechanism for reducing this uncertainty through greater investment in evidence collection while a technology is used within a health care system. The objective of this Task Force report was to set out the standards that should be applied to "good practices"-both research and operational-in the use of a PBRSA, encompassing questions around the desirability, design, implementation, and evaluation of such an arrangement. This report provides practical recommendations for the development and application of state-of-the-art methods to be used when considering, using, or reviewing PBRSAs. Key findings and recommendations include the following. Additional evidence collection is costly, and there are numerous barriers to establishing viable and cost-effective PBRSAs: negotiation, monitoring, and evaluation costs can be substantial. For good research practice in PBRSAs, it is critical to match the appropriate study and research design to the uncertainties being addressed. Good governance processes are also essential. The information generated as part of PBRSAs has public good aspects, bringing ethical and professional obligations, which need to be considered from a policy perspective. The societal desirability of a particular PBRSA is fundamentally an issue as to whether the cost of

  12. VET Retention in Remote Aboriginal and Torres Strait Islander Communities. Good Practice Guide

    ERIC Educational Resources Information Center

    National Centre for Vocational Education Research (NCVER), 2017

    2017-01-01

    This good practice guide is based on the research project "Enhancing training advantage for remote Aboriginal and Torres Strait Islander learners" by John Guenther et al. on behalf of Ninti One Limited. The project examines five unique and successful vocational education and training (VET) programs in remote areas and identifies how…

  13. Social and Occupational Integration of Disadvantaged People. Leonardo da Vinci Good Practices Series.

    ERIC Educational Resources Information Center

    Commission of the European Communities, Brussels (Belgium). Directorate-General for Education and Culture.

    This document profiles nine European programs that exemplify good practice in social and occupational integration of disadvantaged people. The programs profiled are as follows: (1) Restaurant Venezia (a CD-ROM program to improve the reading and writing skills of young people in Luxembourg who have learning difficulties); (2) an integrated…

  14. Evaluation of the Implementation of Good Handling Practices in Food and Beverage Areas of Hotels.

    PubMed

    Serafim, A L; Hecktheuer, L H R; Stangarlin-Fiori, L; Medeiros, L B; Martello, L; Machado, C E

    2015-11-01

    Because of the major international-level events that have recently been held in Brazil, concerns about the sensory and hygienic-sanitary conditions of food have increased. The objective of this study was to evaluate the implementation of good handling practices in food and beverage areas of hotels, with and without outsourced professional intervention. We evaluated 19 food and beverage areas in hotels in Porto Alegre, Rio do Sul, Brazil, using a checklist that was developed by a municipal surveillance team based on existing laws for good handling practices. The evaluation was done by a skilled professional in the food safety area on two occasions, at the beginning of the study (January to May 2013) and at the end (July to November 2014), and the establishments were classified as good, regular, or poor. After the baseline evaluation, an action plan listing the noncompliance found at each location was given to those responsible for the establishments, and a period of 1 year 6 months was stipulated for improvements to be made. In the repeat evaluation, those responsible for the establishments were asked whether they had hired an outsourced professional to assist them in the improvements. The hotels showed improvement during the repeat evaluation, but a significant increase in the percentage of overall adequacy was seen only in the food and beverages areas of the 12 hotels that used the intervention of an outsourced professional. The better percentage of adequacy in establishments with outsourced professional intervention underlines the importance of an external and impartial view of routine activities in the implementation of good handling practices.

  15. The constraints of good governance practice in national solid waste management policy (NSWMP) implementation: A case study of Malaysia

    NASA Astrophysics Data System (ADS)

    Wee, Seow Ta; Abas, Muhamad Azahar; Chen, Goh Kai; Mohamed, Sulzakimin

    2017-10-01

    Nowadays, international donors have emphasised on the adoption of good governance practices in solid waste management which include policy implementation. In Malaysia, the National Solid Waste Management Policy (NSWMP) was introduced as the main guideline for its solid waste management and the Malaysian government has adopted good governance practice in the NSMWP implementation. However, the good governance practices implemented by the Malaysian government encountered several challenges. This study was conducted to explore the good governance constraints experienced by stakeholders in the NSWMP implementation. An exploratory research approach is applied in this study through in-depth interviews with several government agencies and concessionaires that involved in the NSWMP implementation in Malaysia. A total of six respondents took part in this study. The findings revealed three main good governance constraints in the NSWMP implementation, namely inadequate fund, poor staff's competency, and ambiguity of policy implementation system. Moreover, this study also disclosed that the main constraint influenced the other constraints. Hence, it is crucial to identify the main constraint in order to minimise its impact on the other constraints.

  16. Study of flow stress and spall strength of additively manufactured Ti-6-4 alloy

    NASA Astrophysics Data System (ADS)

    Cohen, Amitay; Paris, Vitaly; Yosef-Hai, Arnon; Gudinetsky, Eli; Tiferet, Eitan

    2017-06-01

    The use of additive manufacturing (AM) by Electron Beam Melting (EBM) or Selective Laser Melting (SLM) has extensively grown in the past few years. A major goal in AM is to manufacture materials with mechanical properties at least as good as traditionally manufactured materials. In this work we present results of planar impact tests and Split Hopkinson Pressure Bar tests (SHPB) on Ti-6-4 manufactured by EBM and SLM processes. Results of planar impact tests on SLM samples display slightly higher spall strength compared to EBM while the stress at Hugoniot elastic limit (HEL) is practically the same. Stress strain curves based on SHPB measurements at two different strain rates present similar plastic flow stresses for SLM and EBM processed Ti-6-4 alloy, while the flow stress is about 20% higher than reported for commercial reference material. The strain to failure of both materials shows considerable strain rate sensitivity. The results of post-mortem analysis of spall fracture will also be presented.

  17. Assurance of Medical Device Quality with Quality Management System: An Analysis of Good Manufacturing Practice Implementation in Taiwan

    PubMed Central

    Tu, Pei-Weng; Wu, Shiow-Ing

    2015-01-01

    The implementation of an effective quality management system has always been considered a principal method for a manufacturer to maintain and improve its product and service quality. Globally many regulatory authorities incorporate quality management system as one of the mandatory requirements for the regulatory control of high-risk medical devices. The present study aims to analyze the GMP enforcement experience in Taiwan between 1998 and 2013. It describes the regulatory implementation of medical device GMP requirement and initiatives taken to assist small and medium-sized enterprises in compliance with the regulatory requirement. Based on statistical data collected by the competent authority and industry research institutes, the present paper reports the growth of Taiwan local medical device industry after the enforcement of GMP regulation. Transition in the production, technologies, and number of employees of Taiwan medical device industry between 1998 and 2013 provides the competent authorities around the world with an empirical foundation for further policy development. PMID:26075255

  18. Assurance of medical device quality with quality management system: an analysis of good manufacturing practice implementation in Taiwan.

    PubMed

    Li, Tzu-Wei; Tu, Pei-Weng; Liu, Li-Ling; Wu, Shiow-Ing

    2015-01-01

    The implementation of an effective quality management system has always been considered a principal method for a manufacturer to maintain and improve its product and service quality. Globally many regulatory authorities incorporate quality management system as one of the mandatory requirements for the regulatory control of high-risk medical devices. The present study aims to analyze the GMP enforcement experience in Taiwan between 1998 and 2013. It describes the regulatory implementation of medical device GMP requirement and initiatives taken to assist small and medium-sized enterprises in compliance with the regulatory requirement. Based on statistical data collected by the competent authority and industry research institutes, the present paper reports the growth of Taiwan local medical device industry after the enforcement of GMP regulation. Transition in the production, technologies, and number of employees of Taiwan medical device industry between 1998 and 2013 provides the competent authorities around the world with an empirical foundation for further policy development.

  19. Guide to good practices for operations and administration updates through required reading

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    NONE

    1998-12-01

    This Guide to Good Practices is written to enhance understanding of, and provide direction for, Required Reading, Chapter XIV of Department of Energy (DOE) Order 5480.19, Conduct of Operations Requirements for DOE Facilities. The practices in this guide should be considered when planning or reviewing programs for updating personnel with operations and administration information through required reading. Contractors are advised to adopt procedures that meet the intent of DOE Order 5480.19. Required Reading is an element of an effective Conduct of Operations program. The complexity and array of activities performed in DOE facilities dictate the necessity for a coordinated requiredmore » reading program to promote safe and efficient operations.« less

  20. Twenty-Two Good Educational Practices.

    ERIC Educational Resources Information Center

    Mark, Jorie Lester

    1989-01-01

    Twenty-two educational practices are drawn from nine settings: K-12, vocational and continuing education, proprietary schools, military training, corporate training, union-sponsored programs, second-chance training, job training, and adult education. They are categorized as process-type practices, techniques, and physical teaching props. (SK)

  1. Jobs in Manufacturing. Job Family Series.

    ERIC Educational Resources Information Center

    Science Research Associates, Inc., Chicago, IL.

    The instructional booklet explores various occupations in the occupational cluster of manufacturing. In the first chapter, the student is briefly introduced to the occupational cluster concept and to the general area of manufacturing. Chapter 2 describes jobs involved in the production of materials and processing of goods. Chapter 3 discusses…

  2. Exposure monitoring of graphene nanoplatelets manufacturing workplaces.

    PubMed

    Lee, Ji Hyun; Han, Jong Hun; Kim, Jae Hyun; Kim, Boowook; Bello, Dhimiter; Kim, Jin Kwon; Lee, Gun Ho; Sohn, Eun Kyung; Lee, Kyungmin; Ahn, Kangho; Faustman, Elaine M; Yu, Il Je

    2016-01-01

    at Workplace A. The TEM observation of the samples obtained from Workplaces A and B showed graphene-like structures and aggregated/agglomerated carbon structures. Taken together, the current findings on common scenarios (exfoliation, CVD growth, and transfer), while not inclusive of all graphene manufacturing processes, indicate very minimal graphene or particle exposure at facilities manufacturing graphenes with good manufacturing practices.

  3. Life-cycle and cost of goods assessment of fed-batch and perfusion-based manufacturing processes for mAbs.

    PubMed

    Bunnak, Phumthep; Allmendinger, Richard; Ramasamy, Sri V; Lettieri, Paola; Titchener-Hooker, Nigel J

    2016-09-01

    Life-cycle assessment (LCA) is an environmental assessment tool that quantifies the environmental impact associated with a product or a process (e.g., water consumption, energy requirements, and solid waste generation). While LCA is a standard approach in many commercial industries, its application has not been exploited widely in the bioprocessing sector. To contribute toward the design of more cost-efficient, robust and environmentally-friendly manufacturing process for monoclonal antibodies (mAbs), a framework consisting of an LCA and economic analysis combined with a sensitivity analysis of manufacturing process parameters and a production scale-up study is presented. The efficiency of the framework is demonstrated using a comparative study of the two most commonly used upstream configurations for mAb manufacture, namely fed-batch (FB) and perfusion-based processes. Results obtained by the framework are presented using a range of visualization tools, and indicate that a standard perfusion process (with a pooling duration of 4 days) has similar cost of goods than a FB process but a larger environmental footprint because it consumed 35% more water, demanded 17% more energy, and emitted 17% more CO 2 than the FB process. Water consumption was the most important impact category, especially when scaling-up the processes, as energy was required to produce process water and water-for-injection, while CO 2 was emitted from energy generation. The sensitivity analysis revealed that the perfusion process can be made more environmentally-friendly than the FB process if the pooling duration is extended to 8 days. © 2016 American Institute of Chemical Engineers Biotechnol. Prog., 32:1324-1335, 2016. © 2016 The Authors Biotechnology Progress published by Wiley Periodicals, Inc. on behalf of American Institute of Chemical Engineers.

  4. Characteristics of good quality pharmaceutical services common to community pharmacies and dispensing general practices.

    PubMed

    Grey, Elisabeth; Harris, Michael; Rodham, Karen; Weiss, Marjorie C

    2016-10-01

    In the United Kingdom, pharmaceutical services can be delivered by both community pharmacies (CPs) and dispensing doctor practices (DPs). Both must adhere to minimum standards set out in NHS regulations; however, no common framework exists to guide quality improvement. Previous phases of this research had developed a set of characteristics indicative of good pharmaceutical service provision. To ask key stakeholders to confirm, and rank the importance of, a set of characteristics of good pharmaceutical service provision. A two-round Delphi-type survey was conducted in south-west England and was sent to participants representing three stakeholder groups: DPs, CPs and patients/lay members. Participants were asked to confirm, and rank, the importance of these characteristics as representing good quality pharmaceutical services. Thirty people were sent the first round survey; 22 participants completed both rounds. Median ratings for the 23 characteristics showed that all were seen to represent important aspects of pharmaceutical service provision. Participants' comments highlighted potential problems with the practicality of the characteristics. Characteristics relating to patient safety were deemed to be the most important and those relating to public health the least important. A set of 23 characteristics for providing good pharmaceutical services in CPs and DPs was developed and attained approval from a sample of stakeholders. With further testing and wider discussion, it is hoped that the characteristics will form the basis of a quality improvement tool for CPs and DPs. © 2016 Royal Pharmaceutical Society.

  5. Self-assessed competency at working with a medical interpreter is not associated with knowledge of good practice.

    PubMed

    Hudelson, Patricia; Perneger, Thomas; Kolly, Véronique; Perron, Noëlle Junod

    2012-01-01

    Specific knowledge and skills are needed to work effectively with an interpreter, but most doctors have received limited training. Self-assessed competency may not accurately identify training needs. The purpose of this study is to explore the association between self-assessed competency at working with an interpreter and the ability to identify elements of good practice, using a written vignette. A mailed questionnaire was sent to 619 doctors and medical students in Geneva, Switzerland. 58.6% of respondents considered themselves to be highly competent at working with a professional interpreter, but 22% failed to mention even one element of good practice in response to the vignette, and only 39% could name more than one. There was no association between self-rated competency and number of elements mentioned. Training efforts should challenge the assumption that working with an interpreter is intuitive. Evaluation of clinicians' ability to work with an interpreter should not be limited to self-ratings. In the context of large-scale surveys, written vignettes may provide a simple method for identifying knowledge of good practice and topics requiring further training.

  6. Good Practice Guide: Bringing a Social Capital Approach into the Teaching of Adult Literacy and Numeracy

    ERIC Educational Resources Information Center

    National Centre for Vocational Education Research (NCVER), 2010

    2010-01-01

    This good practice guide is based on research that looked at how to teach adult literacy and numeracy using a social capital approach. The guide suggests ways vocational education and training (VET) practitioners can adopt a social capital approach to their teaching practice. A social capital approach refers to the process in which networks are…

  7. Simulation of changes on the psychosocial risk in the nursing personnel after implementing the policy of good practices on the risk treatment.

    PubMed

    Bolívar Murcia, María Paula; Cruz González, Joan Paola; Rodríguez Bello, Luz Angélica

    2018-02-01

    Evaluate the change over time of psychosocial risk management for the nursing personnel of an intermediate complexity clinic of Bogota (Colombia). Descriptive and correlational research performed under the approach of risk management (identification, analysis, assessment and treatment). The psychosocial risk of the nursing personnel was studied through 10-year system dynamics models (with and without the implementation of the policy of good practices on the risk treatment) in two scenarios: when the nursing personnel works shifts of 6 hours (morning or afternoon) and when they work over 12 hours (double shift or night shift). When implementing a policy of good practices on the risk treatment, the double shift scenario shows an improvement among 25% to 88% in the variables of: health, labor motivation, burnout, service level and productivity; as well as in the variables of the organization associated to number of patients, nursing personnel and profit. Likewise, the single shift scenario with good practices improves in all the above-mentioned variables and generates stability on the variables of absenteeism and resignations. The best scenario is the single shift scenario with the application of good practices of risk treatment in comparison with the double shift scenario with good practices, which allows concluding that the good practices have a positive effect on the variables of nursing personnel and on those associated to the organization. Copyright© by the Universidad de Antioquia.

  8. Are general practice characteristics predictors of good glycaemic control in patients with diabetes? A cross-sectional study.

    PubMed

    Esterman, Adrian J; Fountaine, Tim; McDermott, Robyn

    2016-01-18

    To determine whether certain characteristics of general practices are associated with good glycaemic control in patients with diabetes and with completing an annual cycle of care (ACC). Our cross-sectional analysis used baseline data from the Australian Diabetes Care Project conducted between 2011 and 2014. Practice characteristics were self-reported. Characteristics of the patients that were assessed included glycaemic control (HbA1c level ≤ 53 mmol/mol), age, sex, duration of diabetes, socio-economic disadvantage (SEIFA) score, the complexity of the patient's condition, and whether the patient had completed an ACC for diabetes in the past 18 months. Clustered logistic regression was used to establish predictors of glycaemic control and a completed ACC. Data were available from 147 general practices and 5455 patients with established type 1 or type 2 diabetes in three Australian states. After adjustment for other patient characteristics, only the patient completing an ACC was statistically significant as a predictor of glycaemic control (P = 0.011). In a multivariate model, the practice having a chronic disease-focused practice nurse (P = 0.036) and running educational events for patients with diabetes (P = 0.004) were statistically significant predictors of the patient having complete an ACC. Patient characteristics are moderately good predictors of whether the patient is in glycaemic control, whereas practice characteristics appear to predict only the likelihood of patients completing an ACC. The ACC is an established indicator of good diabetes management. This is the first study to report a positive association between having completed an ACC and the patient being in glycaemic control.

  9. Good practices and health policy analysis in European sports stadia: results from the 'Healthy Stadia' project.

    PubMed

    Drygas, Wojciech; Ruszkowska, Joanna; Philpott, Matthew; Björkström, Olav; Parker, Mike; Ireland, Robin; Roncarolo, Federico; Tenconi, Maria

    2013-06-01

    Sport plays an important role within society and sports stadia provide significant settings for public health strategies. In addition to being places of mass gathering, stadia are often located in less affluent areas and are traditionally attended by 'harder to reach' communities. Unfortunately sports stadia and the clubs they host are rarely perceived as places that promote healthy lifestyles. Fast food, alcohol and tobacco are commonly advertized, served and consumed during sports games giving the spectators and TV fans contradictory messages concerning healthy choices. As part of a wider programme of work part-funded by the European Union, a study was therefore designed to explore current 'good practice' relating to positive health interventions in sports stadia across a number of European countries. Using a specially designed questionnaire, information about health policies and good practices relating to food offerings in stadia, physical activity promotion among local communities, tobacco policy, positive mental health initiatives, environmental sustainability practices and social responsibility policies were collected in 10 European countries (England and Northern Ireland, Finland, Georgia, Greece, Ireland, Italy, Latvia, Poland, Spain and Sweden) involving 88 stadia. The audit results show that stadia health policies differ considerably between specific countries and sports. Based on the literature analysed, the examples of good practices collected through the study, and the subsequent instigation of a European Healthy Stadia Network, it shows that there is considerable potential for stadia to become health promoting settings.

  10. 40 CFR 94.221 - Application of good engineering judgment.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 40 Protection of Environment 21 2012-07-01 2012-07-01 false Application of good engineering... § 94.221 Application of good engineering judgment. (a) The manufacturer shall exercise good engineering... the Administrator) a written description of the engineering judgment in question. (c) The...

  11. 40 CFR 94.221 - Application of good engineering judgment.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 20 2010-07-01 2010-07-01 false Application of good engineering... § 94.221 Application of good engineering judgment. (a) The manufacturer shall exercise good engineering... the Administrator) a written description of the engineering judgment in question. (c) The...

  12. 40 CFR 94.221 - Application of good engineering judgment.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 40 Protection of Environment 21 2013-07-01 2013-07-01 false Application of good engineering... § 94.221 Application of good engineering judgment. (a) The manufacturer shall exercise good engineering... the Administrator) a written description of the engineering judgment in question. (c) The...

  13. 40 CFR 94.221 - Application of good engineering judgment.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 40 Protection of Environment 20 2014-07-01 2013-07-01 true Application of good engineering... § 94.221 Application of good engineering judgment. (a) The manufacturer shall exercise good engineering... the Administrator) a written description of the engineering judgment in question. (c) The...

  14. 40 CFR 94.221 - Application of good engineering judgment.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 40 Protection of Environment 20 2011-07-01 2011-07-01 false Application of good engineering... § 94.221 Application of good engineering judgment. (a) The manufacturer shall exercise good engineering... the Administrator) a written description of the engineering judgment in question. (c) The...

  15. Validation of good agricultural practices (GAP) on Minnesota vegetable farms.

    PubMed

    Hamilton, Karin E; Umber, Jamie; Hultberg, Annalisa; Tong, Cindy; Schermann, Michele; Diez-Gonzalez, Francisco; Bender, Jeff B

    2015-02-01

    The United States Food and Drug Administration and the Department of Agriculture jointly published the "Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables," which is used as a basis for Good Agricultural Practices (GAP) audits. To understand barriers to incorporation of GAP by Minnesota vegetable farmers, a mail survey completed in 2008 was validated with visits to a subset of the farms. This was done to determine the extent to which actual practices matched perceived practices. Two hundred forty-six producers completed the mail survey, and 27 participated in the on-farm survey. Over 75% of the on-farm survey respondents produced vegetables on 10 acres or less and had 10 or fewer employees. Of 14 questions, excellent agreement between on-farm interviews and mail survey responses was observed on two questions, four questions had poor or slight agreement, and eight questions had no agreement. Ninety-two percent of respondents by mail said "they took measures to keep animals and pests out of packing and storage buildings." However, with the on-site visit only 45% met this requirement. Similarly, 81% of respondents by mail said "measures were taken to reduce the risk of wild and/or domestic animals entering into fruit and vegetable growing areas." With direct observation, 70% of farms actually had taken measures to keep animals out of the growing areas. Additional, on-farm assessments were done regarding employee hygiene, training, presence of animals, water sources, and composting practices. This validation study demonstrated the challenge of creating nonleading and concise questions that are not open to broad interpretation from the respondents. If mail surveys are used to assess GAP, they should include open-ended questions and ranking systems to better assess farm practices. To provide the most accurate survey data for educational purposes or GAP audits, on-farm visits are recommended.

  16. Circular economy practices among Chinese manufacturers varying in environmental-oriented supply chain cooperation and the performance implications.

    PubMed

    Zhu, Qinghua; Geng, Yong; Lai, Kee-hung

    2010-06-01

    The rapidly growing industrial activities in emerging economies such as China have been causing resource depletion and pollution problems. This reality requires China to adopt an integrated management approach to resolve the conflict between industrial development and environmental protection, and the concept of circular economy (CE) serves this purpose. In this paper, we examine if different types of manufacturing enterprises on environmental-oriented supply chain cooperation (ESCC) exist. We also determine if the Chinese manufacturer types varying in ESCC differ in their implementation of the CE practices towards achieving the CE-targeted goals on improving both environmental and economic performance. Our cluster analytic results with multivariate analysis of variance (MANOVA) among the four identified types of Chinese manufacturers varying in environmental-oriented supply chain cooperation highlight the importance to intensify the cooperation with upstream and downstream supply chain partners for a CE initiative to succeed. (c) 2010 Elsevier Ltd. All rights reserved.

  17. Controversy over drill pipe, tubular goods heats up as US increases import duties

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    NONE

    U.S.makers of oil country tubular goods (OCTG) and line pipe accused foreign manufacturers of dumping goods in the country, and the U.S. Department of Commerce International Trade Administration (ITA) agreed with them. The ITA then slapped duties on foreign manufacturers. The manufacturers appealed the decision and the U.S. International Trade Commission upheld the ITA ruling and reinforced it by saying the actions by foreign manufacturers hurt U.S. OCTG makers. Many groups oppose the tariff. This paper describes this controversy and describes some of the impacts on various industries.

  18. Accommodating Learning Styles: Relevance and Good Practice in Vocational Education and Training--Supporting Documents

    ERIC Educational Resources Information Center

    Smith, Peter; Dalton, Jennifer; Henry, John

    2005-01-01

    This document was produced by the author(s) based on their research for the Australian report, "Accommodating Learning Styles: Relevance and Good Practice in Vocational Education and Training," and contains three parts. Part 1, Research Methodology and Findings (Peter Smith and Jennifer Dalton), contains: (1) Research Questions; (2)…

  19. Development of good modelling practice for phsiologically based pharmacokinetic models for use in risk assessment: The first steps

    EPA Science Inventory

    The increasing use of tissue dosimetry estimated using pharmacokinetic models in chemical risk assessments in multiple countries necessitates the need to develop internationally recognized good modelling practices. These practices would facilitate sharing of models and model eva...

  20. Linking human capital and enterprise sustainability in Indonesian medium-sized food manufacturing enterprises: the role of informal knowledge sharing practice

    NASA Astrophysics Data System (ADS)

    Sunardi, O.

    2017-12-01

    Medium-sized food manufacturing enterprises in Indonesia are significant in a number of contexts, in terms of their part to the national production (GDP) and their establishment to the employment. In term of their role to national production, manufacturing sector contributes the highest GDP by 85%. In this sector, food manufacturing subsector contributes the highest GDP. Nevertheless, they faced the same common problems: quality of human capital and sustainability issues. Previous government supplementary programs have been established to expand the human capital capability amongst medium enterprises. Adequate amount of fund has been apportioned to develop human capital, though, the medium enterprises sustainability is still in question. This study proposes and examines the human capital role from informal knowledge sharing perspective. By conducting qualitative approach through interviews to four informants in Indonesian medium-sized food manufacturing enterprises, a set of hypotheses is derived from this study for future quantitative study. This study indicates that human capital traits (diverse education background, employee skills, and employee experience) could leverage the practice of informal knowledge sharing. Constructs such as mutual trust and reciprocal intention could play as mediating variables, and cultural interpretation perspective could act as moderating factor to informal knowledge sharing effectiveness. In final, informal knowledge sharing is indicated to play as moderating variable for human capital policy and practice to support enterprise sustainability.

  1. Practical aspects of modern interferometry for optical manufacturing quality control: Part 2

    NASA Astrophysics Data System (ADS)

    Smythe, Robert

    2012-07-01

    Modern phase shifting interferometers enable the manufacture of optical systems that drive the global economy. Semiconductor chips, solid-state cameras, cell phone cameras, infrared imaging systems, space based satellite imaging and DVD and Blu-Ray disks are all enabled by phase shifting interferometers. Theoretical treatments of data analysis and instrument design advance the technology but often are not helpful towards the practical use of interferometers. An understanding of the parameters that drive system performance is critical to produce useful results. Any interferometer will produce a data map and results; this paper, in three parts, reviews some of the key issues to minimize error sources in that data and provide a valid measurement.

  2. Practical aspects of modern interferometry for optical manufacturing quality control, Part 3

    NASA Astrophysics Data System (ADS)

    Smythe, Robert A.

    2012-09-01

    Modern phase shifting interferometers enable the manufacture of optical systems that drive the global economy. Semiconductor chips, solid-state cameras, cell phone cameras, infrared imaging systems, space-based satellite imaging, and DVD and Blu-Ray disks are all enabled by phase-shifting interferometers. Theoretical treatments of data analysis and instrument design advance the technology but often are not helpful toward the practical use of interferometers. An understanding of the parameters that drive the system performance is critical to produce useful results. Any interferometer will produce a data map and results; this paper, in three parts, reviews some of the key issues to minimize error sources in that data and provide a valid measurement.

  3. Scaleable processes for the manufacture of therapeutic quantities of plasmid DNA.

    PubMed

    Shamlou, Parviz Ayazi

    2003-06-01

    The need for scaleable processes to manufacture therapeutic plasmid DNA (pDNA) is easy to overlook when attention is focused primarily on vector design and establishment of early clinical results. pDNA is a large molecule and has properties that are similar to those of the contaminating chromosomal DNA. These, combined with the low initial concentration of plasmids in the host cell, provide unique process challenges that require significant upfront design to establish robust manufacturing processes that can also comply with current Good Manufacturing Practice ('cGMP') and produce milligram-to-kilogram quantities of pDNA product. This review describes promising scaleable processes that are currently being assessed for production of therapeutic supercoiled pDNA. Fermentation strategies for improving supercoiled plasmid yield and reducing contaminant concentrations are reviewed, and downstream processes are assessed for their ability to efficiently remove cellular contaminants, separate the supercoiled form of the pDNA from its open circular and linear forms, and prepare the purified drug substance for formulation. Current strategies are presented for developing stable delivery systems, and approaches to quality assurance and quality control are discussed.

  4. Singing in Primary Schools: Case Studies of Good Practice in Whole Class Vocal Tuition

    ERIC Educational Resources Information Center

    Lamont, Alexandra; Daubney, Alison; Spruce, Gary

    2012-01-01

    Within the context of British initiatives in music education such as the Wider Opportunities programme in England and the recommendations of the Music Manifesto emphasising the importance of singing in primary schools, the current paper explores examples of good practice in whole-class vocal tuition. The research included seven different primary…

  5. Long-term effects of good handling practices during the pre-weaning period of crossbred dairy heifer calves.

    PubMed

    Silva, Luciana Pontes; Sant'Anna, Aline Cristina; Silva, Lívia Carolina Magalhães; Paranhos da Costa, Mateus José Rodrigues

    2017-01-01

    The aim of this study was to determine whether applying good practices of handling during the pre-weaning period have long-term effects on behavioral and physiological indicators, health status, and average daily gain (ADG) of crossbred Bos taurus × Bos indicus heifer calves. During the pre-weaning period, 98 crossbred of Holstein × Gir heifer calves were allotted into three treatments: (1) good practices of handling + brushing (GPB; n = 25), (2) good practices of handling (GP; n = 25), and (3) control (n = 48). Every 2 months, four evaluation periods (EV 1 to EV 4 ) were conducted to record data. Behavioral indicators comprised time to drive (TD), flight speed (FS), flight distance (FD), and composite reactivity score (CRS). Physiological indicators of acute stress during handling comprised respiratory and heart rates. Health status comprised data regarding occurrence of most common diseases (i.e., pneumonia and anaplasmosis). Collected data were analyzed by using a linear mixed model for repeated measures, Tukey's test, and chi-squared procedures. Treatment influenced (P < 0.05) TD, FS, and FD but not CRS (P = 0.78). From EV 1 to EV 3 , the control calves had the lowest TD. The GPB group had lower FS than the control but did not differ from GP. The GPB group had lower FD means than the other two groups in EV 2 , EV 3 , and EV 4 . No differences (P > 0.05) due to treatment were observed on heart and respiratory rates, ADG, or occurrence of pneumonia and anaplasmosis. It was concluded that adoption of good practices of handling during pre-weaning period may lead to long-term positive effects.

  6. Control systems engineering in continuous pharmaceutical manufacturing. May 20-21, 2014 Continuous Manufacturing Symposium.

    PubMed

    Myerson, Allan S; Krumme, Markus; Nasr, Moheb; Thomas, Hayden; Braatz, Richard D

    2015-03-01

    drug manufacturing that are easily transportable to industry. Industry can facilitate the move to continuous manufacturing by working with universities on the conception of new continuous pharmaceutical manufacturing process unit operations that have the potential to make major improvements in product quality, controllability, or reduced capital and/or operating costs. Regulatory bodies should ensure that: (1) regulations and regulatory practices promote, and do not derail, the development and implementation of continuous manufacturing and control systems engineering approaches; (2) the individuals who approve specific regulatory filings are sufficiently trained to make good decisions regarding control systems approaches; (3) provide regulatory clarity and eliminate/reduce regulatory risks; (4) financially support the development of high-quality training materials for use of undergraduate students, graduate students, industrial employees, and regulatory staff; (5) enhance the training of their own technical staff by financially supporting joint research projects with universities in the development of continuous pharmaceutical manufacturing processes and the associated control systems engineering theory, numerical algorithms, and software; and (6) strongly encourage the federal agencies that support research to fund these research areas. © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association.

  7. The Health Behavior Checklist: Factor structure in community samples and validity of a revised good health practices scale.

    PubMed

    Hampson, Sarah E; Edmonds, Grant W; Goldberg, Lewis R

    2017-01-01

    This study examined the factor structure and predictive validity of the commonly used multidimensional Health Behavior Checklist. A three-factor structure was found in two community samples that included men and women. The new 16-item Good Health Practices scale and the original Wellness Maintenance scale were the only Health Behavior Checklist scales to be related to cardiovascular and metabolic risk factors. While the other Health Behavior Checklist scales require further validation, the Good Health Practices scale could be used where more objective or longer measures are not feasible.

  8. Development and validation of a multiplex quantitative polymerase chain reaction assay for the detection of Mollicutes impurities in human cells, cultured under good manufacturing practice conditions, and following European Pharmacopoeia requirements and the International Conference on Harmonization guidelines.

    PubMed

    Vanni, Irene; Ugolotti, Elisabetta; Raso, Alessandro; Di Marco, Eddi; Melioli, Giovanni; Biassoni, Roberto

    2012-07-01

    The clinical applications of in vitro manipulated cultured cells and their precursors are often made use of in therapeutic trials. However, tissue cultures can be easily contaminated by the ubiquitous Mollicutes micro-organisms, which can cause various and severe alterations in cellular function. Thus methods able to detect and trace Mollicutes impurities contaminating cell cultures are required before starting any attempt to grow cells under good manufacturing practice (GMP) conditions. We developed a multiplex quantitative polymerase chain reaction (qPCR) assay specific for the 16S-23S rRNA intergenic spacer regions, for the Tuf and P1 cytoadhesin genes, able to detect contaminant Mollicutes species in a single tube reaction. The system was validated by analyzing different cell lines and the positive samples were confirmed by 16S and P1 cytoadhesin gene dideoxy sequencing. Our multiplex qPCR detection system was able to reach a sensitivity, specificity and robustness comparable with the culture and the indicator cell culture method, as required by the European Pharmacopoeia guidelines. We have developed a multiplex qPCR method, validated following International Conference on Harmonization (ICH) guidelines, as a qualitative limit test for impurities, assessing the validation characteristics of limit of detection and specificity. It also follows the European Pharmacopoeia guidelines and Food and Drug Administration (FDA) requirements.

  9. Fully Disposable Manufacturing Concepts for Clinical and Commercial Manufacturing and Ballroom Concepts.

    PubMed

    Boedeker, Berthold; Goldstein, Adam; Mahajan, Ekta

    2017-11-04

    The availability and use of pre-sterilized disposables has greatly changed the methods used in biopharmaceuticals development and production, particularly from mammalian cell culture. Nowadays, almost all process steps from cell expansion, fermentation, cell removal, and purification to formulation and storage of drug substances can be carried out in disposables, although there are still limitations with single-use technologies, particularly in the areas of pretesting and quality control of disposables, bag and connections standardization and qualification, extractables and leachables (E/L) validation, and dependency on individual vendors. The current status of single-use technologies is summarized for all process unit operations using a standard mAb process as an example. In addition, current pros and cons of using disposables are addressed in a comparative way, including quality control and E/L validation.The continuing progress in developing single-use technologies has an important impact on manufacturing facilities, resulting in much faster, less expensive and simpler plant design, start-up, and operation, because cell culture process steps are no longer performed in hard-piped unit operations. This leads to simpler operations in a lab-like environment. Overall it enriches the current landscape of available facilities from standard hard-piped to hard-piped/disposables hybrid to completely single-use-based production plants using the current segregation and containment concept. At the top, disposables in combination with completely and functionally closed systems facilitate a new, revolutionary design of ballroom facilities without or with much less segregation, which enables us to perform good manufacturing practice manufacturing of different products simultaneously in unclassified but controlled areas.Finally, single-use processing in lab-like shell facilities is a big enabler of transferring and establishing production in emergent countries, and this is

  10. Conjoint analysis applications in health--a checklist: a report of the ISPOR Good Research Practices for Conjoint Analysis Task Force.

    PubMed

    Bridges, John F P; Hauber, A Brett; Marshall, Deborah; Lloyd, Andrew; Prosser, Lisa A; Regier, Dean A; Johnson, F Reed; Mauskopf, Josephine

    2011-06-01

    The application of conjoint analysis (including discrete-choice experiments and other multiattribute stated-preference methods) in health has increased rapidly over the past decade. A wider acceptance of these methods is limited by an absence of consensus-based methodological standards. The International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Good Research Practices for Conjoint Analysis Task Force was established to identify good research practices for conjoint-analysis applications in health. The task force met regularly to identify the important steps in a conjoint analysis, to discuss good research practices for conjoint analysis, and to develop and refine the key criteria for identifying good research practices. ISPOR members contributed to this process through an extensive consultation process. A final consensus meeting was held to revise the article using these comments, and those of a number of international reviewers. Task force findings are presented as a 10-item checklist covering: 1) research question; 2) attributes and levels; 3) construction of tasks; 4) experimental design; 5) preference elicitation; 6) instrument design; 7) data-collection plan; 8) statistical analyses; 9) results and conclusions; and 10) study presentation. A primary question relating to each of the 10 items is posed, and three sub-questions examine finer issues within items. Although the checklist should not be interpreted as endorsing any specific methodological approach to conjoint analysis, it can facilitate future training activities and discussions of good research practices for the application of conjoint-analysis methods in health care studies. Copyright © 2011 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

  11. The impact of manufacturing complexity drivers on performance-a preliminary study

    NASA Astrophysics Data System (ADS)

    Huah Leang, Suh; Mahmood, Wan Hasrulnizzam Wan; Rahman, Muhamad Arfauz A.

    2018-03-01

    Manufacturing systems, in pursuit of cost, time and flexibility optimisation are becoming more and more complex, exhibiting a dynamic and nonlinear behaviour. Unpredictability is a distinct characteristic of such behaviour and effects production planning significantly. Therefore, this study was undertaken to investigate the priority level and current achievement of manufacturing performance in Malaysia’s manufacturing industry and the complexity drivers on manufacturing productivity performance. The results showed that Malaysia’s manufacturing industry prioritised product quality and they managed to achieve a good on time delivery performance. However, for other manufacturing performance, there was a difference where the current achievement of manufacturing performances in Malaysia’s manufacturing industry is slightly lower than the priority given to them. The strong correlation of significant value for priority status was observed between efficient production levelling (finished goods) and finish product management while the strong correlation of significant value for current achievement was minimised the number of workstation and factory transportation system. This indicates that complexity drivers have an impact towards manufacturing performance. Consequently, it is necessary to identify complexity drivers to achieve well manufacturing performance.

  12. Evaluating Students' Perspectives about Virtual Classrooms with Regard to Seven Principles of Good Practice

    ERIC Educational Resources Information Center

    Çakýroðlu, Ünal

    2014-01-01

    This study assesses the quality of distance learning (DL) in higher education assessed by considering the Seven Principles of Good Practice (SPGP). The participants were 77 second-year students from the Computer and Instructional Technologies Program (CEIT) of a Faculty of Education in Turkey. A questionnaire was developed in line with the SPGP…

  13. Sharing Good Practice: Prevention and Support Concerning Pupils Presenting Social, Emotional and Behavioural Difficulties.

    ERIC Educational Resources Information Center

    Lloyd, Gwynedd, Ed.; Munn, Pamela, Ed.

    This book is the result of a project to identify and disseminate examples of good practice in providing for children experiencing social, emotional, and behavioral difficulties in schools. The focus is on whole-school or classroom approaches to mainstreaming with experience from teachers of preschool to secondary grades. A major theme is providing…

  14. Decentralized manufacturing of cell and gene therapies: Overcoming challenges and identifying opportunities.

    PubMed

    Harrison, Richard P; Ruck, Steven; Medcalf, Nicholas; Rafiq, Qasim A

    2017-10-01

    Decentralized or "redistributed" manufacturing has the potential to revolutionize the manufacturing approach for cell and gene therapies (CGTs), moving away from the "Fordist" paradigm, delivering health care locally, customized to the end user and, by its very nature, overcoming many of the challenges associated with manufacturing and distribution of high volume goods. In departing from the traditional centralized model of manufacturing, decentralized manufacturing divides production across sites or geographic regions. This paradigm shift imposes significant structural and organisational changes on a business presenting both hidden challenges that must be addressed and opportunities to be embraced. By profoundly adapting business practices, significant advantages can be realized through a democratized value chain, creation of professional-level jobs without geographic restriction to the central hub and a flexibility in response to external pressures and demands. To realize these potential opportunities, however, advances in manufacturing technology and support systems are required, as well as significant changes in the way CGTs are regulated to facilitate multi-site manufacturing. Decentralized manufacturing is likely to be the manufacturing platform of choice for advanced health care therapies-in particular, those with a high degree of personalization. The future success of these promising products will be enhanced by adopting sound business strategies early in development. To realize the benefits that decentralized manufacturing of CGTs has to offer, it is important to examine both the risks and the substantial opportunities present. In this research, we examine both the challenges and the opportunities this shift in business strategy represents in an effort to maximize the success of adoption. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

  15. Material selection in a sustainable manufacturing practice of a badminton racket frame using Elimination and Choice Expressing Reality (ELECTRE) Method

    NASA Astrophysics Data System (ADS)

    Firdhaus Che Hassan, Muhammad; Rosli, Mohd Uzair Mohd; Redzuan, Muhammad Afiq Mohd

    2018-05-01

    Badminton is one of the leading sports in the world. It has its own set of rules on the equipments used and general game play. One of the main equipment used is the badminton racket. Each sections of a badminton racket have its own design requirements and one of it is the racket’s material selection. Therefore, material selection is very important to improve the usage of a badminton racket. This study describes the use of the Elimination and Choice Expressing Reality (ELECTRE) method in the material selection of a badminton racket frame with reference to the sustainable manufacturing practice of the frame. By categorizing the materials of the badminton racket frame according to mechanical, physical, chemical and environmental properties, and further detailed sub criteria were set according to the usage of these frames, the ELECTRE I method was used to determine the dominant material. Out of the six materials usually used in the manufacturing of a badminton racket frame, carbon fibre was the dominant material selected from three out of the four properties which are the mechanical, chemical and most importantly the environmental properties, as to comply with the sustainable manufacturing practice of these frames.

  16. 77 FR 49449 - Food and Drug Administration Clinical Trial Requirements, Compliance, and Good Clinical Practice...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-16

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Food and Drug Administration Clinical Trial Requirements, Compliance, and Good Clinical Practice; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. The Food...

  17. 77 FR 49448 - Food and Drug Administration Clinical Trial Requirements, Compliance, and Good Clinical Practice...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-16

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Food and Drug Administration Clinical Trial Requirements, Compliance, and Good Clinical Practice; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. The Food...

  18. Exposure to rubber fume and rubber process dust in the general rubber goods, tyre manufacturing and retread industries.

    PubMed

    Dost, A A; Redman, D; Cox, G

    2000-08-01

    This study assesses the current patterns and levels of exposure to rubber fume and rubber process dust in the British rubber industry and compares and contrasts the data obtained from the general rubber goods (GRG), retread tire (RT) and new tire (NT) sectors. A total of 179 rubber companies were visited and data were obtained from 52 general rubber goods, 29 retread tire and 7 new tire manufacturers. The survey was conducted using a questionnaire and included a walk-through inspection of the workplace to assess the extent of use of control measures and the nature of work practices being employed. The most recent (predominantly 1995-97) exposure monitoring data for rubber fume and rubber process dust were obtained from these companies; no additional sampling was conducted for the purpose of this study. In addition to the assessment of exposure data, evaluation of occupational hygiene reports for the quality of information and advice was also carried out.A comparison of the median exposures for processes showed that the order of exposure to rubber fume (E, in mg m(-3)) is: E(moulding) (0.40) approximately E(extrusion) (0.33)>E(milling) (0.18) for GRG; E(press) (0. 32)>E(extrusion) (0.19)>E(autoclave) (0.10) for RT; and E(press) (0. 22) approximately E(all other) (0.22) for NT. The order of exposure to rubber fume between sectors was E(GRG) (0.40)>E(RT) (0.32)>E(NT) (0.22). Median exposures to rubber process dust in the GRG was E(weighing) (4.2)>E(mixing) (1.2) approximately E(milling) (0.8) approximately E(extrusion) (0.8) and no significant difference (P=0. 31) between GRG and NT sectors. The findings compare well with the study carried out in the Netherlands [Kromhout et al. (1994), Annals of Occupational Hygiene 38(1), 3-22], and it is suggested that the factors governing the significant differences noted between the three sectors relate principally to the production and task functions and also to the extent of controls employed. Evaluation of occupational

  19. [Special aspects of quality of Tibetan medicines--insights from over 40 years of manufacturing experience in Switzerland].

    PubMed

    Schwabl, Alexandra; Gämperle, Erich

    2013-01-01

    Tibetan recipes are complex formulas from plant and mineral ingredients. Padma Inc. has been producing selected formulas from Tibetan Medicine in Switzerland since more than 40 years. Modern quality standards and Good Manufacturing Practice (GMP) guidelines are followed, ensuring the quality of the raw materials through the manufacturing processes to the finished product. The aim is to provide these valuable formulas to people in the West in a consistently high quality 'made in Switzerland'. The production according to modern quality standards is challenging, draws on many resources, and requires specialized expertise, e.g. in the procurement of raw materials and the quality analysis including pharmacognostic and botanical knowledge.

  20. 16 CFR 700.2 - Date of manufacture.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 16 Commercial Practices 1 2010-01-01 2010-01-01 false Date of manufacture. 700.2 Section 700.2... MAGNUSON-MOSS WARRANTY ACT INTERPRETATIONS OF MAGNUSON-MOSS WARRANTY ACT § 700.2 Date of manufacture... after July 4, 1975. When a consumer purchases repair of a consumer product the date of manufacture of...

  1. Training and Organising People for Flexible Manufacturing. A Literature Review.

    ERIC Educational Resources Information Center

    Cesnich, Janine

    Integrated or flexible manufacturing is a management strategy that integrates training and the organization of people with the modernization of hardware. It would allow Australian manufacturing organizations to produce value-added goods for niche markets and be competitive. Manufacturing organizations that identify and change their production…

  2. 75 FR 78715 - Small Entity Compliance Guide: Current Good Manufacturing Practice in Manufacturing, Packaging...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-16

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0605..., or Holding Operations for Dietary Supplements; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a...

  3. Recent Regulatory Trends in Pharmaceutical Manufacturing and their Impact on the Industry.

    PubMed

    Tabersky, Daniel; Woelfle, Michael; Ruess, Juan-Antonio; Brem, Simon; Brombacher, Stephan

    2018-03-30

    The pharmaceutical industry is one of the most regulated industries in Switzerland. Though the concept of good manufacturing practises (GMP) was implemented for chemical production in the early 1990s, the rules and regulations for our industry are in constant evolution. In this article we will highlight the impact of these changes to the industry using three recent guideline up-dates as examples: the implementation of ICH Q3D 'Guideline for elemental impurities', the EU-GMP Guideline Part III Chapter 'Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities' from 01. June 2015, and the new guidelines to data integrity such as 'PIC/S 041-1 Good Practices for Data Management and Integrity in regulated GMP/GDP environments'. These examples show how scientific approaches help to modernize the control strategies for our products and increase product quality for a better patient safety. The requirements of data integrity regulations are also of interest to industries and universities not working under GxP requirements as they also support the business to improve data quality (traceability) for patent applications, and reduce risk of data falsification.

  4. Scalable microcarrier-based manufacturing of mesenchymal stem/stromal cells.

    PubMed

    de Soure, António M; Fernandes-Platzgummer, Ana; da Silva, Cláudia L; Cabral, Joaquim M S

    2016-10-20

    Due to their unique features, mesenchymal stem/stromal cells (MSC) have been exploited in clinical settings as therapeutic candidates for the treatment of a variety of diseases. However, the success in obtaining clinically-relevant MSC numbers for cell-based therapies is dependent on efficient isolation and ex vivo expansion protocols, able to comply with good manufacturing practices (GMP). In this context, the 2-dimensional static culture systems typically used for the expansion of these cells present several limitations that may lead to reduced cell numbers and compromise cell functions. Furthermore, many studies in the literature report the expansion of MSC using fetal bovine serum (FBS)-supplemented medium, which has been critically rated by regulatory agencies. Alternative platforms for the scalable manufacturing of MSC have been developed, namely using microcarriers in bioreactors, with also a considerable number of studies now reporting the production of MSC using xenogeneic/serum-free medium formulations. In this review we provide a comprehensive overview on the scalable manufacturing of human mesenchymal stem/stromal cells, depicting the various steps involved in the process from cell isolation to ex vivo expansion, using different cell tissue sources and culture medium formulations and exploiting bioprocess engineering tools namely microcarrier technology and bioreactors. Copyright © 2016 Elsevier B.V. All rights reserved.

  5. 21 CFR 184.1101 - Diacetyl tartaric acid esters of mono- and diglycerides.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... used in food with no limitation other than current good manufacturing practice. The affirmation of this... following current good manufacturing practice conditions of use: (1) The ingredient is used in food as an... levels not to exceed current good manufacturing practice: baked goods and baking mixes as defined in...

  6. 21 CFR 184.1101 - Diacetyl tartaric acid esters of mono- and diglycerides.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... used in food with no limitation other than current good manufacturing practice. The affirmation of this... following current good manufacturing practice conditions of use: (1) The ingredient is used in food as an... levels not to exceed current good manufacturing practice: baked goods and baking mixes as defined in...

  7. Virtual manufacturing in reality

    NASA Astrophysics Data System (ADS)

    Papstel, Jyri; Saks, Alo

    2000-10-01

    SMEs play an important role in manufacturing industry. But from time to time there is a shortage in resources to complete the particular order in time. Number of systems is introduced to produce digital information in order to support product and process development activities. Main problem is lack of opportunity for direct data transition within design system modules when needed temporary extension of design capacity (virtuality) or to implement integrated concurrent product development principles. The planning experience in the field is weakly used as well. The concept of virtual manufacturing is a supporting idea to solve this problem. At the same time a number of practical problems should be solved like information conformity, data transfer, unified technological concepts acceptation etc. In the present paper the proposed ways to solve the practical problems of virtual manufacturing are described. General objective is to introduce the knowledge-based CAPP system as missing module for Virtual Manufacturing in the selected product domain. Surface-centered planning concept based on STEP- based modeling principles, and knowledge-based process planning methodology will be used to gain the objectives. As a result the planning module supplied by design data with direct access, and supporting advising environment is expected. Mould producing SME would be as test basis.

  8. Control Systems Engineering in Continuous Pharmaceutical Manufacturing May 20-21, 2014 Continuous Manufacturing Symposium.

    PubMed

    Myerson, Allan S; Krumme, Markus; Nasr, Moheb; Thomas, Hayden; Braatz, Richard D

    2015-03-01

    drug manufacturing that are easily transportable to industry. Industry can facilitate the move to continuous manufacturing by working with universities on the conception of new continuous pharmaceutical manufacturing process unit operations that have the potential to make major improvements in product quality, controllability, or reduced capital and/or operating costs. Regulatory bodies should ensure that: (1) regulations and regulatory practices promote, and do not derail, the development and implementation of continuous manufacturing and control systems engineering approaches; (2) the individuals who approve specific regulatory filings are sufficiently trained to make good decisions regarding control systems approaches; (3) provide regulatory clarity and eliminate/reduce regulatory risks; (4) financially support the development of high-quality training materials for use of undergraduate students, graduate students, industrial employees, and regulatory staff; (5) enhance the training of their own technical staff by financially supporting joint research projects with universities in the development of continuous pharmaceutical manufacturing processes and the associated control systems engineering theory, numerical algorithms, and software; and (6) strongly encourage the federal agencies that support research to fund these research areas. © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association. © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association.

  9. Topical otic drugs in a multi-purpose manufacturing facility: a guide on determination and application of permitted daily exposure (PDE).

    PubMed

    Wiesner, Lisa; Prause, Maarten; Lovsin Barle, Ester

    2018-03-01

    Due to newly introduced EU GMP (Good Manufacturing Practice) guideline for Medicinal Products for Human and Veterinary use, product specific permitted daily exposure (PDE) for toxicological evaluation in multi-purpose facilities are required within a documented process for risk assessment. European Medicines Agency (EMA) guidance on setting PDE limits so far focused on systemic administration routes such as intravenous (IV), oral or inhalation. This article provides guidance on setting PDE values for risk management purposes in multi-purpose facilities for active pharmaceutical ingredients (APIs) applied as topical otic drugs to the outer ear canal. The therewith determined PDE otic, is used for the calculation of maximum safe carry-over (MSC) in manufacturing scenarios where a topical otic product is manufactured followed by another topical otic product.

  10. CT-assisted agile manufacturing

    NASA Astrophysics Data System (ADS)

    Stanley, James H.; Yancey, Robert N.

    1996-11-01

    The next century will witness at least two great revolutions in the way goods are produced. First, workers will use the medium of virtual reality in all aspects of marketing, research, development, prototyping, manufacturing, sales and service. Second, market forces will drive manufacturing towards small-lot production and just-in-time delivery. Already, we can discern the merging of these megatrends into what some are calling agile manufacturing. Under this new paradigm, parts and processes will be designed and engineered within the mind of a computer, tooled and manufactured by the offspring of today's rapid prototyping equipment, and evaluated for performance and reliability by advanced nondestructive evaluation (NDE) techniques and sophisticated computational models. Computed tomography (CT) is the premier example of an NDE method suitable for future agile manufacturing activities. It is the only modality that provides convenient access to the full suite of engineering data that users will need to avail themselves of computer- aided design, computer-aided manufacturing, and computer- aided engineering capabilities, as well as newly emerging reverse engineering, rapid prototyping and solid freeform fabrication technologies. As such, CT is assured a central, utilitarian role in future industrial operations. An overview of this exciting future for industrial CT is presented.

  11. Microscopic or occult hematuria, when reflex testing is not good laboratory practice.

    PubMed

    Froom, Paul; Barak, Mira

    2010-01-01

    Consensus opinion suggests that hematuria found by dipstick and not confirmed on microscopic examination (<2 erythrocytes per high power field) signifies a false-positive reagent strip test result. Standard practice is to repeat the dipstick test several days later and if still positive to confirm by microscopic examination. If discordant results are obtained, experts recommend reflex testing for urinary myoglobin and hemoglobin concentrations. The question is whether or not this approach represents good laboratory practice. These recommendations are not evidence based. We conclude that the reference range for red blood cells on the reagent strip should be increased to 25x10(6) cells/L for young men, and 50x10(6) cells/L for the rest of the adult population, ranges consistent with flow cytometry reports. Confirmation reflex testing using tests that have inferior sensitivity, precision and probably accuracy is not recommended.

  12. The Utilization of the Seven Principles for Good Practices of Full-Time and Adjunct Faculty in Teaching Health & Science in Community Colleges

    ERIC Educational Resources Information Center

    Musaitif, Linda M.

    2013-01-01

    Purpose: The purpose of this study was to determine the degree to which undergraduate full-time and adjunct faculty members in the health and science programs at community colleges in Southern California utilize the seven principles of good practice as measured by the Faculty Inventory of the Seven Principles for Good Practice in Undergraduate…

  13. Estimating the harms and benefits of prostate cancer screening as used in common practice versus recommended good practice: A microsimulation screening analysis.

    PubMed

    Carlsson, Sigrid V; de Carvalho, Tiago M; Roobol, Monique J; Hugosson, Jonas; Auvinen, Anssi; Kwiatkowski, Maciej; Villers, Arnauld; Zappa, Marco; Nelen, Vera; Páez, Alvaro; Eastham, James A; Lilja, Hans; de Koning, Harry J; Vickers, Andrew J; Heijnsdijk, Eveline A M

    2016-11-15

    Prostate-specific antigen (PSA) screening and concomitant treatment can be implemented in several ways. The authors investigated how the net benefit of PSA screening varies between common practice versus "good practice." Microsimulation screening analysis (MISCAN) was used to evaluate the effect on quality-adjusted life-years (QALYs) if 4 recommendations were followed: limited screening in older men, selective biopsy in men with elevated PSA, active surveillance for low-risk tumors, and treatment preferentially delivered at high-volume centers. Outcomes were compared with a base model in which annual screening started at ages 55 to 69 years and were simulated using data from the European Randomized Study of Screening for Prostate Cancer. In terms of QALYs gained compared with no screening, for 1000 screened men who were followed over their lifetime, recommended good practice led to 73 life-years (LYs) and 74 QALYs gained compared with 73 LYs and 56 QALYs for the base model. In contrast, common practice led to 78 LYs gained but only 19 QALYs gained, for a greater than 75% relative reduction in QALYs gained from unadjusted LYs gained. The poor outcomes for common practice were influenced predominantly by the use of aggressive treatment for men with low-risk disease, and PSA testing in older men also strongly reduced potential QALY gains. Commonly used PSA screening and treatment practices are associated with little net benefit. Following a few straightforward clinical recommendations, particularly greater use of active surveillance for low-risk disease and reducing screening in older men, would lead to an almost 4-fold increase in the net benefit of prostate cancer screening. Cancer 2016;122:3386-3393. © 2016 American Cancer Society. © 2016 American Cancer Society.

  14. 77 FR 71804 - Request for Notification From Industry Organizations Interested in Participating in the Selection...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-04

    ... Representatives on the Device Good Manufacturing Practice Advisory Committee AGENCY: Food and Drug Administration... Device Good Manufacturing Practice Advisory Committee (DGMPAC) in the Center for Devices and Radiological... regarding good manufacturing practices governing the methods used in, and the facilities and controls used...

  15. Electroencephalographic neurofeedback: Level of evidence in mental and brain disorders and suggestions for good clinical practice.

    PubMed

    Micoulaud-Franchi, J-A; McGonigal, A; Lopez, R; Daudet, C; Kotwas, I; Bartolomei, F

    2015-12-01

    The technique of electroencephalographic neurofeedback (EEG NF) emerged in the 1970s and is a technique that measures a subject's EEG signal, processes it in real time, extracts a parameter of interest and presents this information in visual or auditory form. The goal is to effectuate a behavioural modification by modulating brain activity. The EEG NF opens new therapeutic possibilities in the fields of psychiatry and neurology. However, the development of EEG NF in clinical practice requires (i) a good level of evidence of therapeutic efficacy of this technique, (ii) a good practice guide for this technique. Firstly, this article investigates selected trials with the following criteria: study design with controlled, randomized, and open or blind protocol, primary endpoint related to the mental and brain disorders treated and assessed with standardized measurement tools, identifiable EEG neurophysiological targets, underpinned by pathophysiological relevance. Trials were found for: epilepsies, migraine, stroke, chronic insomnia, attentional-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, major depressive disorder, anxiety disorders, addictive disorders, psychotic disorders. Secondly, this article investigates the principles of neurofeedback therapy in line with learning theory. Different underlying therapeutic models are presented didactically between two continua: a continuum between implicit and explicit learning and a continuum between the biomedical model (centred on "the disease") and integrative biopsychosocial model of health (centred on "the illness"). The main relevant learning model is to link neurofeedback therapy with the field of cognitive remediation techniques. The methodological specificity of neurofeedback is to be guided by biologically relevant neurophysiological parameters. Guidelines for good clinical practice of EEG NF concerning technical issues of electrophysiology and of learning are suggested. These require validation by

  16. Application of Additive Manufacturing in Oral and Maxillofacial Surgery.

    PubMed

    Farré-Guasch, Elisabet; Wolff, Jan; Helder, Marco N; Schulten, Engelbert A J M; Forouzanfar, Tim; Klein-Nulend, Jenneke

    2015-12-01

    Additive manufacturing is the process of joining materials to create objects from digital 3-dimensional (3D) model data, which is a promising technology in oral and maxillofacial surgery. The management of lost craniofacial tissues owing to congenital abnormalities, trauma, or cancer treatment poses a challenge to oral and maxillofacial surgeons. Many strategies have been proposed for the management of such defects, but autogenous bone grafts remain the gold standard for reconstructive bone surgery. Nevertheless, cell-based treatments using adipose stem cells combined with osteoconductive biomaterials or scaffolds have become a promising alternative to autogenous bone grafts. Such treatment protocols often require customized 3D scaffolds that fulfill functional and esthetic requirements, provide adequate blood supply, and meet the load-bearing requirements of the head. Currently, such customized 3D scaffolds are being manufactured using additive manufacturing technology. In this review, 2 of the current and emerging modalities for reconstruction of oral and maxillofacial bone defects are highlighted and discussed, namely human maxillary sinus floor elevation as a valid model to test bone tissue-engineering approaches enabling the application of 1-step surgical procedures and seeding of Good Manufacturing Practice-level adipose stem cells on computer-aided manufactured scaffolds to reconstruct large bone defects in a 2-step surgical procedure, in which cells are expanded ex vivo and seeded on resorbable scaffolds before implantation. Furthermore, imaging-guided tissue-engineering technologies to predetermine the surgical location and to facilitate the manufacturing of custom-made implants that meet the specific patient's demands are discussed. The potential of tissue-engineered constructs designed for the repair of large oral and maxillofacial bone defects in load-bearing situations in a 1-step surgical procedure combining these 2 innovative approaches is

  17. College of American Pathologists Gynecologic Cytopathology Quality Consensus Conference on good laboratory practices in gynecologic cytology: background, rationale, and organization.

    PubMed

    Tworek, Joseph A; Henry, Michael R; Blond, Barbara; Jones, Bruce Allen

    2013-02-01

    Gynecologic cytopathology is a heavily regulated field, with Clinical Laboratory Improvement Amendments of 1988 mandating the collection of many quality metrics. There is a lack of consensus regarding methods to collect, monitor, and benchmark these data and how these data should be used in a quality assurance program. Furthermore, the introduction of human papilloma virus testing and proficiency testing has provided more data to monitor. To determine good laboratory practices in quality assurance of gynecologic cytopathology. Data were collected through a written survey consisting of 98 questions submitted to 1245 Clinical Laboratory Improvement Amendments-licensed or Department of Defense laboratories. There were 541 usable responses. Additional input was sought through a Web posting of results and questions on the College of American Pathologists Web site. Four senior authors who authored the survey and 28 cytopathologists and cytotechnologists were assigned to 5 working groups to analyze data and present statements on good laboratory practices in gynecologic cytopathology at the College of American Pathologists Gynecologic Cytopathology Quality Consensus Conference. Ninety-eight attendees at the College of American Pathologists Gynecologic Cytopathology Quality Consensus Conference discussed and voted on good laboratory practice statements to obtain consensus. This paper describes the rationale, background, process, and strengths and limitations of a series of papers that summarize good laboratory practice statements in quality assurance in gynecologic cytopathology.

  18. 21 CFR 184.1452 - Manganese gluconate.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... used in food with no limitation other than current good manufacturing practice. The affirmation of this... following current good manufacturing practice conditions of use: (1) The ingredient is used as a nutrient... levels not to exceed current good manufacturing practice: baked goods as defined in § 170.3(n)(1) of this...

  19. Good laboratory practices for biochemical genetic testing and newborn screening for inherited metabolic disorders.

    PubMed

    2012-04-06

    Biochemical genetic testing and newborn screening are essential laboratory services for the screening, detection, diagnosis, and monitoring of inborn errors of metabolism or inherited metabolic disorders. Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations, laboratory testing is categorized on the basis of the level of testing complexity as either waived (i.e., from routine regulatory oversight) or nonwaived testing (which includes tests of moderate and high complexity). Laboratories that perform biochemical genetic testing are required by CLIA regulations to meet the general quality systems requirements for nonwaived testing and the personnel requirements for high-complexity testing. Laboratories that perform public health newborn screening are subject to the same CLIA regulations and applicable state requirements. As the number of inherited metabolic diseases that are included in state-based newborn screening programs continues to increase, ensuring the quality of performance and delivery of testing services remains a continuous challenge not only for public health laboratories and other newborn screening facilities but also for biochemical genetic testing laboratories. To help ensure the quality of laboratory testing, CDC collaborated with the Centers for Medicare & Medicaid Services, the Food and Drug Administration, the Health Resources and Services Administration, and the National Institutes of Health to develop guidelines for laboratories to meet CLIA requirements and apply additional quality assurance measures for these areas of genetic testing. This report provides recommendations for good laboratory practices that were developed based on recommendations from the Clinical Laboratory Improvement Advisory Committee, with additional input from the Secretary's Advisory Committee on Genetics, Health, and Society; the Secretary's Advisory Committee on Heritable Disorders in Newborns and Children; and representatives of newborn

  20. Sponsorship in non-commercial clinical trials: definitions, challenges and the role of Good Clinical Practices guidelines.

    PubMed

    Ravinetto, Raffaella; De Nys, Katelijne; Boelaert, Marleen; Diro, Ermias; Meintjes, Graeme; Adoke, Yeka; Tagbor, Harry; Casteels, Minne

    2015-12-30

    Non-commercial clinical research plays an increasingly essential role for global health. Multiple partners join in international consortia that operate under the limited timeframe of a specific funding period. One organisation (the sponsor) designs and carries out the trial in collaboration with research partners, and is ultimately responsible for the trial's scientific, ethical, regulatory and legal aspects, while another organization, generally in the North (the funder), provides the external funding and sets funding conditions. Even if external funding mechanisms are key for most non-commercial research, the dependence on an external funder's policies may heavily influence the choices of a sponsor. In addition, the competition for accessing the available external funds is great, and non-commercial sponsors may not be in a position to discuss or refuse standard conditions set by a funder. To see whether the current definitions adequately address the intricacies of sponsorship in externally-funded trials, we looked at how a "sponsor" of clinical trials is defined in selected international guidelines, with particular focus on international Good Clinical Practices codes, and in selected European and African regulations/legislations. Our limited analysis suggests that the sponsors definition from the 1995 WHO Good Clinical Practices code has been integrated as such into many legislations, guidelines and regulations, and that it is not adequate to cover today's reality of funding arrangements in global health, where the legal responsibility and the funding source are de facto split. In agreement with other groups, we suggest that the international Good Clinical Practices codes should be updated to reflect the reality of non-commercial clinical research. In particular, they should explicitly include the distinction between commercial and non-commercial sponsors, and provide guidance to non-commercial sponsors for negotiating with external funding agencies and other

  1. Printing Processes Used to Manufacture Photovoltaic Solar Cells

    ERIC Educational Resources Information Center

    Rardin, Tina E.; Xu, Renmei

    2011-01-01

    There is a growing need for renewable energy sources, and solar power is a good option in many instances. Photovoltaic solar panels are now being manufactured via various methods, and different printing processes are being incorporated into the manufacturing process. Screen printing has been used most prevalently in the printing process to make…

  2. 16 CFR 1211.24 - Product certification and labeling by manufacturers.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Product certification and labeling by manufacturers. 1211.24 Section 1211.24 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT... § 1211.24 Product certification and labeling by manufacturers. (a) Form of permanent label of...

  3. Differences in the design and sale of e-cigarettes by cigarette manufacturers and non-cigarette manufacturers in the USA.

    PubMed

    Seidenberg, Andrew B; Jo, Catherine L; Ribisl, Kurt M

    2016-04-01

    Three categories of e-cigarette brands have emerged within the US market: e-cigarette brands developed by cigarette manufacturers, brands acquired by cigarette manufacturers and brands with no cigarette manufacturer affiliation. In the absence of federal regulatory oversight of e-cigarettes, we assessed differences in e-cigarette products and sales practices across these categories. Brand websites for top-selling e-cigarette brands from each of these categories were examined in October of 2015 to compare website access restrictions, online sales practices and products sold, including e-cigarette model type (eg, 'cigalike' vs advanced systems) and options available (eg, flavoured, nicotine free). Website access to brands developed by cigarette manufacturers was restricted to users aged 21 years or older, and one website required user registration. In addition, these brands were exclusively reusable/rechargeable 'cigalikes.' Limited flavour options were available for these products, and nicotine-free options were not sold. In contrast, brands acquired by cigarette manufacturers and brands with no cigarette manufacturer affiliation generally required website visitors to be 18, offered a nicotine-free option, and most offered disposable products and an array of flavoured products (eg, fruit/candy flavours). This exploratory study finds differences in e-cigarette products and sales practices across these three e-cigarette brand categories, with brands developed by cigarette manufacturers adopting a particularly distinctive product and sales strategy. Anticipated regulation of e-cigarettes in the USA may be influencing these product and sales decisions. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  4. IDENTIFYING PERFORMANCE ASSURANCE CHALLENGES FOR SMART MANUFACTURING.

    PubMed

    Helu, Moneer; Morris, Katherine; Jung, Kiwook; Lyons, Kevin; Leong, Swee

    2015-10-01

    Smart manufacturing has the potential to address many of the challenges faced by industry. However, the manufacturing community often needs assistance to leverage available technologies to improve their systems. To assure the performance of these technologies, this paper proposes a shared knowledge base that collects problem areas, solutions, and best practices for manufacturing technology. An Implementation Risk Assessment Framework (IRAF) is also described to identify the primary weaknesses of technologies in specific manufacturing contexts. Such approaches have the potential to stimulate new ideas and drive standardization activities critical to scale up and deploy smart manufacturing technologies successfully and quickly.

  5. IDENTIFYING PERFORMANCE ASSURANCE CHALLENGES FOR SMART MANUFACTURING

    PubMed Central

    Helu, Moneer; Morris, Katherine; Jung, Kiwook; Lyons, Kevin; Leong, Swee

    2015-01-01

    Smart manufacturing has the potential to address many of the challenges faced by industry. However, the manufacturing community often needs assistance to leverage available technologies to improve their systems. To assure the performance of these technologies, this paper proposes a shared knowledge base that collects problem areas, solutions, and best practices for manufacturing technology. An Implementation Risk Assessment Framework (IRAF) is also described to identify the primary weaknesses of technologies in specific manufacturing contexts. Such approaches have the potential to stimulate new ideas and drive standardization activities critical to scale up and deploy smart manufacturing technologies successfully and quickly. PMID:26783512

  6. SAPCO: From Good to Great

    ERIC Educational Resources Information Center

    Alsaif, Saleh; Edinger, Brandon; Kodathala, Teja; Korzaan, Melinda

    2017-01-01

    Saudi Arabian Petrochemical Company (SAPCO), a petrochemicals manufacturer, has decided to make some major internal changes to gain increased market share and continue its success. It has been easy going for some time now, and business has been very good, but in order to take that next step, SAPCO needs to attain the Responsible Care…

  7. 29 CFR 779.332 - Resale of goods in an altered form or as parts or ingredients of other goods or services.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... the sale of goods which will be resold in their original form, in an altered form, or as a part or ingredient of another article. A sale of goods which the seller knows, or has reasonable cause to believe, will be resold after processing or manufacture is a sale for resale. Thus, sales of parts with the...

  8. Model competencies in regulatory therapeutic product assessment: Health Canada's good review guiding principles as a reviewing community's code of intellectual conduct.

    PubMed

    Lim, Robyn R

    2007-08-01

    This article describes some work from the Therapeutic Products Directorate of Health Canada regarding Good Review Practices (GRP). Background information is provided on the Therapeutic Products Directorate (TPD) and its regulatory activities regarding drug and medical device assessment in both the pre- and post-market setting. The TPD Good Review Guiding Principles (GRGP) are described which include a Definition of a Good Therapeutic Product Regulatory Review, Ten Hallmarks of a Good Therapeutic Product Regulatory Review and Ten Precepts. Analysis of the guiding principles discusses possible linkages between the guiding principles and intellectual virtues. Through this analysis an hypothesis is developed that the guiding principles outline a code of intellectual conduct for Health Canada's reviewers of evidence for efficacy, safety, manufacturing quality and benefit-risk regarding therapeutic products. Opportunities to advance therapeutic product regulatory review as a scientific discipline in its own right and to acknowledge that these reviewers constitute a specific community of practice are discussed. Integration of intellectual and ethical approaches across therapeutic product review sectors is also suggested.

  9. Good practices in normal childbirth: reliability analysis of an instrument by Cronbach's Alpha.

    PubMed

    Gottems, Leila Bernarda Donato; Carvalho, Elisabete Mesquita Peres De; Guilhem, Dirce; Pires, Maria Raquel Gomes Maia

    2018-01-01

    to analyze the internal consistency of the evaluation instrument of the adherence to the good practices of childbirth and birth care in the professionals, through Cronbach's Alpha Coefficient for each of the dimensions and for the total instrument. this is a descriptive and cross-sectional study performed in obstetric centers of eleven public hospitals in the Federal District, with a questionnaire applied to 261 professionals who worked in the delivery care. The study was attended by 261 professionals, 42.5% (111) nurses and 57.5% (150) physicians. The reliability evaluation of the instrument by the Cronbach Alfa resulted in 0.53, 0.78 and 0.76 for dimensions 1, 2 and 3, after debugging that resulted in the exclusion of 11 items. the instrument obtained Cronbach's alpha of 0.80. There is a need for improvement in the items of dimension 1 that refer to attitudes, knowledge, and practices of the organization of the network of care to gestation, childbirth, and birth. However, it can be applied in the way it is used to evaluate practices based on scientific evidence of childbirth care.

  10. A Critical Analysis of the INQAAHE Guidelines of Good Practice for Higher Education Quality Assurance Agencies

    ERIC Educational Resources Information Center

    Blackmur, Douglas

    2008-01-01

    The International Network of Quality Assurance Agencies in Higher Education's Guidelines of Good Practice by higher education quality assurance agencies need substantial revision before they can be considered adequate by stakeholders in any national higher education system. Various revisions are proposed in this article. But the International…

  11. 77 FR 36277 - Academic Development of a Training Program for Good Laboratory Practices in High Containment...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-18

    ... requirements in high and maximum biocontainment, scientists working in this environment and FDA staff who will...] Academic Development of a Training Program for Good Laboratory Practices in High Containment Environments... Containment Environments (U24).'' In this FOA, FDA announces its intention to accept and consider a single...

  12. Practical Strategies for Integrating Final Ecosystem Goods and ...

    EPA Pesticide Factsheets

    The concept of Final Ecosystem Goods and Services (FEGS) explicitly connects ecosystem services to the people that benefit from them. This report presents a number of practical strategies for incorporating FEGS, and more broadly ecosystem services, into the decision-making process. Whether a decision process is in early or late stages, or whether a process includes informal or formal decision analysis, there are multiple points where ecosystem services concepts can be integrated. This report uses Structured Decision Making (SDM) as an organizing framework to illustrate the role ecosystem services can play in a values-focused decision-process, including: • Clarifying the decision context: Ecosystem services can help clarify the potential impacts of an issue on natural resources together with their spatial and temporal extent based on supply and delivery of those services, and help identify beneficiaries for inclusion as stakeholders in the deliberative process. • Defining objectives and performance measures: Ecosystem services may directly represent stakeholder objectives, or may be means toward achieving other objectives. • Creating alternatives: Ecosystem services can bring to light creative alternatives for achieving other social, economic, health, or general well-being objectives. • Estimating consequences: Ecosystem services assessments can implement ecological production functions (EPFs) and ecological benefits functions (EBFs) to link decision alt

  13. Bionic Manufacturing: Towards Cyborg Cells and Sentient Microbots.

    PubMed

    Srivastava, Sarvesh Kumar; Yadav, Vikramaditya G

    2018-05-01

    Bio-inspired engineering applies biological design principles towards developing engineering solutions but is not practical as a manufacturing paradigm. We advocate 'bionic manufacturing', a synergistic fusion of biotic and abiotic components, to transition away from bio-inspiration toward bio-augmentation to address current limitations in bio-inspired manufacturing. Copyright © 2017 Elsevier Ltd. All rights reserved.

  14. Training Welders in Advanced Manufacturing Philosophies Nets Employability

    ERIC Educational Resources Information Center

    Wilson, Kristin

    2011-01-01

    As of September 2010, the U.S. manufacturing sector grew for the 14th consecutive month, leading some economists to speculate that, as with the Great Depression, American manufacturing will lead the economy out of the recession. It is a little bit of good news in a long stream of depressing employment reports. Career and technical educators…

  15. Clinical-Grade Manufacturing of Therapeutic Human Mesenchymal Stem/Stromal Cells in Microcarrier-Based Culture Systems.

    PubMed

    Fernandes-Platzgummer, Ana; Carmelo, Joana G; da Silva, Cláudia Lobato; Cabral, Joaquim M S

    2016-01-01

    The therapeutic potential of mesenchymal stem/stromal cells (MSC) has triggered the need for high cell doses in a vast number of clinical applications. This demand requires the development of good manufacturing practices (GMP)-compliant ex vivo expansion protocols that should be effective to deliver a robust and reproducible supply of clinical-grade cells in a safe and cost-effective manner. Controlled stirred-tank bioreactor systems under xenogeneic (xeno)-free culture conditions offer ideal settings to develop and optimize cell manufacturing to meet the standards and needs of human MSC for cellular therapies. Herein we describe two microcarrier-based stirred culture systems using spinner flasks and controlled stirred-tank bioreactors under xeno-free conditions for the efficient ex vivo expansion of human bone marrow and adipose tissue-derived MSC.

  16. Report to the President on Ensuring American Leadership in Advanced Manufacturing

    ERIC Educational Resources Information Center

    Anderson, Alan

    2011-01-01

    The United States has long thrived as a result of its ability to manufacture goods and sell them to global markets. Manufacturing activity has supported its economic growth, leading the Nation's exports and employing millions of Americans. The manufacturing sector has also driven knowledge production and innovation in the United States, by…

  17. Good Practices in Undergraduate Education from the Students' and Faculty's View: Consensus or Disagreement. AIR 1996 Annual Forum Paper.

    ERIC Educational Resources Information Center

    Negron-Morales, Patricia; And Others

    This study examined teaching practices in undergraduate education by surveying 180 undergraduate students and 29 faculty, most in the school of education, at the Rio Piedras Campus of the University of Puerto Rico. Factors investigated include: (1) degree of agreement between faculty and students on good teaching practices; (2) relationship…

  18. Team Science Approach to Developing Consensus on Research Good Practices for Practice-Based Research Networks: A Case Study.

    PubMed

    Campbell-Voytal, Kimberly; Daly, Jeanette M; Nagykaldi, Zsolt J; Aspy, Cheryl B; Dolor, Rowena J; Fagnan, Lyle J; Levy, Barcey T; Palac, Hannah L; Michaels, LeAnn; Patterson, V Beth; Kano, Miria; Smith, Paul D; Sussman, Andrew L; Williams, Robert; Sterling, Pamela; O'Beirne, Maeve; Neale, Anne Victoria

    2015-12-01

    Using peer learning strategies, seven experienced PBRNs working in collaborative teams articulated procedures for PBRN Research Good Practices (PRGPs). The PRGPs is a PBRN-specific resource to facilitate PBRN management and staff training, to promote adherence to study protocols, and to increase validity and generalizability of study findings. This paper describes the team science processes which culminated in the PRGPs. Skilled facilitators used team science strategies and methods from the Technology of Participation (ToP®), and the Consensus Workshop Method to support teams to codify diverse research expertise in practice-based research. The participatory nature of "sense-making" moved through identifiable stages. Lessons learned include (1) team input into the scope of the final outcome proved vital to project relevance; (2) PBRNs with diverse domains of research expertise contributed broad knowledge on each topic; and (3) ToP® structured facilitation techniques were critical for establishing trust and clarifying the "sense-making" process. © 2015 Wiley Periodicals, Inc.

  19. 21 CFR 184.1449 - Manganese citrate.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing... good manufacturing practice: baked goods as defined in § 170.3(n)(1) of this chapter; nonalcoholic...

  20. 21 CFR 184.1449 - Manganese citrate.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing... good manufacturing practice: baked goods as defined in § 170.3(n)(1) of this chapter; nonalcoholic...

  1. 21 CFR 184.1449 - Manganese citrate.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing... good manufacturing practice: baked goods as defined in § 170.3(n)(1) of this chapter; nonalcoholic...

  2. 21 CFR 184.1449 - Manganese citrate.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing... good manufacturing practice: baked goods as defined in § 170.3(n)(1) of this chapter; nonalcoholic...

  3. 16 CFR 1204.5 - Manufacturer's instructions.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Manufacturer's instructions. 1204.5 Section 1204.5 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS SAFETY STANDARD FOR OMNIDIRECTIONAL CITIZENS BAND BASE STATION ANTENNAS The Standard § 1204.5...

  4. Additively manufactured porous tantalum implants.

    PubMed

    Wauthle, Ruben; van der Stok, Johan; Amin Yavari, Saber; Van Humbeeck, Jan; Kruth, Jean-Pierre; Zadpoor, Amir Abbas; Weinans, Harrie; Mulier, Michiel; Schrooten, Jan

    2015-03-01

    The medical device industry's interest in open porous, metallic biomaterials has increased in response to additive manufacturing techniques enabling the production of complex shapes that cannot be produced with conventional techniques. Tantalum is an important metal for medical devices because of its good biocompatibility. In this study selective laser melting technology was used for the first time to manufacture highly porous pure tantalum implants with fully interconnected open pores. The architecture of the porous structure in combination with the material properties of tantalum result in mechanical properties close to those of human bone and allow for bone ingrowth. The bone regeneration performance of the porous tantalum was evaluated in vivo using an orthotopic load-bearing bone defect model in the rat femur. After 12 weeks, substantial bone ingrowth, good quality of the regenerated bone and a strong, functional implant-bone interface connection were observed. Compared to identical porous Ti-6Al-4V structures, laser-melted tantalum shows excellent osteoconductive properties, has a higher normalized fatigue strength and allows for more plastic deformation due to its high ductility. It is therefore concluded that this is a first step towards a new generation of open porous tantalum implants manufactured using selective laser melting. Copyright © 2014 Acta Materialia Inc. Published by Elsevier Ltd. All rights reserved.

  5. Establishing good collaborative research practices in the responsible conduct of research in nursing science.

    PubMed

    Ulrich, Connie M; Wallen, Gwenyth R; Cui, Naixue; Chittams, Jesse; Sweet, Monica; Plemmons, Dena

    2015-01-01

    Team science is advocated to speed the pace of scientific discovery, yet the goals of collaborative practice in nursing science and the responsibilities of nurse stakeholders are sparse and inconclusive. The purpose of this study was to examine nurse scientists' views on collaborative research as part of a larger study on standards of scientific conduct. Web-based descriptive survey of nurse scientists randomly selected from 50 doctoral graduate programs in the United States. Nearly forty percent of nurse respondents were not able to identify good collaborative practices for the discipline; more than three quarters did not know of any published guidelines available to them. Successful research collaborations were challenged by different expectations of authorship and data ownership, lack of timeliness and communication, poorly defined roles and responsibilities, language barriers, and when they involve junior and senior faculty working together on a project. Individual and organizational standards, practices, and policies for collaborative research needs clarification within the discipline. Copyright © 2015 Elsevier Inc. All rights reserved.

  6. Ceramic Stereolithography: Additive Manufacturing for Ceramics by Photopolymerization

    NASA Astrophysics Data System (ADS)

    Halloran, John W.

    2016-07-01

    Ceramic stereolithography and related additive manufacturing methods involving photopolymerization of ceramic powder suspensions are reviewed in terms of the capabilities of current devices. The practical fundamentals of the cure depth, cure width, and cure profile are related to the optical properties of the monomer, ceramic, and photo-active components. Postpolymerization steps, including harvesting and cleaning the objects, binder burnout, and sintering, are discussed and compared with conventional methods. The prospects for practical manufacturing are discussed.

  7. The Euroversity Good Practice Framework (EGPF) and Its Application to Minority Languages and Elder Learners

    ERIC Educational Resources Information Center

    Motteram, Gary; Koenraad, Ton; Outakoski, Hanna; Jauregi, Kristi; Molka-Danielsen, Judith; Schneider, Christel

    2014-01-01

    The Euroversity Network project (2011-2014) has built a Good Practice Framework (GPF) that functions as a heuristic for course and activity designers wishing to develop courses and other materials for use in a range of virtual worlds. This framework has been tested with a number of courses during the running of the project and the aim is that it…

  8. 19 CFR 134.35 - Articles substantially changed by manufacture.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 19 Customs Duties 1 2012-04-01 2012-04-01 false Articles substantially changed by manufacture. 134...; DEPARTMENT OF THE TREASURY COUNTRY OF ORIGIN MARKING Exceptions to Marking Requirements § 134.35 Articles substantially changed by manufacture. (a) Articles other than goods of a NAFTA country. An article used in the...

  9. 19 CFR 134.35 - Articles substantially changed by manufacture.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 19 Customs Duties 1 2010-04-01 2010-04-01 false Articles substantially changed by manufacture. 134...; DEPARTMENT OF THE TREASURY COUNTRY OF ORIGIN MARKING Exceptions to Marking Requirements § 134.35 Articles substantially changed by manufacture. (a) Articles other than goods of a NAFTA country. An article used in the...

  10. 19 CFR 134.35 - Articles substantially changed by manufacture.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 19 Customs Duties 1 2011-04-01 2011-04-01 false Articles substantially changed by manufacture. 134...; DEPARTMENT OF THE TREASURY COUNTRY OF ORIGIN MARKING Exceptions to Marking Requirements § 134.35 Articles substantially changed by manufacture. (a) Articles other than goods of a NAFTA country. An article used in the...

  11. Applying the Seven Principles of Good Practice: Technology as a Lever--In an Online Research Course

    ERIC Educational Resources Information Center

    Johnson, Sherryl

    2014-01-01

    This article provides an overview of the seven principles of good practice with emphasis on the implementation of technology in an online healthcare research class in a southwest Georgia (United States) university. The seven principles are outlined using various elements of the online course. Historical and philosophical reasoning are applied to…

  12. Revised guidelines for good practice in IVF laboratories (2015).

    PubMed

    De los Santos, Maria José; Apter, Susanna; Coticchio, Giovanni; Debrock, Sophie; Lundin, Kersti; Plancha, Carlos E; Prados, Fernando; Rienzi, Laura; Verheyen, Greta; Woodward, Bryan; Vermeulen, Nathalie

    2016-04-01

    Which recommendations can be provided by the European Society of Human Reproduction and Embryology Special Interest Group (ESHRE SIG) Embryology to support laboratory specialists in the organization and management of IVF laboratories and the optimization of IVF patient care? Structured in 13 sections, the guideline development group formulated recommendations for good practice in the organization and management of IVF laboratories, and for good practice of the specific procedures performed within the IVF laboratory. NA. The guideline was produced by a group of 10 embryologists representing different European countries, settings and levels of expertise. The group evaluated the document of 2008, and based on this assessment, each group member rewrote one or more sections. Two 2-day meetings were organized during which each of the recommendations was discussed and rewritten until consensus within the guideline group was reached. After finalizing the draft, the members of the ESHRE SIG embryology were invited to review the guideline. NA. The guideline provides recommendations on the general organization of an IVF laboratory (staffing and direction, quality management, laboratory safety), and on the specific aspects of the procedures performed in IVF laboratories (Identification of patients and traceability of their reproductive cells, consumables, handling of biological material, oocyte retrieval, sperm preparation, insemination of oocytes, scoring for fertilization, embryo culture and transfer, and cryopreservation). A last section provides recommendations regarding an Emergency plan for IVF laboratories. Evidence on most of the issues described is scarce, and therefore it was decided not to perform a formal search for and assessment of scientific evidence. However, recommendations published in the EUTCD and relevant and recent documents, manuals and consensus papers were taken into account when formulating the recommendations. Despite the limitations, the guideline

  13. Metrology for Fuel Cell Manufacturing

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Stocker, Michael; Stanfield, Eric

    2015-02-04

    The project was divided into three subprojects. The first subproject is Fuel Cell Manufacturing Variability and Its Impact on Performance. The objective was to determine if flow field channel dimensional variability has an impact on fuel cell performance. The second subproject is Non-contact Sensor Evaluation for Bipolar Plate Manufacturing Process Control and Smart Assembly of Fuel Cell Stacks. The objective was to enable cost reduction in the manufacture of fuel cell plates by providing a rapid non-contact measurement system for in-line process control. The third subproject is Optical Scatterfield Metrology for Online Catalyst Coating Inspection of PEM Soft Goods. Themore » objective was to evaluate the suitability of Optical Scatterfield Microscopy as a viable measurement tool for in situ process control of catalyst coatings.« less

  14. Quick Tips Guide for Small Manufacturing Businesses

    EPA Pesticide Factsheets

    Small manufacturing businesses can use this Quick Tips Guide to be better prepared for future extreme weather events. This guide discusses keeping good records, improving housekeeping procedures, and training employees.

  15. [Good practice guidelines for health information].

    PubMed

    2016-01-01

    Evidence-based health information is distinguished by the provision of an unbiased and trustworthy description of the current state of medical knowledge. It enables people to learn more about health and disease, and to make health-related decisions - on their own or together with others - reflecting their attitudes and lifestyle. To adequately serve this purpose, health information must be evidence-based. A working group from the German Network for Evidence-based Medicine (Deutsches Netzwerk Evidenzbasierte Medizin) has developed a first draft of good practice guidelines for health information (Gute Praxis Gesundheitsinformation) with the aim of providing support for authors and publishers of evidence-based health information. The group included researchers, patient representatives, journalists and developers of health information. The criteria for evidence-based health information were developed and agreed upon within this author group, and then made available for public comment. All submitted comments were documented and assessed regarding the need to revise or amend the draft. Changes were subsequently implemented following approval by the author group. Gute Praxis Gesundheitsinformation calls for a transparent methodological approach in the development of health information. To achieve this, evidence-based information must be based on (a) a systematic literature search, (b) a justified selection of evidence, (c) unbiased reporting of relevant results, (d) appropriate factual and linguistic communication of uncertainties, (e) either avoidance of any direct recommendations or a strict division between the reporting of results and the derivation of recommendations, (f) the consideration of current evidence on the communication of figures, risks and probabilities, and (g) transparent information about the authors and publishers of the health information, including their funding sources. Gute Praxis Gesundheitsinformation lists a total of 16 aspects to be addressed

  16. 77 FR 16158 - Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-20

    ... ``cut'' from a sheet or roll of labels--is used. Persistent problems with drug product mislabeling and... believe that development and use of advanced code scanning equipment has made many current electronic... and other advanced scanning techniques have made current electronic systems reliable to the 100...

  17. Clinician-Reported Outcome Assessments of Treatment Benefit: Report of the ISPOR Clinical Outcome Assessment Emerging Good Practices Task Force

    PubMed Central

    Powers, John H.; Patrick, Donald L.; Walton, Marc K.; Marquis, Patrick; Cano, Stefan; Hobart, Jeremy; Isaac, Maria; Vamvakas, Spiros; Slagle, Ashley; Molsen, Elizabeth; Burke, Laurie B.

    2017-01-01

    A clinician-reported outcome (ClinRO) assessment is a type of clinical outcome assessment (COA). ClinRO assessments, like all COAs (patient-reported, observer-reported, or performance outcome assessments), are used to 1) measure patients’ health status and 2) define end points that can be interpreted as treatment benefits of medical interventions on how patients feel, function, or survive in clinical trials. Like other COAs, ClinRO assessments can be influenced by human choices, judgment, or motivation. A ClinRO assessment is conducted and reported by a trained health care professional and requires specialized professional training to evaluate the patient’s health status. This is the second of two reports by the ISPOR Clinical Outcomes Assessment—Emerging Good Practices for Outcomes Research Task Force. The first report provided an overview of COAs including definitions important for an understanding of COA measurement practices. This report focuses specifically on issues related to ClinRO assessments. In this report, we define three types of ClinRO assessments (readings, ratings, and clinician global assessments) and describe emerging good measurement practices in their development and evaluation. The good measurement practices include 1) defining the context of use; 2) identifying the concept of interest measured; 3) defining the intended treatment benefit on how patients feel, function, or survive reflected by the ClinRO assessment and evaluating the relationship between that intended treatment benefit and the concept of interest; 4) documenting content validity; 5) evaluating other measurement properties once content validity is established (including intra- and inter-rater reliability); 6) defining study objectives and end point(s) objectives, and defining study end points and placing study end points within the hierarchy of end points; 7) establishing interpretability in trial results; and 8) evaluating operational considerations for the implementation

  18. Long-term quality assurance of [(18)F]-fluorodeoxyglucose (FDG) manufacturing.

    PubMed

    Gaspar, Ludovit; Reich, Michal; Kassai, Zoltan; Macasek, Fedor; Rodrigo, Luis; Kruzliak, Peter; Kovac, Peter

    2016-01-01

    Nine years of experience with 2286 commercial synthesis allowed us to deliver comprehensive information on the quality of (18)F-FDG production. Semi-automated FDG production line using Cyclone 18/9 machine (IBA Belgium), TRACERLab MXFDG synthesiser (GE Health, USA) using alkalic hydrolysis, grade "A" isolator with dispensing robotic unit (Tema Sinergie, Italy), and automatic control system under GAMP5 (minus2, Slovakia) was assessed by TQM tools as highly reliable aseptic production line, fully compliant with Good Manufacturing Practice and just-in-time delivery of FDG radiopharmaceutical. Fluoride-18 is received in steady yield and of very high radioactive purity. Synthesis yields exhibited high variance connected probably with quality of disposable cassettes and chemicals sets. Most performance non-conformities within the manufacturing cycle occur at mechanical nodes of dispensing unit. The long-term monitoring of 2286 commercial synthesis indicated high reliability of automatic synthesizers. Shewhart chart and ANOVA analysis showed that minor non-compliances occurred were mostly caused by the declinations of less experienced staff from standard operation procedures, and also by quality of automatic cassettes. Only 15 syntheses were found unfinished and in 4 cases the product was out-of-specification of European Pharmacopoeia. Most vulnerable step of manufacturing was dispensing and filling in grade "A" isolator. Its cleanliness and sterility was fully controlled under the investigated period by applying hydrogen peroxide vapours (VHP). Our experience with quality assurance in the production of [(18)F]-fluorodeoxyglucose (FDG) at production facility of BIONT based on TRACERlab MXFDG production module can be used for bench-marking of the emerging manufacturing and automated manufacturing systems.

  19. Long-term quality assurance of [18F]-fluorodeoxyglucose (FDG) manufacturing

    PubMed Central

    Gaspar, Ludovit; Reich, Michal; Kassai, Zoltan; Macasek, Fedor; Rodrigo, Luis; Kruzliak, Peter; Kovac, Peter

    2016-01-01

    Nine years of experience with 2286 commercial synthesis allowed us to deliver comprehensive information on the quality of 18F-FDG production. Semi-automated FDG production line using Cyclone 18/9 machine (IBA Belgium), TRACERLab MXFDG synthesiser (GE Health, USA) using alkalic hydrolysis, grade “A” isolator with dispensing robotic unit (Tema Sinergie, Italy), and automatic control system under GAMP5 (minus2, Slovakia) was assessed by TQM tools as highly reliable aseptic production line, fully compliant with Good Manufacturing Practice and just-in-time delivery of FDG radiopharmaceutical. Fluoride-18 is received in steady yield and of very high radioactive purity. Synthesis yields exhibited high variance connected probably with quality of disposable cassettes and chemicals sets. Most performance non-conformities within the manufacturing cycle occur at mechanical nodes of dispensing unit. The long-term monitoring of 2286 commercial synthesis indicated high reliability of automatic synthesizers. Shewhart chart and ANOVA analysis showed that minor non-compliances occurred were mostly caused by the declinations of less experienced staff from standard operation procedures, and also by quality of automatic cassettes. Only 15 syntheses were found unfinished and in 4 cases the product was out-of-specification of European Pharmacopoeia. Most vulnerable step of manufacturing was dispensing and filling in grade “A” isolator. Its cleanliness and sterility was fully controlled under the investigated period by applying hydrogen peroxide vapours (VHP). Our experience with quality assurance in the production of [18F]-fluorodeoxyglucose (FDG) at production facility of BIONT based on TRACERlab MXFDG production module can be used for bench-marking of the emerging manufacturing and automated manufacturing systems. PMID:27508102

  20. Good research practices for measuring drug costs in cost-effectiveness analyses: a societal perspective: the ISPOR Drug Cost Task Force report--Part II.

    PubMed

    Garrison, Louis P; Mansley, Edward C; Abbott, Thomas A; Bresnahan, Brian W; Hay, Joel W; Smeeding, James

    2010-01-01

    Major guidelines regarding the application of cost-effectiveness analysis (CEA) have recommended the common and widespread use of the "societal perspective" for purposes of consistency and comparability. The objective of this Task Force subgroup report (one of six reports from the International Society for Pharmacoeconomics and Outcomes Research [ISPOR] Task Force on Good Research Practices-Use of Drug Costs for Cost Effectiveness Analysis [Drug Cost Task Force (DCTF)]) was to review the definition of this perspective, assess its specific application in measuring drug costs, identify any limitations in theory or practice, and make recommendations regarding potential improvements. Key articles, books, and reports in the methodological literature were reviewed, summarized, and integrated into a draft review and report. This draft report was posted for review and comment by ISPOR membership. Numerous comments and suggestions were received, and the report was revised in response to them. The societal perspective can be defined by three conditions: 1) the inclusion of time costs, 2) the use of opportunity costs, and 3) the use of community preferences. In practice, very few, if any, published CEAs have met all of these conditions, though many claim to have taken a societal perspective. Branded drug costs have typically used actual acquisition cost rather than the much lower social opportunity costs that would reflect only short-run manufacturing and distribution costs. This practice is understandable, pragmatic, and useful to current decision-makers. Nevertheless, this use of CEA focuses on static rather than dynamic efficacy and overlooks the related incentives for innovation. Our key recommendation is that current CEA practice acknowledge and embrace this limitation by adopting a new standard for the reference case as one of a "limited societal" or "health systems" perspective, using acquisition drug prices while including indirect costs and community preferences. The

  1. Pay for performance of Estonian family doctors and impact of different practice- and patient-related characteristics on a good outcome: A quantitative assessment.

    PubMed

    Merilind, Eero; Salupere, Rauno; Västra, Katrin; Kalda, Ruth

    2016-01-01

    Several practice- and patient-related characteristics are reported to have an influence on a good quality outcome. Estonia started the pay-for-performance (P4P) system for family doctors (FDs) in 2006. Every year the number of FDs participating in P4P has increased, but only half of the FDs achieved good outcome. The aim of this study was to find out which practice- and patient-related characteristics could have an impact on a good outcome. The study was conducted using the database from the Estonian Health Insurance Fund. All working FDs were divided into two groups (with "good" and "poor" outcomes) according their achievements in P4P. We chose characteristics which described structure (practice list size, number of doctors, composition of FDs list: age, number of chronically ill patients) during the observation period 2006-2012. During the observation period 2006-2012, the number of FDs with a good outcome in P4P increased from 6% (2006) to 53% (2012). The high number of FDs in primary care teams, longer experience of participation in P4P and the smaller number of patients on FDs' lists all have an impact on a good outcome. The number of chronically ill patients in FDs lists has no significant effect on an outcome, but P4P increases the number of disease-diagnosed patients. Different practice and patient-related characteristics have an impact on a good outcome. As workload increases, smaller lists of FDs patients or increased staff levels are needed in order to maintain a good outcome. Copyright © 2016 The Lithuanian University of Health Sciences. Production and hosting by Elsevier Urban & Partner Sp. z o.o. All rights reserved.

  2. Achieving Consensus on Principles of Good Practice for School Health in Independent Schools: A Delphi Study

    ERIC Educational Resources Information Center

    Marshall, Miguel G.; Allegrante, John P.

    2017-01-01

    Background: Although the 8 components of the coordinated school health (CSH) framework have been implemented to various degrees in the nation's public schools, principles of good practice (PGPs) to guide health promotion efforts in independent schools do not exist. The purpose of this study was to generate PGPs and rate their feasibility of…

  3. A checklist for health research priority setting: nine common themes of good practice.

    PubMed

    Viergever, Roderik F; Olifson, Sylvie; Ghaffar, Abdul; Terry, Robert F

    2010-12-15

    Health research priority setting processes assist researchers and policymakers in effectively targeting research that has the greatest potential public health benefit. Many different approaches to health research prioritization exist, but there is no agreement on what might constitute best practice. Moreover, because of the many different contexts for which priorities can be set, attempting to produce one best practice is in fact not appropriate, as the optimal approach varies per exercise. Therefore, following a literature review and an analysis of health research priority setting exercises that were organized or coordinated by the World Health Organization since 2005, we propose a checklist for health research priority setting that allows for informed choices on different approaches and outlines nine common themes of good practice. It is intended to provide generic assistance for planning health research prioritization processes. The checklist explains what needs to be clarified in order to establish the context for which priorities are set; it reviews available approaches to health research priority setting; it offers discussions on stakeholder participation and information gathering; it sets out options for use of criteria and different methods for deciding upon priorities; and it emphasizes the importance of well-planned implementation, evaluation and transparency.

  4. Harmonization of good laboratory practice requirements and laboratory accreditation programs.

    PubMed

    Royal, P D

    1994-09-01

    Efforts to harmonize Good Laboratory Practice (GLP) requirements have been underway through the Organization for Economic Cooperation and Development (OECD) since 1981. In 1985, a GLP panel was established to facilitate the practical implementation of the OECD/GLP program. Through the OECD/GLP program, Memoranda of Understanding (MOU) agreements which foster requirements for reciprocal data and study acceptance and unified GLP standards have been developed among member countries. Three OECD Consensus Workshops and three inspectors training workshops have been held. In concert with these efforts, several OECD countries have developed GLP accreditation programs, managed by local health and environmental ministries. In addition, Canada and the United States are investigating Laboratory Accreditation programs for environmental monitoring assessment and GLP-regulated studies. In the European Community (EC), the need for quality standards specifying requirements for production and international trade has promoted International Standards Organization (ISO) certification for certain products. ISO-9000 standards identify requirements for certification of quality systems. These certification programs may affect the trade and market of laboratories conducting GLP studies. Two goals identified by these efforts are common to both programs: first, harmonization and recognition of requirements, and second, confidence in the rigor of program components used to assess the integrity of data produced and study activities. This confidence can be promoted, in part, through laboratory inspection and screening processes. However, the question remains, will data produced by sanctioned laboratories be mutually accepted on an international basis?(ABSTRACT TRUNCATED AT 250 WORDS)

  5. 12 CFR 308.7 - Good faith certification.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 12 Banks and Banking 5 2014-01-01 2014-01-01 false Good faith certification. 308.7 Section 308.7... PRACTICE AND PROCEDURE Uniform Rules of Practice and Procedure § 308.7 Good faith certification. (a... in fact and is warranted by existing law or a good faith argument for the extension, modification, or...

  6. 12 CFR 263.7 - Good faith certification.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 12 Banks and Banking 4 2014-01-01 2014-01-01 false Good faith certification. 263.7 Section 263.7... (CONTINUED) RULES OF PRACTICE FOR HEARINGS Uniform Rules of Practice and Procedure § 263.7 Good faith... in fact and is warranted by existing law or a good faith argument for the extension, modification, or...

  7. 12 CFR 263.7 - Good faith certification.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 12 Banks and Banking 3 2011-01-01 2011-01-01 false Good faith certification. 263.7 Section 263.7... RULES OF PRACTICE FOR HEARINGS Uniform Rules of Practice and Procedure § 263.7 Good faith certification... in fact and is warranted by existing law or a good faith argument for the extension, modification, or...

  8. 12 CFR 263.7 - Good faith certification.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 12 Banks and Banking 4 2013-01-01 2013-01-01 false Good faith certification. 263.7 Section 263.7... (CONTINUED) RULES OF PRACTICE FOR HEARINGS Uniform Rules of Practice and Procedure § 263.7 Good faith... in fact and is warranted by existing law or a good faith argument for the extension, modification, or...

  9. 12 CFR 308.7 - Good faith certification.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 12 Banks and Banking 5 2012-01-01 2012-01-01 false Good faith certification. 308.7 Section 308.7... PRACTICE AND PROCEDURE Uniform Rules of Practice and Procedure § 308.7 Good faith certification. (a... in fact and is warranted by existing law or a good faith argument for the extension, modification, or...

  10. 12 CFR 263.7 - Good faith certification.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 12 Banks and Banking 4 2012-01-01 2012-01-01 false Good faith certification. 263.7 Section 263.7... (CONTINUED) RULES OF PRACTICE FOR HEARINGS Uniform Rules of Practice and Procedure § 263.7 Good faith... in fact and is warranted by existing law or a good faith argument for the extension, modification, or...

  11. 12 CFR 308.7 - Good faith certification.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 12 Banks and Banking 5 2013-01-01 2013-01-01 false Good faith certification. 308.7 Section 308.7... PRACTICE AND PROCEDURE Uniform Rules of Practice and Procedure § 308.7 Good faith certification. (a... in fact and is warranted by existing law or a good faith argument for the extension, modification, or...

  12. 12 CFR 308.7 - Good faith certification.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 12 Banks and Banking 4 2011-01-01 2011-01-01 false Good faith certification. 308.7 Section 308.7... PRACTICE AND PROCEDURE Uniform Rules of Practice and Procedure § 308.7 Good faith certification. (a... in fact and is warranted by existing law or a good faith argument for the extension, modification, or...

  13. 12 CFR 308.7 - Good faith certification.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 12 Banks and Banking 4 2010-01-01 2010-01-01 false Good faith certification. 308.7 Section 308.7... PRACTICE AND PROCEDURE Uniform Rules of Practice and Procedure § 308.7 Good faith certification. (a... in fact and is warranted by existing law or a good faith argument for the extension, modification, or...

  14. 12 CFR 263.7 - Good faith certification.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 12 Banks and Banking 3 2010-01-01 2010-01-01 false Good faith certification. 263.7 Section 263.7... RULES OF PRACTICE FOR HEARINGS Uniform Rules of Practice and Procedure § 263.7 Good faith certification... in fact and is warranted by existing law or a good faith argument for the extension, modification, or...

  15. A Cross-Disciplinary Partnership to Improve Manufacturing Education.

    ERIC Educational Resources Information Center

    Stephens, Matthew P.; Kraebber, Henry W.

    1998-01-01

    An exemplary university/business partnership involved the development of a training program to enhance workplace productivity for a relatively small manufacturing facility. The objectives were to educate the work force in the principles of workplace organization and lean manufacturing practices. (Author/JOW)

  16. IT-supported integrated care pathways for diabetes: A compilation and review of good practices.

    PubMed

    Vrijhoef, Hubertus Jm; de Belvis, Antonio Giulio; de la Calle, Matias; de Sabata, Maria Stella; Hauck, Bastian; Montante, Sabrina; Moritz, Annette; Pelizzola, Dario; Saraheimo, Markku; Guldemond, Nick A

    2017-06-01

    Integrated Care Pathways (ICPs) are a method for the mutual decision-making and organization of care for a well-defined group of patients during a well-defined period. The aim of a care pathway is to enhance the quality of care by improving patient outcomes, promoting patient safety, increasing patient satisfaction, and optimizing the use of resources. To describe this concept, different names are used, e.g. care pathways and integrated care pathways. Modern information technologies (IT) can support ICPs by enabling patient empowerment, better management, and the monitoring of care provided by multidisciplinary teams. This study analyses ICPs across Europe, identifying commonalities and success factors to establish good practices for IT-supported ICPs in diabetes care. A mixed-method approach was applied, combining desk research on 24 projects from the European Innovation Partnership on Active and Healthy Ageing (EIP on AHA) with follow-up interviews of project participants, and a non-systematic literature review. We applied a Delphi technique to select process and outcome indicators, derived from different literature sources which were compiled and applied for the identification of successful good practices. Desk research identified sixteen projects featuring IT-supported ICPs, mostly derived from the EIP on AHA, as good practices based on our criteria. Follow-up interviews were then conducted with representatives from 9 of the 16 projects to gather information not publicly available and understand how these projects were meeting the identified criteria. In parallel, the non-systematic literature review of 434 PubMed search results revealed a total of eight relevant projects. On the basis of the selected EIP on AHA project data and non-systematic literature review, no commonalities with regard to defined process or outcome indicators could be identified through our approach. Conversely, the research produced a heterogeneous picture in all aspects of the projects

  17. Practice‐based Research Network Research Good Practices (PRGPs): Summary of Recommendations

    PubMed Central

    Campbell‐Voytal, Kimberly; Daly, Jeanette; Nagykaldi, Zsolt J.; O'Beirne, Maeve; Sterling, Pamela; Fagnan, Lyle J.; Levy, Barcey; Michaels, LeAnn; Louks, Hannah A.; Smith, Paul; Aspy, Cheryl B.; Patterson, V. Beth; Kano, Miria; Sussman, Andrew L.; Williams, Robert; Neale, Anne Victoria

    2015-01-01

    Abstract Introduction Practice‐based research networks (PBRNs) conduct research in community settings, which poses quality control challenges to the integrity of research, such as study implementation and data collection. A foundation for improving research processes within PBRNs is needed to ensure research integrity. Methods Network directors and coordinators from seven U.S.‐based PBRNs worked with a professional team facilitator during semiannual in‐person meetings and monthly conference calls to produce content for a compendium of recommended research practices specific to the context of PBRNs. Participants were assigned to contribute content congruent with their expertise. Feedback on the draft document was obtained from attendees at the preconference workshop at the annual PBRN meeting in 2013. A revised document was circulated to additional PBRN peers prior to finalization. Results The PBRN Research Good Practices (PRGPs) document is organized into four chapters: (1) Building PBRN Infrastructure; (2) Study Development and Implementation; (3) Data Management, and (4) Dissemination Policies. Each chapter contains an introduction, detailed procedures for each section, and example resources with information links. Conclusion The PRGPs is a PBRN‐specific resource to facilitate PBRN management and staff training, to promote adherence to study protocols, and to increase validity and generalizability of study findings. PMID:26296309

  18. The Future of Additive Manufacturing in the U.S. Military

    DTIC Science & Technology

    2017-03-17

    Manufacturing Prior to the Industrial Revolution, manufacturing simply meant creating products or goods by hand.1 Indeed, the Latin derivation of the word...producing technologies such as the water wheel. These new mechanical designs reliably outpaced work done by hand, vastly increased production , and thereby...the realm of textile manufacturing . At the start of the 18th century, the process of thread spinning limited the overall production capacity of the

  19. Laboratory considerations of United States Pharmacopeia Chapter <71> sterility tests and its application to pharmaceutical compounding.

    PubMed

    Hyde, Tiffany D

    2014-01-01

    The purpose of this article is to describe United States Pharmacopeia Chapter <71> Sterility Tests from the perspective of Current Good Manufacturing Practices in order to aid compounding pharmacists in understanding the details and complexities that are required. Compounding pharmacists face a unique challenge in the industry today, with their compounding practice and the U.S. Food and Drug Administration trying to impose Current Good Manufacturing Practices guidelines. Naturally, this becomes a challenge to contract testing laboratories as well, as they are caught between the testing for non-Current Good Manufacturing Practices compounding standards and Current Good Manufacturing Practices manufacturing. It is important that the compounding pharmacist and their partner testing laboratory work closely together to ensure appropriate requirements are being met.

  20. 29 CFR 779.348 - Goods must be made at the establishment which sells them.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... not be exempt. The latter is a manufacturing establishment. For example, a candy kitchen manufacturing candy for sale at separate retail outlets is a manufacturing establishment and not a retail... goods for sale to customers who will go to other places to buy them. Thus an establishment that makes or...