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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...

  2. 21 CFR 110.5 - 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. 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...

  3. 21 CFR 110.5 - 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. 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...

  4. 21 CFR 110.5 - 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. 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...

  5. 21 CFR 110.5 - 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. 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...

  6. 21 CFR 225.1 - Current good manufacturing practice.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 4 2011-04-01 2011-04-01 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...

  7. 21 CFR 225.1 - Current good manufacturing practice.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 4 2013-04-01 2013-04-01 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...

  8. 21 CFR 226.1 - Current good manufacturing practice.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 4 2011-04-01 2011-04-01 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,...

  9. 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...

  10. 21 CFR 225.1 - Current good manufacturing practice.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 4 2012-04-01 2012-04-01 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...

  11. 21 CFR 225.1 - Current good manufacturing practice.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 4 2014-04-01 2014-04-01 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...

  12. 21 CFR 226.1 - Current good manufacturing practice.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 4 2014-04-01 2014-04-01 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,...

  13. 21 CFR 226.1 - Current good manufacturing practice.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 4 2013-04-01 2013-04-01 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,...

  14. 21 CFR 226.1 - Current good manufacturing practice.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 4 2012-04-01 2012-04-01 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,...

  15. 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,...

  16. 21 CFR 129.1 - 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. 129.1 Section... Current good manufacturing practice. The applicable criteria in part 110 of this chapter, as well as the... manufacturing practice to assure that bottled drinking water is safe and that it has been processed,...

  17. 21 CFR 129.1 - 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. 129.1 Section... Current good manufacturing practice. The applicable criteria in part 110 of this chapter, as well as the... manufacturing practice to assure that bottled drinking water is safe and that it has been processed,...

  18. 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... manufacturing practice to assure that bottled drinking water is safe and that it has been processed,...

  19. 21 CFR 129.1 - 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. 129.1 Section... Current good manufacturing practice. The applicable criteria in part 110 of this chapter, as well as the... manufacturing practice to assure that bottled drinking water is safe and that it has been processed,...

  20. 21 CFR 129.1 - 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. 129.1 Section... Current good manufacturing practice. The applicable criteria in part 110 of this chapter, as well as the... manufacturing practice to assure that bottled drinking water is safe and that it has been processed,...

  1. 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... Provisions § 120.5 Current good manufacturing practice. Part 110 of this chapter applies in...

  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... CONTAINERS General Provisions § 113.5 Current good manufacturing practice. The criteria in §§ 113.10,...

  3. 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... Provisions § 120.5 Current good manufacturing practice. Part 110 of this chapter applies in...

  4. 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... Provisions § 120.5 Current good manufacturing practice. Part 110 of this chapter applies in...

  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... Provisions § 120.5 Current good manufacturing practice. Part 110 of this chapter applies in...

  6. 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 113.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... CONTAINERS General Provisions § 113.5 Current good manufacturing practice. The criteria in §§ 113.10,...

  7. 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... Provisions § 120.5 Current good manufacturing practice. Part 110 of this chapter applies in...

  8. 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... CONTAINERS General Provisions § 113.5 Current good manufacturing practice. The criteria in §§ 113.10,...

  9. 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... CONTAINERS General Provisions § 113.5 Current good manufacturing practice. The criteria in §§ 113.10,...

  10. 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... CONTAINERS General Provisions § 113.5 Current good manufacturing practice. The criteria in §§ 113.10,...

  11. A summarized discussion of current good manufacturing practice regulations.

    PubMed

    Allen, Loyd V

    2013-01-01

    In light of recent events and discussions of compounding pharmacy, it is important to discuss and understand the purpose of good manufacturing practices. This article provides a summary of the current Good Manufacturing Practice Regulations which were established by the U.S. Food and Drug Administration. PMID:24046937

  12. A summarized discussion of current good manufacturing practice regulations.

    PubMed

    Allen, Loyd V

    2013-01-01

    In light of recent events and discussions of compounding pharmacy, it is important to discuss and understand the purpose of good manufacturing practices. This article provides a summary of the current Good Manufacturing Practice Regulations which were established by the U.S. Food and Drug Administration.

  13. Good manufacturing practice production of adenoviral vectors for clinical trials.

    PubMed

    Lusky, Monika

    2005-03-01

    The increasing importance of recombinant adenoviral vectors for gene therapy, cancer therapy, and the development of prophylactic and therapeutic vaccines has led to worldwide efforts toward scalable process development suitable for commercial manufacturing of replication-deficient adenoviral vectors. This review focuses on the manufacturing of adenovirus for clinical trials in the context of good manufacturing practice conditions and regulations. PMID:15812223

  14. 21 CFR 123.5 - 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. 123.5 Section 123.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... manufacturing practice. (a) Part 110 of this chapter applies in determining whether the facilities,...

  15. 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 123.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... manufacturing practice. (a) Part 110 of this chapter applies in determining whether the facilities,...

  16. 21 CFR 123.5 - 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. 123.5 Section 123.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... manufacturing practice. (a) Part 110 of this chapter applies in determining whether the facilities,...

  17. 21 CFR 123.5 - 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. 123.5 Section 123.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... manufacturing practice. (a) Part 110 of this chapter applies in determining whether the facilities,...

  18. 21 CFR 123.5 - 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. 123.5 Section 123.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... manufacturing practice. (a) Part 110 of this chapter applies in determining whether the facilities,...

  19. 21 CFR 114.5 - 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. 114.5 Section 114.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION ACIDIFIED FOODS General Provisions § 114.5 Current good...

  20. 21 CFR 114.5 - 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. 114.5 Section 114.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION ACIDIFIED FOODS General Provisions § 114.5 Current good...

  1. 21 CFR 114.5 - 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. 114.5 Section 114.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION ACIDIFIED FOODS General Provisions § 114.5 Current good...

  2. 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 114.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION ACIDIFIED FOODS General Provisions § 114.5 Current good...

  3. 21 CFR 114.5 - 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. 114.5 Section 114.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION ACIDIFIED FOODS General Provisions § 114.5 Current good...

  4. 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

    ... Manufacturing Practice for Positron Emission Tomography Drugs; Availability AGENCY: Food and Drug Administration... a guidance for small business entities entitled ``PET Drugs--Current Good Manufacturing Practice... entitled ``PET Drugs--Current Good Manufacturing Practice (CGMP); Small Entity Compliance Guide.''...

  5. 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.

  6. 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

  7. 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. PMID:25883511

  8. 78 FR 12068 - Device Good Manufacturing Practice Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-21

    ... HUMAN SERVICES Food and Drug Administration Device Good Manufacturing Practice Advisory Committee... meeting will be open to the public. Name of Committee: Device Good Manufacturing Practice Advisory... effects of extreme weather and natural disasters on medical device manufacturing chain processes...

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

    SciTech Connect

    Iveson, Steven W.

    2014-11-01

    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 are 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.

  10. Good manufacturing practices production of mesenchymal stem/stromal cells.

    PubMed

    Sensebé, Luc; Bourin, Philippe; Tarte, Karin

    2011-01-01

    Because of their multi/pluripotency and immunosuppressive properties mesenchymal stem/stromal cells (MSCs) are important tools for treating immune disorders and for tissue repair. The increasing use of MSCs has led to production processes that need to be in accordance with Good Manufacturing Practice (GMP). In cellular therapy, safety remains one of the main concerns and refers to donor validation, choice of starting material, processes, and the controls used, not only at the batch release level but also during the development of processes. The culture processes should be reproducible, robust, and efficient. Moreover, they should be adapted to closed systems that are easy to use. Implementing controls during the manufacturing of clinical-grade MSCs is essential. The controls should ensure microbiological safety but also avoid potential side effects linked to genomic instability driving transformation and senescence or decrease of cell functions (immunoregulation, differentiation potential). In this rapidly evolving field, a new approach to controls is needed.

  11. 21 CFR 210.1 - Status of current good manufacturing practice regulations.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 4 2012-04-01 2012-04-01 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...

  12. 21 CFR 210.1 - Status of current good manufacturing practice regulations.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 4 2014-04-01 2014-04-01 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...

  13. 21 CFR 210.1 - Status 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 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...

  14. 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...

  15. 21 CFR 210.1 - Status of current good manufacturing practice regulations.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 4 2013-04-01 2013-04-01 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...

  16. Preparation of intravenous cholesterol tracer using current good manufacturing practices.

    PubMed

    Lin, Xiaobo; Ma, Lina; Racette, Susan B; Swaney, William P; Ostlund, Richard E

    2015-12-01

    Studies of human reverse cholesterol transport require intravenous infusion of cholesterol tracers. Because insoluble lipids may pose risk and because it is desirable to have consistent doses of defined composition available over many months, we investigated the manufacture of cholesterol tracer under current good manufacturing practice (CGMP) conditions appropriate for phase 1 investigation. Cholesterol tracer was prepared by sterile admixture of unlabeled cholesterol or cholesterol-d7 in ethanol with 20% Intralipid(®). The resulting material was filtered through a 1.2 micron particulate filter, stored at 4°C, and tested at time 0, 1.5, 3, 6, and 9 months for sterility, pyrogenicity, autoxidation, and particle size and aggregation. The limiting factor for stability was a rise in thiobarbituric acid-reacting substances of 9.6-fold over 9 months (P < 0.01). The emulsion was stable with the Z-average intensity-weighted mean droplet diameter remaining at 60 nm over 23 months. The zeta potential (a measure of negative surface charge protecting from aggregation) was unchanged at -36.2. Rapid cholesterol pool size was 25.3 ± 1.3 g. Intravenous cholesterol tracer was stable at 4°C for 9 months postproduction. CGMP manufacturing methods can be achieved in the academic setting and need to be considered for critical components of future metabolic studies.

  17. Preparation of intravenous cholesterol tracer using current good manufacturing practices.

    PubMed

    Lin, Xiaobo; Ma, Lina; Racette, Susan B; Swaney, William P; Ostlund, Richard E

    2015-12-01

    Studies of human reverse cholesterol transport require intravenous infusion of cholesterol tracers. Because insoluble lipids may pose risk and because it is desirable to have consistent doses of defined composition available over many months, we investigated the manufacture of cholesterol tracer under current good manufacturing practice (CGMP) conditions appropriate for phase 1 investigation. Cholesterol tracer was prepared by sterile admixture of unlabeled cholesterol or cholesterol-d7 in ethanol with 20% Intralipid(®). The resulting material was filtered through a 1.2 micron particulate filter, stored at 4°C, and tested at time 0, 1.5, 3, 6, and 9 months for sterility, pyrogenicity, autoxidation, and particle size and aggregation. The limiting factor for stability was a rise in thiobarbituric acid-reacting substances of 9.6-fold over 9 months (P < 0.01). The emulsion was stable with the Z-average intensity-weighted mean droplet diameter remaining at 60 nm over 23 months. The zeta potential (a measure of negative surface charge protecting from aggregation) was unchanged at -36.2. Rapid cholesterol pool size was 25.3 ± 1.3 g. Intravenous cholesterol tracer was stable at 4°C for 9 months postproduction. CGMP manufacturing methods can be achieved in the academic setting and need to be considered for critical components of future metabolic studies. PMID:26416797

  18. 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...

  19. 21 CFR 212.2 - What is current good manufacturing practice for PET drugs?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 4 2014-04-01 2014-04-01 false What is current good manufacturing practice for... HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR POSITRON EMISSION TOMOGRAPHY DRUGS General Provisions § 212.2 What is current good manufacturing practice for PET...

  20. 78 FR 4307 - Current Good Manufacturing Practice Requirements for Combination Products

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-22

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Part 4 Current Good Manufacturing Practice... manufacturing practice (CGMP) requirements applicable to combination products. This rule is intended to promote... good manufacturing practice requirements apply to my combination product? (Sec. 4.3) E. How can...

  1. 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...

  2. 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... 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...

  3. 21 CFR 210.2 - Applicability of current good manufacturing practice regulations.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 4 2014-04-01 2014-04-01 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...

  4. 21 CFR 210.2 - Applicability of current good manufacturing practice regulations.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 4 2012-04-01 2012-04-01 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...

  5. 21 CFR 210.2 - Applicability of current good manufacturing practice regulations.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 4 2013-04-01 2013-04-01 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...

  6. Good manufacturing practice: the role of local manufacturers and competent authorities.

    PubMed

    Tomić, Siniša; Filipović Sučić, Anita; Ilić Martinac, Adrijana

    2010-12-01

    In every country, a manufacturer of medicinal products for either human or veterinary use is required to operate in compliance with local legislation. In all EU Member States, legislation is approximated to the effect that they are committed to abide by the same standards. The candidate countries transpose the acquis into their national legislation, including the good manufacturing practice (GMP). Consequently, the local manufacturer is required to strictly comply with GMP and the manufacturing licence, including for medicinal products exclusively intended for export. A vital role is also played by national regulatory authorities, in Croatia by the Agency for Medicinal Products and Medical Devices which issues the manufacturing licence, GMP certificate, and the Certificate of a Pharmaceutical Product (CPP) and conducts laboratory control of products. GMP inspection is carried out by the Pharmaceutical Inspectorate with the Ministry of Health and Social Welfare. Both authorities are responsible only for human medicines. There are legislative issues not yet harmonised with the acquis, but as a country aspiring for the EU membership, Croatia is expected to demonstrate that its industry and competent authorities are able to conform to current requirements and thus fully adhere to the integrated European regulatory network. Hence the importance of strengthening the institutional capacity of the competent authorities, as insufficient resources may have a direct bearing on patients by limiting their access to affordable treatment. PMID:21183434

  7. Good manufacturing practice: the role of local manufacturers and competent authorities.

    PubMed

    Tomić, Siniša; Filipović Sučić, Anita; Ilić Martinac, Adrijana

    2010-12-01

    In every country, a manufacturer of medicinal products for either human or veterinary use is required to operate in compliance with local legislation. In all EU Member States, legislation is approximated to the effect that they are committed to abide by the same standards. The candidate countries transpose the acquis into their national legislation, including the good manufacturing practice (GMP). Consequently, the local manufacturer is required to strictly comply with GMP and the manufacturing licence, including for medicinal products exclusively intended for export. A vital role is also played by national regulatory authorities, in Croatia by the Agency for Medicinal Products and Medical Devices which issues the manufacturing licence, GMP certificate, and the Certificate of a Pharmaceutical Product (CPP) and conducts laboratory control of products. GMP inspection is carried out by the Pharmaceutical Inspectorate with the Ministry of Health and Social Welfare. Both authorities are responsible only for human medicines. There are legislative issues not yet harmonised with the acquis, but as a country aspiring for the EU membership, Croatia is expected to demonstrate that its industry and competent authorities are able to conform to current requirements and thus fully adhere to the integrated European regulatory network. Hence the importance of strengthening the institutional capacity of the competent authorities, as insufficient resources may have a direct bearing on patients by limiting their access to affordable treatment.

  8. 21 CFR 212.2 - What is current good manufacturing practice for PET drugs?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 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...

  9. Good manufacturing practice: manufacturing of a nerve agent antidote nanoparticle suspension.

    PubMed

    Clark, Andrew P-Z; Dixon, Hong; Cantu, Norma L; Cabell, Larry A; McDonough, Joe A

    2013-01-01

    We have established a current good manufacturing practice (GMP) manufacturing process to produce a nanoparticle suspension of 1,1'-methylenebis-4-[(hydroxyimino)methyl]pyridinium dimethanesulfonate (MMB4 DMS) in cottonseed oil (CSO) as a nerve agent antidote for a Phase 1 clinical trial. Bis-pyridinium oximes such as MMB4 were previously developed for emergency treatment of organophosphate nerve agent intoxication. Many of these compounds offer efficacy superior to monopyridinium oximes, but they have poor thermal stability due to hydrolytic cleavage in aqueous solution. We previously developed a nonaqueous nanoparticle suspension to improve the hydrothermal stability, termed Enhanced Formulation (EF). An example of this formulation technology is a suspension of MMB4 DMS nanoparticles in CSO. Due to the profound effect of particle size distribution on product quality and performance, particle size must be controlled during the manufacturing process. Therefore, a particle size analysis method for MMB4 DMS in CSO was developed and validated to use in support of good laboratory practice/GMP development and production activities. Manufacturing of EF was accomplished by milling MMB4 DMS with CSO and zirconia beads in an agitator bead mill. The resulting bulk material was filled into 5-mL glass vials at a sterile fill facility and terminally sterilized by gamma irradiation. The clinical lot was tested and released, a Certificate of Analysis was issued, and a 3-year International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) stability study started. The drug product was placed in storage for Phase 1 clinical trial distribution. A dose delivery uniformity study was undertaken to ensure that the correct doses were delivered to the patients in the clinic. PMID:23929446

  10. Good manufacturing practice: manufacturing of a nerve agent antidote nanoparticle suspension.

    PubMed

    Clark, Andrew P-Z; Dixon, Hong; Cantu, Norma L; Cabell, Larry A; McDonough, Joe A

    2013-01-01

    We have established a current good manufacturing practice (GMP) manufacturing process to produce a nanoparticle suspension of 1,1'-methylenebis-4-[(hydroxyimino)methyl]pyridinium dimethanesulfonate (MMB4 DMS) in cottonseed oil (CSO) as a nerve agent antidote for a Phase 1 clinical trial. Bis-pyridinium oximes such as MMB4 were previously developed for emergency treatment of organophosphate nerve agent intoxication. Many of these compounds offer efficacy superior to monopyridinium oximes, but they have poor thermal stability due to hydrolytic cleavage in aqueous solution. We previously developed a nonaqueous nanoparticle suspension to improve the hydrothermal stability, termed Enhanced Formulation (EF). An example of this formulation technology is a suspension of MMB4 DMS nanoparticles in CSO. Due to the profound effect of particle size distribution on product quality and performance, particle size must be controlled during the manufacturing process. Therefore, a particle size analysis method for MMB4 DMS in CSO was developed and validated to use in support of good laboratory practice/GMP development and production activities. Manufacturing of EF was accomplished by milling MMB4 DMS with CSO and zirconia beads in an agitator bead mill. The resulting bulk material was filled into 5-mL glass vials at a sterile fill facility and terminally sterilized by gamma irradiation. The clinical lot was tested and released, a Certificate of Analysis was issued, and a 3-year International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) stability study started. The drug product was placed in storage for Phase 1 clinical trial distribution. A dose delivery uniformity study was undertaken to ensure that the correct doses were delivered to the patients in the clinic.

  11. Proposed rule: current good manufacturing practice in manufacturing, packing, or holding dietary ingredients and dietary supplements.

    PubMed

    Melethil, Srikumaran

    2006-03-27

    The Dietary Supplement Health and Education Act (DSHEA) was enacted in October 1994 to promote the health of Americans by ensuring easier access to safe dietary supplements. Many supplements such as vitamins, minerals, herbs and amino acids have been reported to be helpful in chronic conditions (i.e., heart disease, cancer and osteoporosis). Under DSHEA, dietary supplements can be marketed without prior FDA approval; the burden is on this agency to show that a marketed dietary supplement is unsafe. However, DSHEA retained the FDA's authority to issue regulations that require the manufacture of dietary supplements be in compliance with current good manufacturing practice (cGMP) standards, which are needed to ensure their quality. Several quality-related concerns of marketed dietary supplements that came to light since the passage of DSHEA prompted the FDA in 2003 to propose rules for cGMP for the manufacture, packaging and holding (storage) of dietary supplements. This review will present the highlights of these proposed rules, focusing on the legislative history of DSHEA, rationale for proposing cGMPs along with a general discussion of the specific requirements. Given the voluminous nature of the specific details, the reader is directed to the pertinent FDA publications for details. In this analysis, selected scientific and legal issues are also discussed to promote a better understanding and implications of these rules.

  12. 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

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

    PubMed

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

    2015-01-01

    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.

  14. 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. PMID:25096172

  15. 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.

  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

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Part 211 (formerly 97N-0300) Current Good... Controls AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug... shape, that physically prevents incorrect labeling from being processed by labeling and...

  17. 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.

  18. 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

    ..., and 211 RIN 0910-AG36 Current Good Manufacturing Practice and Hazard Analysis and Risk- Based... period for the information collection related to the proposed rule on ``Current Good Manufacturing... information collection provisions that are subject to review by the Office of Management and Budget...

  19. The value of Good Manufacturing Practice to a Blood Service in managing the delivery of quality.

    PubMed

    Slopecki, A; Smith, K; Moore, S

    2007-04-01

    The delivery of 'quality' in transfusion medicine is addressed by considering how safe and efficacious blood, blood components, reagents, and services can be provided through the application of an effective quality assurance management system. The creation of such a system in the UK is reviewed through the development of the UK Guide to Good Pharmaceutical Manufacturing Practice from 1971 to the present. It provides simple practical guidance and standards. The UK experience shows how quality assurance has evolved, it is not offered as a model to be followed. The UK approach merged with that of the European Union from the early 1990s. The use of such a quality management system to support the application of licensing and accreditation standards relevant to the work of a modern Blood Service is considered, as are processes to learn about the effective and efficacious use of blood and blood components.

  20. A goat's head on a sheep's body? Manufacturing good practices for Tibetan medicine.

    PubMed

    Saxer, Martin

    2012-01-01

    The production of Tibetan pharmaceuticals underwent a far-reaching transformation over the past decade. The introduction of good manufacturing practices (GMP) marked the beginning of rapid industrialization: new factories were built, and the companies re-oriented themselves to the requirements of the market. While officially regarded a great success, many doctors and pharmacists see GMP as fundamentally incompatible with traditional production methods and notions of quality. In this article, I address this incompatibility and examine where and how it affects the actual practice of producing medicines. While the problem exists, I argue that it does not stem from conflicting epistemologies but rather from the side effects of a quick and forced implementation, which often contradicts the spirit and letter of the regulations themselves. The case sheds new light on the way in which ideas about quality and safety, forged in the global arena, are locally recontextualized.

  1. 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

    ... 16, 2009 (74 FR 3055), FDA announced the availability of the draft guidance of the same title dated... Additional Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products... Tissue Practice (CGTP) and Additional Requirements for Manufacturers of Human Cells, Tissues,...

  2. Current good manufacturing practice in plant automation of biological production processes.

    PubMed

    Dorresteijn, R C; Wieten, G; van Santen, P T; Philippi, M C; de Gooijer, C D; Tramper, J; Beuvery, E C

    1997-01-01

    The production of biologicals is subject to strict governmental regulations. These are drawn up in current good manufacturing practices (cGMP), a.o. by the U.S. Food and Drug Administration. To implement cGMP in a production facility, plant automation becomes an essential tool. For this purpose Manufacturing Execution Systems (MES) have been developed that control all operations inside a production facility. The introduction of these recipe-driven control systems that follow ISA S88 standards for batch processes has made it possible to implement cGMP regulations in the control strategy of biological production processes. Next to this, an MES offers additional features such as stock management, planning and routing tools, process-dependent control, implementation of software sensors and predictive models, application of historical data and on-line statistical techniques for trend analysis and detection of instrumentation failures. This paper focuses on the development of new production strategies in which cGMP guidelines are an essential part.

  3. 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

  4. 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.

  5. 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.

  6. 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.

  7. Production of mesenchymal stromal/stem cells according to good manufacturing practices: a review.

    PubMed

    Sensebé, Luc; Gadelorge, Mélanie; Fleury-Cappellesso, Sandrine

    2013-06-07

    Because of their multi/pluripotency and immunosuppressive properties, mesenchymal stem/stromal cells (MSCs) are important tools for treating immune disorders and for tissue repair. The increasing use of MSCs, their definition as advanced-therapy medicinal products in European regulations, and the US Food and Drug Administration requirements for their production and use imply the use of production processes that should be in accordance with Good Manufacturing Practices (GMPs). Complying with GMPs requires precisely defining the production process (es) as well as the multiple criteria required for a quality final product. Such variables include the environment, staff training and qualification, and controls. Developing processes based on well-defined or completely defined media and operating in closed systems or bioreactors is important and will increase safety and reproducibility. One of the most challenging issues remains implementation of relevant and reproducible controls for safety and efficacy. A linking of researchers, research and development teams, producers, and clinicians is mandatory to achieve GMP-compliant processes with relevant controls for producing well-defined, safe, and efficient MSCs.

  8. Production of mesenchymal stromal/stem cells according to good manufacturing practices: a review.

    PubMed

    Sensebé, Luc; Gadelorge, Mélanie; Fleury-Cappellesso, Sandrine

    2013-01-01

    Because of their multi/pluripotency and immunosuppressive properties, mesenchymal stem/stromal cells (MSCs) are important tools for treating immune disorders and for tissue repair. The increasing use of MSCs, their definition as advanced-therapy medicinal products in European regulations, and the US Food and Drug Administration requirements for their production and use imply the use of production processes that should be in accordance with Good Manufacturing Practices (GMPs). Complying with GMPs requires precisely defining the production process (es) as well as the multiple criteria required for a quality final product. Such variables include the environment, staff training and qualification, and controls. Developing processes based on well-defined or completely defined media and operating in closed systems or bioreactors is important and will increase safety and reproducibility. One of the most challenging issues remains implementation of relevant and reproducible controls for safety and efficacy. A linking of researchers, research and development teams, producers, and clinicians is mandatory to achieve GMP-compliant processes with relevant controls for producing well-defined, safe, and efficient MSCs. PMID:23751270

  9. 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

    ... correcting the January 16, 2013 (78 FR 3646), proposed rule entitled ``Current Good Manufacturing Practice... Appendix in which all references are numbered incorrectly. This document corrects those errors. In FR Doc... proposed rule to establish CGMP requirements for dietary ingredients and dietary supplements (68 FR...

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

    PubMed

    1993-08-01

    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.

  11. Radiation decontamination of pharmaceutical raw materials as an integral part of the good pharmaceutical manufacturing practice (GPMP)

    NASA Astrophysics Data System (ADS)

    Ražem, D.; Katušin-Ražem, B.; Starčević, M.; Galeković, B.

    The microbiological quality of many raw materials used in the manufacture of pharmaceutical and adjuvants often fails to meet the standards set by the pharmaceutical industry. Raw materials of biological provenience are particularly susceptible to contamination. This work describes the present situation regarding the microbial load of corn starch. Given the accepted microbiological criteria, irradiation treatment is proposed as integral to Good Pharmaceutical Manufacturing Practice (GPMP). The use of total viable count as a guide for specifying microbial limits for non-sterile materials is supported. Criteria for the choice of dose are discussed.

  12. Standard operating procedure for the good manufacturing practice-compliant production of human bone marrow mesenchymal stem cells.

    PubMed

    Roseti, Livia; Serra, Marta; Bassi, Alessandra

    2015-01-01

    According to the European Regulation (EC 1394/2007), Mesenchymal Stem Cells expanded in culture for clinical use are considered as Advanced Therapy Medicinal Products. As a consequence, they must be produced in compliance with Good Manufacturing Practice in order to ensure safety, reproducibility, and efficacy. Here, we report a Standard Operating Procedure describing the Good Manufacturing Practice-compliant production of Bone Marrow-derived Mesenchymal Stem Cells suitable for autologous implantation in humans. This procedure can be considered as a template for the development of investigational medicinal Mesenchymal Stem Cells-based product protocols to be enclosed in the dossier required for a clinical trial approval. Possible clinical applications concern local uses in the regeneration of bone tissue in nonunion fractures or in orthopedic and maxillofacial diseases characterized by a bone loss.

  13. 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.

  14. 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. PMID:24922980

  15. Production of good manufacturing practice-grade human umbilical cord blood-derived mesenchymal stem cells for therapeutic use.

    PubMed

    Van Pham, Phuc; Phan, Ngoc Kim

    2015-01-01

    Human umbilical cord blood-derived mesenchymal stem cells (UCB-MSCs) are multipotent stem cells that can be differentiated into several specific cell types such as adipocytes, osteoblasts, and chondroblasts. They also were demonstrated to trans-differentiate into other cell lineages such as muscle cells and neurons. Thus, they are considered a promising stem cell source for therapeutic use. Here, we describe a method for production of good manufacturing practice-grade human UCB-MSCs for therapeutic use. The obtained UCB-MSCs are free of allogenous or xenogenous proteins. In addition, these MSCs could maintain the MSC phenotype in long-term culture.

  16. Impact of current good manufacturing practices and emission regulations and guidances on the discharge of pharmaceutical chemicals into the environment from manufacturing, use, and disposal.

    PubMed Central

    Velagaleti, Ranga; Burns, Philip K; Gill, Michael; Prothro, James

    2002-01-01

    The current Good Manufacturing Practice (cGMP) and effluent emission (use and disposal) regulations of the U.S. Food and Drug Administration (FDA) and manufacturing effluent discharge and emission regulations of the U.S. Environmental Protection Agency (U.S. EPA) require contained manufacture, use, and disposal of pharmaceuticals with the goal of minimizing the release of pharmaceutical chemicals into the environment. However, debate has recently arisen in several scientific forums over whether these regulations adequately protect human and environmental health from the new pharmaceutical drugs introduced each year into the marketplace and the multitude of existing products, each with many distinct biochemical modes of actions. To address this issue, it is important to understand the relevance of current cGMP regulations and emission regulations that have a direct bearing on the releases of pharmaceutical chemicals into the environment during the manufacture, use, and disposal of active pharmaceutical ingredients (drug substances) and drug products. This knowledge may help us assess the quantity of residues that may be released into the environment. Additionally, the information on physical, chemical, and degradation and sorption properties of the pharmaceutical chemicals may help determine the net residue levels that could persist in the environment to evaluate if such residues have any bearing on human and environmental health. The scientific and regulatory aspects of issues related to the manufacture, use, and disposal of pharmaceutical chemicals are discussed in this article, with special emphasis on potential environmental exposure pathways during the life cycle of an active pharmaceutical ingredient or drug product. The mechanisms of degradation (transformation or depletion) and dilution of pharmaceutical residues that may be released into aquatic or terrestrial environmental compartments are described. Such degradation and dilution of pharmaceutical

  17. 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

    ... manufactured, and should have an independent air handling system. A draft version of this guidance was... practices regulation (21 CFR 10.115). The guidance represents the Agency's current thinking on...

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

    PubMed

    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 (68)Ga radionuclide would provide worldwide accessibility of the agent. GMP compliant, reliable and highly reproducible production of [(68)Ga]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

  19. 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

  20. 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

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

    PubMed

    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 (68)Ga radionuclide would provide worldwide accessibility of the agent. GMP compliant, reliable and highly reproducible production of [(68)Ga]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.

  2. Good manufacturing practice-compliant isolation and culture of human umbilical cord blood-derived mesenchymal stem cells

    PubMed Central

    2014-01-01

    Background Mesenchymal stem cells (MSCs) are an attractive source of stem cells for clinical applications. These cells exhibit a multilineage differentiation potential and strong capacity for immune modulation. Thus, MSCs are widely used in cell therapy, tissue engineering, and immunotherapy. Because of important advantages, umbilical cord blood-derived MSCs (UCB-MSCs) have attracted interest for some time. However, the applications of UCB-MSCs are limited by the small number of recoverable UCB-MSCs and fetal bovine serum (FBS)-dependent expansion methods. Hence, this study aimed to establish a xenogenic and allogeneic supplement-free expansion protocol. Methods UCB was collected to prepare activated platelet-rich plasma (aPRP) and mononuclear cells (MNCs). aPRP was applied as a supplement in Iscove modified Dulbecco medium (IMDM) together with antibiotics. MNCs were cultured in complete IMDM with four concentrations of aPRP (2, 5, 7, or 10%) or 10% FBS as the control. The efficiency of the protocols was evaluated in terms of the number of adherent cells and their expansion, the percentage of successfully isolated cells in the primary culture, surface marker expression, and in vitro differentiation potential following expansion. Results The results showed that primary cultures with complete medium containing 10% aPRP exhibited the highest success, whereas expansion in complete medium containing 5% aPRP was suitable. UCB-MSCs isolated using this protocol maintained their immunophenotypes, multilineage differentiation potential, and did not form tumors when injected at a high dose into athymic nude mice. Conclusion This technique provides a method to obtain UCB-MSCs compliant with good manufacturing practices for clinical application. PMID:24565047

  3. [Elaboration of an interactive educational CD-R on good laboratory practices for manufacturing and quality control].

    PubMed

    Nivet, J-M

    2005-11-01

    cGMPs require that QA systems rely upon qualified personnel in charge of pharmaceutical operations. In order to achieve this legal requirement, the manufacturer must provide initial training and regular re-training along with periodical evaluations of their practical efficiency. This cGMP-learning multimedia CD-R is an interactive and individual training tool, designed for QC laboratory personnel. It contains a final questionnaire allowing an assessment of the course efficiency. Building up a ten-module teaching program entitled "Le médicament en toute confiance", the development of this CD-R was supervised by an European team of experienced industrial pharmacists. PMID:16292235

  4. Good Laboratory Practice

    NASA Astrophysics Data System (ADS)

    Hadjicostas, Evsevios

    The principles of Good Laboratory Practice (GLP) in conjunction with the principles of Total Quality Management (see chapter 6) ensure the quality and reliability of the laboratory results, which in turn help to ensure the protection of the environment and human health and safety. A step further is the accreditation of laboratories to ISO 17025 (see chapter 2) to perform specified activities.

  5. Raising the standard: changes to the Australian Code of Good Manufacturing Practice (cGMP) for human blood and blood components, human tissues and human cellular therapy products.

    PubMed

    Wright, Craig; Velickovic, Zlatibor; Brown, Ross; Larsen, Stephen; Macpherson, Janet L; Gibson, John; Rasko, John E J

    2014-04-01

    In Australia, manufacture of blood, tissues and biologicals must comply with the federal laws and meet the requirements of the Therapeutic Goods Administration (TGA) Manufacturing Principles as outlined in the current Code of Good Manufacturing Practice (cGMP). The Therapeutic Goods Order (TGO) No. 88 was announced concurrently with the new cGMP, as a new standard for therapeutic goods. This order constitutes a minimum standard for human blood, tissues and cellular therapeutic goods aimed at minimising the risk of infectious disease transmission. The order sets out specific requirements relating to donor selection, donor testing and minimisation of infectious disease transmission from collection and manufacture of these products. The Therapeutic Goods Manufacturing Principles Determination No. 1 of 2013 references the human blood and blood components, human tissues and human cellular therapy products 2013 (2013 cGMP). The name change for the 2013 cGMP has allowed a broadening of the scope of products to include human cellular therapy products. It is difficult to directly compare versions of the code as deletion of some clauses has not changed the requirements to be met, as they are found elsewhere amongst the various guidelines provided. Many sections that were specific for blood and blood components are now less prescriptive and apply to a wider range of cellular therapies, but the general overall intent remains the same. Use of 'should' throughout the document instead of 'must' allows flexibility for alternative processes, but these systems will still require justification by relevant logical argument and validation data to be acceptable to TGA. The cGMP has seemingly evolved so that specific issues identified at audit over the last decade have now been formalised in the new version. There is a notable risk management approach applied to most areas that refer to process justification and decision making. These requirements commenced on 31 May 2013 and a 12 month

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

    PubMed

    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

    2013-07-01

    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

  7. 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

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

    PubMed

    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

    2013-07-01

    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.

  9. Good Clinical Practice Training

    PubMed Central

    Arango, Jaime; Chuck, Tina; Ellenberg, Susan S.; Foltz, Bridget; Gorman, Colleen; Hinrichs, Heidi; McHale, Susan; Merchant, Kunal; Shapley, Stephanie; Wild, Gretchen

    2016-01-01

    Good Clinical Practice (GCP) is an international standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials. The goal of GCP is to ensure the protection of the rights, integrity, and confidentiality of clinical trial participants and to ensure the credibility and accuracy of data and reported results. In the United States, trial sponsors generally require investigators to complete GCP training prior to participating in each clinical trial to foster GCP and as a method to meet regulatory expectations (ie, sponsor’s responsibility to select qualified investigators per 21 CFR 312.50 and 312.53(a) for drugs and biologics and 21 CFR 812.40 and 812.43(a) for medical devices). This training requirement is often extended to investigative site staff, as deemed relevant by the sponsor, institution, or investigator. Those who participate in multiple clinical trials are often required by sponsors to complete repeated GCP training, which is unnecessarily burdensome. The Clinical Trials Transformation Initiative convened a multidisciplinary project team involving partners from academia, industry, other researchers and research staff, and government to develop recommendations for streamlining current GCP training practices. Recommendations drafted by the project team, including the minimum key training elements, frequency, format, and evidence of training completion, were presented to a broad group of experts to foster discussion of the current issues and to seek consensus on proposed solutions. PMID:27390628

  10. 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

  11. 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.

  12. 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.

  13. 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. PMID:25762106

  14. In situ cryopreservation of human embryonic stem cells in gas-permeable membrane culture cassettes for high post-thaw yield and good manufacturing practice.

    PubMed

    Amps, K J; Jones, M; Baker, D; Moore, H D

    2010-06-01

    The development of efficient and robust methods for the cryopreservation of human embryonic stem cells (hESCs) is important for the production of master and working cell banks for future clinical applications. Such methods must meet requirements of good manufacturing practice (GMP) and maintain genetic stability of the cell line. We investigated the culture of four Shef hESC lines in gas permeable 'culture cassettes' which met GMP compliance. hESCs adhered rapidly to the membrane and colonies displayed good proliferation and expansion. After 5-7 days of culture, hESCs were cryopreserved in situ using 10% dimethyl sulphoxide in foetal calf serum at approximately 1 degrees C/min. This method was compared with a control of standard flask culture and cryopreservation in vials. Post-thaw cassette culture displayed relative proliferation ratios (fold increase above flask/cryovial culture) of 114 (Shef 4), 8.2 (Shef 5), 195 (shef 6) and 17.5 (Shef 7). The proportion of cells expressing pluripotency markers after cryopreservation was consistently greater in cassette culture than for the control with the markers SSEA3 and SSEA4 exhibiting a significant increase (P> or =0.05). The efficiency of cell line culture in cassette was associated with the overall passage number of the cell line. The procedure enables cryopreservation of relatively large quantities of hESCs in situ, whilst returning high yields of viable, undifferentiated stem cells, thereby increasing capacity to scale up with greater efficacy.

  15. Good Practices for Hood Use.

    ERIC Educational Resources Information Center

    Mikell, William G.; Drinkard, William C.

    1984-01-01

    Describes safety practices for laboratory fume hoods based on certain assumptions of hood design and performance. Also discusses the procedures in preparing to work at a hood. A checklist of good hood practices is included. (JM)

  16. Good manufacturing practice-compliant animal-free expansion of human bone marrow derived mesenchymal stroma cells in a closed hollow-fiber-based bioreactor.

    PubMed

    Nold, Philipp; Brendel, Cornelia; Neubauer, Andreas; Bein, Gregor; Hackstein, Holger

    2013-01-01

    Mesenchymal stroma cells (MSC) are increasingly recognized for various applications of cell-based therapies such as regenerative medicine or immunomodulatory treatment strategies. Standardized large-scale expansions of MSC under good manufacturing practice (GMP)-compliant conditions avoiding animal derived components are mandatory for further evaluation of these novel therapeutic approaches in clinical trials. We applied a novel automated hollow fiber cell expansion system (CES) for in vitro expansion of human bone marrow derived MSC employing a GMP-compliant culture medium with human platelet lysate (HPL). Between 8 and 32 ml primary bone marrow aspirate were loaded into the hollow fiber CES and cultured for 15-27 days. 2-58 million MSC were harvested after primary culture. Further GMP-compliant cultivation of second passage MSC for 13 days led to further 10-20-fold enrichment. Viability, surface antigen expression, differentiation capacity and immunosuppressive function of MSC cultured in the hollow fiber CES were in line with standard criteria for MSC definition. We conclude that MSC can be enriched from primary bone marrow aspirate in a GMP-conform manner within a closed hollow fiber bioreactor and maintain their T lymphocyte inhibitory capacity. Standardized and reliable conditions for large scale MSC expansion pave the way for safe applications in humans in different therapeutic approaches.

  17. 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.

  18. 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.

  19. Good manufacturing practice production of self-complementary serotype 8 adeno-associated viral vector for a hemophilia B clinical trial.

    PubMed

    Allay, James A; Sleep, Susan; Long, Scott; Tillman, David M; Clark, Rob; Carney, Gael; Fagone, Paolo; McIntosh, Jenny H; Nienhuis, Arthur W; Davidoff, Andrew M; Nathwani, Amit C; Gray, John T

    2011-05-01

    To generate sufficient clinical-grade vector to support a phase I/II clinical trial of adeno-associated virus serotype 8 (AAV8)-mediated factor IX (FIX) gene transfer for hemophilia B, we have developed a large-scale, good manufacturing practice (GMP)-compatible method for vector production and purification. We used a 293T-based two-plasmid transient transfection system coupled with a three-column chromatography purification process to produce high-quality self-complementary AAV2/8 FIX clinical-grade vector. Two consecutive production campaigns using a total of 432 independent 10-stack culture chambers produced a total of ∼2 × 10(15) vector genomes (VG) by dot-blot hybridization. Benzonase-treated microfluidized lysates generated from pellets of transfected cells were purified by group separation on Sepharose beads followed by anion-exchange chromatography. The virus-containing fractions were further processed by gel filtration and ultrafiltration, using a 100-kDa membrane. The vector was formulated in phosphate-buffered saline plus 0.25% human serum albumin. Spectrophotometric analysis suggested ∼20% full particles, with only low quantities of nonviral proteins were visible on silver-stained sodium dodecyl sulfate-polyacrylamide gels. A sensitive assay for the detection of replication-competent AAV was developed, which did reveal trace quantities of such contaminants in the final product. Additional studies have confirmed the long-term stability of the vector at -80°C for at least 24 months and for at least 24 hr formulated in the clinical diluent and stored at room temperature within intravenous bags. This material has been approved for use in clinical trials in the United States and the United Kingdom.

  20. A seven-year storage report of good manufacturing practice-grade naked plasmid DNA: stability, topology, and in vitro/in vivo functional analysis.

    PubMed

    Walther, Wolfgang; Schmeer, Marco; Kobelt, Dennis; Baier, Ruth; Harder, Alexander; Walhorn, Volker; Anselmetti, Dario; Aumann, Jutta; Fichtner, Iduna; Schleef, Martin

    2013-12-01

    The great interest for naked plasmid DNA in gene therapy studies is reflected by the fact that it is currently used in 18% of all gene therapy trials. Therefore, validation of topology and functionality of DNA resulting from its long-term stability is an essential requirement for safe and effective gene transfer. To this aim, we analyzed the stability of good manufacturing practice-grade pCMVβ reporter plasmid DNA by capillary gel electrophoresis, agarose gel electrophoresis, and atomic force microscopy. The plasmid DNA was produced for a clinical gene transfer study started in 2005 and was stored for meanwhile 7 years under continuously monitored conditions at -20 °C. The stability of plasmid DNA was monitored by LacZ transgene expression functional assays performed in vitro and in vivo on the 7-year-old plasmid DNA samples compared with plasmid batches newly produced in similar experimental conditions and quality standards. The analyses revealed that during the overall storage time and conditions, the proportion of open circular and supercoiled or covalently closed circular forms is conserved without linearization or degradation of the plasmid. The in vitro transfection and the in vivo jet-injection of DNA showed unaltered functionality of the long-stored plasmid. In summary, the 7-year-old and the newly produced plasmid samples showed similar topology and expression performance. Therefore, our stable storage conditions are effective to preserve the integrity of the DNA to be used in clinical studies. This is an important prerequisite for the long-term performance of gene transfer materials used in trials of long duration as well as of the reference material used in standardization procedures and assays.

  1. Practicing Good Habits, Grade 2.

    ERIC Educational Resources Information Center

    Nguyen Van Quan; And Others

    This illustrated primer, designed for second grade students in Vietnam, consists of stories depicting rural family life in Vietnam. The book is divided into the following six chapters: (1) Practicing Good Habits (health, play, helpfulness); (2) Duties at Home (grandparents, father and mother, servants, the extended family; (3) Duties in School…

  2. 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. PMID:12071777

  3. 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.

  4. Marketing manufactured housing under the ''Super Good Cents'' Program

    SciTech Connect

    Mohler, B.L.; Smith, S.A.

    1986-01-01

    The objective of this study is to propose a strategy for including manufactured housing (MH) in Bonneville Power Administration's Super Good Cents (SGC) Program. This report presents information on the site-built SGC program, the characterization of MH consumers, the options for including MH in the SGC program, and the recommendations for including MHs in the SGC program. The purposed strategy for including MHs in the SGC program is designed to reduce risks to manufacturers and dealers, stimulate demand, and allow for maximum flexibility.

  5. 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…

  6. 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.

  7. 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…

  8. 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…

  9. Guide to good practices for shift routines and operating practices

    SciTech Connect

    1998-12-01

    This Guide to Good Practices is written to enhance understanding of, and provide direction for, ``Shift Routines and Operating Practices,`` Chapter 2 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 shift routines and operating practices. ``Shift Routines and Operating Practices`` 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 high standard of professional conduct and sound operating practices to promote safe and efficient operations. Recently, guidance pertaining to this element has been strengthened for nuclear power reactors. This additional guidance is given in Appendix C for information purposes. Though this guidance and good practices pertain to nuclear power reactors, DOE sites may choose to use a graded approach for implementing these in nuclear facilities.

  10. Guide to good practices for operations turnover

    SciTech Connect

    1998-12-01

    This Guide to Good Practices is written to enhance understanding of, and provide direction for, Operations Turnover, Chapter XII 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 operations turnover programs. Contractors are advised to adopt procedures that meet the intent of DOE Order 5480.19. Operations Turnover 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 formal operations turnover program to promote safe and efficient operations.

  11. Guide to good practices for communications

    SciTech Connect

    1998-12-01

    This Guide to Good Practices is written to enhance understanding of, and provide direction for, Communications, Chapter 4 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 communication programs. Contractors are advised to adopt procedures that meet the intent of DOE Order 5480.19. ``Communications`` is an element of an effective Conduct of Operations program. The complexity and array of activities performed in DOE facilities dictate the necessity for high reliability in communications to promote safe and efficient operations.

  12. Guide to good practices for logkeeping

    SciTech Connect

    1998-12-01

    This Guide to Good Practices is written to enhance understanding of, and provide direction for, Logkeeping, Chapter XI 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 logkeeping programs. Contractors are advised to adopt procedures that meet the intent of DOE Order 5480.19. Logkeeping is an element of an effective Conduct of Operations program. The complexity and array of activities performed in DOE facilities dictate the need for a consistent logkeeping program to promote safe and efficient operations.

  13. Guide to good practices for independent verification

    SciTech Connect

    1998-12-01

    This Guide to Good Practices is written to enhance understanding of, and provide direction for, Independent Verification, Chapter X 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 independent verification activities. Contractors are advised to adopt procedures that meet the intent of DOE Order 5480.19. Independent Verification is an element of an effective Conduct of Operations program. The complexity and array of activities performed in DOE facilities dictate the necessity for coordinated independent verification activities to promote safe and efficient operations.

  14. Good clinical practices in phase I studies.

    PubMed

    Decousus, H; Perpoint, B; Mismetti, P; Ollagnier, M; Queneau, P

    1990-01-01

    In France, official guidelines for good clinical practices in clinical trials were issued in 1987. In December 1988, a law was passed that fixed the requirements for carrying out experiments in healthy subjects. It will be completed by official guidelines for the structures in which experiments on healthy subjects (and patients as well, when the investigation would not benefit the health of the patients) may be conducted. Hence a battery of recent legal instructions precisely state what good clinical practices are in the setting of phase I studies. Of particular importance are: subject recruitment and selection methods and procedures; specific competence of the investigator, in particular to interpret the pre-trial data; necessary and sufficient facilities to guarantee the subjects' safety; careful quality control to check all laboratory procedures; necessity of written standard operating procedures.

  15. Editorial: A Note on Good Research Practice

    SciTech Connect

    Dooley, James J.

    2013-07-01

    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 see 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.

  16. 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.

  17. 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. PMID:27297513

  18. Good operating practices cut water pollution

    SciTech Connect

    West, D.E.

    1982-07-12

    This paper explains how the pipeline industry can avoid violating the Clean Water Act (PL 92-500, Federal Water Pollution Control Act), which states that pollution of US waters from any cause other than an act of God, war or Government negligence is the responsibility of the owner or operator of the facility. Reporting pollution to the National Response Center will limit the maximum penalty to $5,000 Rectifiers must be kept in top operating condition, and visual inspections of the right-of-way by aerial or ground patrols must detect construction of new pipelines or other facilities. Accidental damage by third parties is the major cause of failures in pipeline systems, which can be prevented by periodic contact with landowners. Conclusion is that if a pipeline operator follows good operating and maintenance practices, his exposure to effects of the Clean Water Act will be minimal.

  19. Insights into good hot oiling practices

    SciTech Connect

    Mansure, A.J. ); Barker, K.M. )

    1992-01-01

    One of the common oil-field wellbore problems is paraffin deposition. Even though hot oiling is usually the first method tried for removing paraffin, few operators appreciate the limitations of hot oiling and the potential for hot oiling to aggravate well problems and cause formation damage. Several hot oiling jobs were monitored to understand old pumpers tales'' and the dynamics of hot oiling. The field work was supported with laboratory analyses of the oil and calculations of thermal effectiveness. This limited study has shown that the chemical and thermal processes that occur during hot oiling are very complex and that there are significant variations in practices among operators. Key findings of this work include: (1) During a typical hot oiling job, a significant amount of the oil injected into the annulus goes into the formation, and hence, has the potential to damage the formation. (2) Organic particulates in stock tank oil may not completely dissolve/met as the oil passes through the hot-oiling-truck heat exchanger, hence, these particulates may plug the formation. (3) Hot oiling can vaporize oil in the tubing faster than the pump lifts oil. This interrupts paraffin removal from the well, and thus, since the wax is not removed from the well the wax is refined into harder deposits, can go deeper into the well, and can stick rods. These insights have been used to determine good hot oiling practices designed to maximize wax removal and minimize formation damage.

  20. Good practice in multimedia courseware development.

    PubMed

    Schulz, C

    1998-01-01

    The main goal of the European TALENT/ESPRIT project is to create a generic environment for developing multimedia courseware. The first phase of the project concerns itself with developing conversion tools for converting text based course material into multimedia format. The second phase of the project adds network support to the courseware in the form of the network tutoring and networked supply chain support. One year into the project specifications for developing multimedia have been made and can be found in the project's deliverables. Also a summary of good practice in multimedia courseware development has been drawn up. First phase demonstrators (converted text based courses) are currently being prepared. This article starts with a global overview of the TALENT project itself. In more detail an overview of best practice guidelines in multimedia courseware development will be given. The information shown was obtained from an extensive survey among experts in the field of computer based training. The survey was conducted early this year as part of one of the project's deliverables. Finally some comments will be made on a multimedia demonstrator which is currently under development at HISCOM. PMID:10179628

  1. 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…

  2. 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…

  3. Good editorial practice: editors as educators.

    PubMed

    Marusić, M; Marusić, A

    2001-04-01

    There may be valuable research going on in the developing and financially less-privileged countries, but it usually does not reach international visibility, in spite of a large number of scientific journals in these countries. Such journals are not only invisible but, by perpetuating a vicious circle of inadequacy, may be directly damaging to the local science and research culture. We call for an international action to help journal editors in less privileged countries. International associations of editors may be leaders of these activities by defining, promoting, and perhaps controlling good editorial practice, as a main criterion for international recognition of a journal. However, the editors of small journals have the power and moral obligation to become a stronghold of quality and advancement in their scientific community. Their educational "tools" are editorial integrity and author-friendly policy. Editors can teach the authors study design, statistical analysis, precision, punctuality, research integrity, style and format of writing, and other aspects of scientific communication. The editors of "big", mainstream scientific journals can act as global educators, teaching and providing guidance to editors of small journals. The editors from developed countries as leaders, and editors from less advantageous environments as teachers are the key figures in shaping research communication in less privileged scientific communities.

  4. 78 FR 16824 - Tobacco Product Manufacturing Practice; Establishment of a Public Docket

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-19

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Chapter I Tobacco Product Manufacturing Practice... docket to obtain input on recommendations for regulations on good manufacturing practice for tobacco products that were submitted to FDA by a group of 13 tobacco companies (tobacco companies'...

  5. Defense programs beryllium good practice guide

    SciTech Connect

    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 chronic 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 likely 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...

  7. 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...

  8. 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...

  9. 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...

  10. [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

  11. 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...

  12. 21 CFR 1271.150 - Current good tissue practice requirements.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 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...

  13. 21 CFR 1271.150 - Current good tissue practice requirements.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 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...

  14. Establishment and operation of a Good Manufacturing Practice-compliant allogeneic Epstein-Barr virus (EBV)-specific cytotoxic cell bank for the treatment of EBV-associated lymphoproliferative disease.

    PubMed

    Vickers, Mark A; Wilkie, Gwen M; Robinson, Nicolas; Rivera, Nadja; Haque, Tanzina; Crawford, Dorothy H; Barry, Jacqueline; Fraser, Neil; Turner, David M; Robertson, Victoria; Dyer, Phil; Flanagan, Peter; Newlands, Helen R; Campbell, John; Turner, Marc L

    2014-11-01

    Epstein-Barr virus (EBV) is associated with several malignancies, including post-transplant lymphoproliferative disorder (PTLD). Conventional treatments for PTLD are often successful, but risk organ rejection and cause significant side effects. EBV-specific cytotoxic T lymphocytes (CTLs) generated in vitro from peripheral blood lymphocytes provide an alternative treatment modality with few side effects, but autologous CTLs are difficult to use in clinical practice. Here we report the establishment and operation of a bank of EBV-specific CTLs derived from 25 blood donors with human leucocyte antigen (HLA) types found at high frequency in European populations. Since licensure, there have been enquiries about 37 patients, who shared a median of three class I and two class II HLA types with these donors. Cells have been infused into ten patients with lymphoproliferative disease, eight of whom achieved complete remission. Neither patient with refractory disease was matched for HLA class II. Both cases of EBV-associated non-haematopoietic sarcoma receiving cells failed to achieve complete remission. Thirteen patients died before any cells could be issued, emphasizing that the bank should be contacted before patients become pre-terminal. Thus, this third party donor-derived EBV-specific CTL cell bank can supply most patients with appropriately matched cells and most recipients have good outcomes. PMID:25066775

  15. Establishment and operation of a Good Manufacturing Practice-compliant allogeneic Epstein-Barr virus (EBV)-specific cytotoxic cell bank for the treatment of EBV-associated lymphoproliferative disease.

    PubMed

    Vickers, Mark A; Wilkie, Gwen M; Robinson, Nicolas; Rivera, Nadja; Haque, Tanzina; Crawford, Dorothy H; Barry, Jacqueline; Fraser, Neil; Turner, David M; Robertson, Victoria; Dyer, Phil; Flanagan, Peter; Newlands, Helen R; Campbell, John; Turner, Marc L

    2014-11-01

    Epstein-Barr virus (EBV) is associated with several malignancies, including post-transplant lymphoproliferative disorder (PTLD). Conventional treatments for PTLD are often successful, but risk organ rejection and cause significant side effects. EBV-specific cytotoxic T lymphocytes (CTLs) generated in vitro from peripheral blood lymphocytes provide an alternative treatment modality with few side effects, but autologous CTLs are difficult to use in clinical practice. Here we report the establishment and operation of a bank of EBV-specific CTLs derived from 25 blood donors with human leucocyte antigen (HLA) types found at high frequency in European populations. Since licensure, there have been enquiries about 37 patients, who shared a median of three class I and two class II HLA types with these donors. Cells have been infused into ten patients with lymphoproliferative disease, eight of whom achieved complete remission. Neither patient with refractory disease was matched for HLA class II. Both cases of EBV-associated non-haematopoietic sarcoma receiving cells failed to achieve complete remission. Thirteen patients died before any cells could be issued, emphasizing that the bank should be contacted before patients become pre-terminal. Thus, this third party donor-derived EBV-specific CTL cell bank can supply most patients with appropriately matched cells and most recipients have good outcomes.

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

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... implemented for reproductive HCT/Ps described in § 1271.10 and regulated solely under section 361 of the... manufacturing practice regulations in parts 210 and 211 of this chapter and the quality system regulations...

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

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... implemented for reproductive HCT/Ps described in § 1271.10 and regulated solely under section 361 of the... manufacturing practice regulations in parts 210 and 211 of this chapter and the quality system regulations...

  18. 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...

  19. 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,...

  20. 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...

  1. Production of good manufacturing practice-grade cytotoxic T lymphocytes specific for Epstein-Barr virus, cytomegalovirus and adenovirus to prevent or treat viral infections post-allogeneic hematopoietic stem cell transplant.

    PubMed

    Sili, Uluhan; Leen, Ann M; Vera, Juan F; Gee, Adrian P; Huls, Helen; Heslop, Helen E; Bollard, Catherine M; Rooney, Cliona M

    2012-01-01

    Infections with a range of common community viruses remain a major cause of mortality and morbidity after allogeneic hematopoietic stem cell transplantation. T cells specific for cytomegalovirus (CMV), Epstein-Barr virus (EBV) and adenoviruses can safely prevent and infections with these three most common culprits, but the manufacture of individual T cell lines for each virus would be prohibitive in terms of time and cost. We have demonstrated that T cells specific for all three viruses can be manufactured in a single culture using monocytes and EBV-transformed B lymphoblastoid cell lines (LCLs), both transduced with an adenovirus vector expressing pp65 of CMV, as antigen-presenting cells. Trivirus-specific T cell lines produced from healthy stem cell donors could prevent and treat infections with all three viruses, not only in the designated recipient, but in unrelated, partially-HLA-matched third party recipients. We now provide the details and logistics of T cell manufacture.

  2. Promoting Good Statistical Practices: Some Suggestions.

    ERIC Educational Resources Information Center

    Kirk, Roger E.

    2001-01-01

    Makes the case that science is best served when researchers focus on the size of effects and their practical significance. Advocates the use of confidence intervals for deciding whether chance or sampling variability is an unlikely explanation for an observed effect. Calls for more emphasis on effect sizes in the next edition of the American…

  3. The need for good practices in biomedical technology.

    PubMed

    Koech, D K

    1996-02-01

    issued Guidelines for Good Clinical Practice (GCP), Guidelines for Good Manufacturing Practices (GMP) of Pharmaceuticals, and Guidelines for the Production of Biologicals. It is thus evident that quality assurance is a very important aspect in all fields of health science research and practice. Quality assurance embraces quality control and audit and involves three things: personnel and material resources, quality system structure, and management responsibilities. Well trained personnel are required to use the appropriate materials and tools, an efficient quality system structure is desirable, and a good management system to implement the quality assurance programme is very essential. This programme should also enable the providers of goods and services to be bold enough to disclose to the consumers when their goods and services fail, as in the recent case of Abbot Laboratories when they had to withdraw their HIV test kit from the market after failing to meet the prescribed standards. Similarly, some years ago the anti-inflammatory drug Benoxaprofen (ORAFLEX-Eli Lilly) was withdrawn shortly after its introduction in the clinic. Do the organisations in Africa have the capacity to develop, or adopt, a quality assurance programme? It is fair to answer in the affirmative Organisations in Africa can, and should, adopt any of the existing quality assurance programmes that suit their operations best. What is most important is that operations must have the means to establish specificity, accuracy, precision and sensitivity that can be verified and certified. The big question is, do all these nicely worded standards, guidelines and practices have uniform and enforceable laws that enable their effective implementation and protection of the consumers?

  4. The Management of Student Administration: A Guide to Good Practice.

    ERIC Educational Resources Information Center

    Higher Education Funding Council for Wales, Cardiff.

    This report is intended to help institutions review their arrangements for student administration through comparisons with generally recognized good practice and with specific developments and experience in the sector. This study from which the information on good practices was derived was conducted through visits to 11 pilot institutions to…

  5. 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…

  6. 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)…

  7. Isolation of Human Amnion Epithelial Cells According to Current Good Manufacturing Procedures.

    PubMed

    Gramignoli, Roberto; Srinivasan, Raghuraman C; Kannisto, Kristina; Strom, Stephen C

    2016-05-12

    Different cell types can be isolated from human placental tissues, and some have been reported to retain phenotypic plasticity and characteristics that make them a promising source of cells for regenerative medicine. Among these are human amnion epithelial cells (hAECs). Adoption of current good manufacturing practices (cGMP) and enhanced quality control is essential when isolating hAECs in order to deliver a safe and effective cellular product for clinical purposes. This unit describes a detailed protocol for selective isolation of hAECs from human term placenta with little to no contamination by other cell types. A method for characterizing the heterogeneity of the hAEC suspension is also provided. The resulting cell product will be useful for clinical as well as basic research applications. © 2016 by John Wiley & Sons, Inc.

  8. Isolation of Human Amnion Epithelial Cells According to Current Good Manufacturing Procedures.

    PubMed

    Gramignoli, Roberto; Srinivasan, Raghuraman C; Kannisto, Kristina; Strom, Stephen C

    2016-01-01

    Different cell types can be isolated from human placental tissues, and some have been reported to retain phenotypic plasticity and characteristics that make them a promising source of cells for regenerative medicine. Among these are human amnion epithelial cells (hAECs). Adoption of current good manufacturing practices (cGMP) and enhanced quality control is essential when isolating hAECs in order to deliver a safe and effective cellular product for clinical purposes. This unit describes a detailed protocol for selective isolation of hAECs from human term placenta with little to no contamination by other cell types. A method for characterizing the heterogeneity of the hAEC suspension is also provided. The resulting cell product will be useful for clinical as well as basic research applications. © 2016 by John Wiley & Sons, Inc. PMID:27171794

  9. 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...

  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. 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.

  12. 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. PMID:27635232

  13. 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

  14. 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...

  15. 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...

  16. 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...

  17. 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...

  18. 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...

  19. 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...

  20. 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...

  1. 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...

  2. 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...

  3. 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...

  4. 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...

  5. 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...

  6. 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...

  7. 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...

  8. 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...

  9. 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.

  10. Health physics manual of good practices for tritium facilities

    SciTech Connect

    Blauvelt, R.K.; Deaton, M.R.; Gill, J.T.

    1991-12-01

    The purpose of this document is to provide written guidance defining the generally accepted good practices in use at Department of Energy (DOE) tritium facilities. A {open_quotes}good practice{close_quotes} is an action, policy, or procedure that enhances the radiation protection program at a DOE site. The information selected for inclusion in this document should help readers achieve an understanding of the key radiation protection issues at tritium facilities and provide guidance as to what characterizes excellence from a radiation protection point of view. The ALARA (As Low as Reasonable Achievable) program at DOE sites should be based, in part, on following the good practices that apply to their operations.

  11. Guide to good practices for operations aspects of unique processes

    SciTech Connect

    Not Available

    1993-06-01

    This Guide to Good Practices is written to enhance understanding of, and provide direction for, Operations Aspects of Facility Chemistry and Unique Process, Chapter 13 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 employee training and facility management programs. Contractors are advised to adopt procedures that meet the intent of DOE Order 5480.19.

  12. 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. PMID:23189532

  13. 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.

  14. 40 CFR 86.1851-01 - Application of good engineering judgment to manufacturers' decisions.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... engineering judgment in making all decisions called for under this subpart, including but not limited to... overlooked, that the decision was not made in good faith, or that the decision was not made with a rational... judgment to manufacturers' decisions. 86.1851-01 Section 86.1851-01 Protection of Environment...

  15. 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... American Recovery and Reinvestment Act of 2009 § 176.110 Evaluating proposals of foreign iron, steel, and... cost of certain domestic iron, steel, and/or manufactured goods being unreasonable, in accordance...

  16. 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…

  17. Seven Principles for Good Practice in Distance Learning.

    ERIC Educational Resources Information Center

    Tulloch, Jacquelyn

    As enrollments decline, many institutions rush to implement distance education programs, often with only crude or solely administrative guidelines for program development. The following seven principles of good practice can be useful to guide initial program development: (1) programs should have purpose, direction, leadership, and clearly…

  18. Beyond Responsiveness: Promoting Good Practice in Economic Development.

    ERIC Educational Resources Information Center

    Hughes, Maria; Kypri, Photoula

    1998-01-01

    This paper looks at the involvement of further education (FE) colleges in England and Wales in economic development and presents case studies of good practice in nine FE colleges. Chapter 1 addresses FE's role in economic development and measuring and planning economic growth. Chapter 2 contains the case studies: Lewisham College's Action for…

  19. "Good annotation practice" for chemical data in biology.

    PubMed

    Degtyarenko, Kirill; Ennis, Marcus; Garavelli, John S

    2007-01-01

    A structural diagram, in the form of a two-dimensional (2-D) sketch, remains the most effective portrait of a "small molecule" or chemical reaction. However, such structural diagrams, as for any other core data, cannot be used in speech (and should not be used in free text). "Good annotation practice" for biological databases is to use either consistent and widely recognised terminology or unique identifiers from a dedicated database to refer to the molecule of interest. Ideally, scientists should use terminology that is both pronounceable and meaningful. Thus, a viable solution for a bioinformatician is to use a definitive controlled vocabulary of biochemical compounds and reactions, which contains both systematic and common names. In addition, chemical ontologies provide a means for placing entities of interest into wider chemical, biological or medical contexts. We present some challenges and achievements in the standardisation of chemical language in biological databases, with emphasis on three aspects of annotation: 1. good drawing practice: how to draw unambiguous 2-D diagrams; 2. good naming practice: how to give most appropriate names; and 3. good ontology practice: how to link the entity of interest by defined logical relationships to other entities. PMID:17822390

  20. 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…

  1. Guide to good practices for developing learning objectives. DOE Handbook

    SciTech Connect

    1992-07-01

    This guide to good practices provides information and guidance on the types of and development of learning objectives in a systematic approach to training program. This document can serve as a reference during the development of new learning objectives or refinement of existing ones.

  2. 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…

  3. Corruption at the data capture stage and good laboratory practices

    SciTech Connect

    Ziegler, E.; Lenk, H.

    1994-05-01

    Possible sources of data corruption at the data capture stage include errors from the analogue input signal to be sampled, incorrect timing of the realtime sampling, loss of data on the data transmission path, and malfunctions of hardware and software components. Hardware and software measures to avoid such errors and provisions to adhere to good laboratory practice rules are discussed. 9 refs., 3 figs.

  4. 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…

  5. 21 CFR 10.115 - Good guidance practices.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 1 2014-04-01 2014-04-01 false Good guidance practices. 10.115 Section 10.115 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL... office level or if you feel that you are not making progress by going through the chain of command,...

  6. 21 CFR 10.115 - Good guidance practices.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Good guidance practices. 10.115 Section 10.115 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL... office level or if you feel that you are not making progress by going through the chain of command,...

  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. 75 FR 73101 - Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-29

    ... Collection; Comment Request; Current Good Manufacturing Practice Regulations for Medicated Feeds AGENCY: Food... appropriate, and other forms of information technology. Current Good Manufacturing Practice Regulations for... current good manufacturing practice (cGMP) regulations for drugs, including medicated feeds....

  9. 76 FR 31342 - Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-31

    ... Collection; Comment Request; Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals... Current Good Manufacturing Practice (CGMP) Regulations for Finished Pharmaceuticals. DATES: Submit either... of information technology. Current Good Manufacturing Practice Regulations for...

  10. [Changes in the norms governing practices for the manufacture of pharmaceutical products: implications for the MERCOSUR].

    PubMed

    Temprano, G; Prats, S; Bregni, C

    1998-11-01

    It is done a comparative study between the "Recommended rules for drug products manufacturing and inspection", approved in 1975 by the World Health Organization (and still in force in the MERCOSUR); and the standards published in 1992 by the WHO Expert Committee on Specifications for Pharmaceutical Preparations 32nd Report, named "Good Manufacturing Practices for pharmaceutical products". The correspondence between the regulation in force in the MERCOSUR and the Good Manufacturing Practices Inspection Guide for pharmaceutical industry, used by Health Authorities in the Common Market Member States, is analysed. It is noticed a disagreement between the rule in force and the instrument for verifying its fulfillment. The proposal of this article is the adoption by the Common Market Group, of the rules published by the WHO in 1992, and the establishment of an inspection guide which absolute agrees with it.

  11. Clinical audit: Development of the criteria of good practices.

    PubMed

    Soimakallio, S; Alanen, A; Järvinen, H; Ahonen, A; Ceder, K; Lyyra-Laitinen, T; Paunio, M; Sinervo, T; Wigren, T

    2011-09-01

    Clinical audit is a systematic review of the procedures in order to improve the quality and the outcome of patient care, whereby the procedures are examined against agreed standards for good medical RADIOLOGICAL procedures. The criteria of good procedures (i.e. the good practice) are thus the cornerstones for development of clinical audits: these should be the basis of assessments regardless of the type of the audit--external, internal, comprehensive or partial. A lot of criteria for good practices are available through the recommendations and publications by international and national professional societies and other relevant organisations. For practical use in clinical audits, the criteria need to be compiled, sorted out and agreed on for the particular aims of an audit (comprehensive or partial, external or internal). The national professional and scientific societies can provide valuable contribution to this development. For examination--or treatment-specific criteria--preliminary consensus needs to be obtained with the help of clinical experts, while clinical audits can be useful as a benchmarking tool to improve the criteria.

  12. 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.

  13. A model for reflection for good clinical practice.

    PubMed

    Balla, John I; Heneghan, Carl; Glasziou, Paul; Thompson, Matthew; Balla, Margaret E

    2009-12-01

    Rationale and aim The rapidly changing knowledge base of clinical practice highlights the need to keep abreast of knowledge changes that are most relevant for the practitioner. We aimed to develop a model for reflection on clinical practice that identified the key elements of medical knowledge needed for good medical practice. Method The dual theory of cognition, an integration of intuitive and analytic processes, provided the framework for the study. The design looked at the congruence between the clinical thinking process and the dual theory. A one-year study was conducted in general practice clinics in Oxfordshire, UK. Thirty-five general practitioners participated in 20-minute interviews to discuss how they worked through recently seen clinical cases. Over a one-year period 72 cases were recorded from 35 interviews. These were categorized according to emerging themes, which were manually coded and substantiated with verbatim quotations. Results There was a close fit between the dual theory and participants' clinical thinking processes. This included instant problem framing, consistent with automatic intuitive thinking, focusing on the risk and urgency of the case. Salient features accounting for these choices were recognizable. There was a second reflective phase, leading to the review of initial judgements. Conclusions The proposed model highlights the critical steps in decision making. This allows regular recalibration of knowledge that is most critical at each of these steps. In line with good practice, the model also links the crucial knowledge used in decision making, to value judgments made in relation to the patient. PMID:20367693

  14. Guide to good practices for equipment and piping labeling

    SciTech Connect

    1998-12-01

    This Guide to Good Practices is written to enhance understanding of, and provide direction for, Equipment and Piping Labeling, Chapter XVIII 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 labeling programs. Contractors are advised to adopt procedures that meet the intent of DOE Order 5480.19. Equipment and Piping Labeling 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 labeling program to promote safe and efficient operations.

  15. Guide to good practices for operator and postings

    SciTech Connect

    1998-12-01

    This Guide to Good Practices is written to enhance understanding of, and provide direction for, Operator Aid Postings, Chapter XVII 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 operator aid postings. Contractors are advised to adopt procedures that meet the intent of DOE Order 5480.19. Operator Aid Postings is an element of an effective Conduct of Operations program. The complexity and array of activities performed in DOE facilities dictate the necessity for controlling posted information to promote safe and efficient operations.

  16. Guide to good practices for control area activities

    SciTech Connect

    1998-12-01

    This Guide to Good Practices is written to enhance understanding of, and provide direction for, Control Area Activities, Chapter III of Department of Energy (DOE) Order 5480.19, Conduct of Operations Requirements for DOE Facilities. The practices in this guide should be considered for controlling the activities in control areas. Contractors are advised to adopt procedures that meet the intent of DOE Order 5480.19. Control Area Activities is an element of an effective Conduct of Operations program. The complexity and array of activities performed in DOE facilities dictate the necessity for maintaining a formal environment in operational control areas to promote safe and efficient operations.

  17. Guide to good practices for timely orders to operators

    SciTech Connect

    1998-12-01

    This Guide to Good Practices is written to enhance understanding of, and provide direction for, Timely Orders to Operators, Chapter XV 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 Timely Orders to Operators programs. Contractors are advised to adopt procedures that meet the intent of DOE Order 5480.19. Timely Orders to Operators is an element of an effective Conduct of Operations program. The complexity and array of activities performed in DOE facilities dictate the necessity for timely orders to operators to promote safe and efficient operations.

  18. Guide to good practices for operations aspects of unique processes

    SciTech Connect

    1998-12-01

    This Guide to Good Practices is written to enhance understanding of, and provide direction for, Operations Aspects of Facility Chemistry and Unique Processes, Chapter XIII 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 employee training and facility management programs. Contractors are advised to adopt procedures that meet the intent of DOE Order 5480.19. Operations Aspects of Unique Processes is an element of an effective Conduct of Operations program. The complexity and array of activities performed in DOE facilities dictate the necessity for all personnel to coordinate interrelated activities affecting unique processes.

  19. Guide to good practices for the development of test items

    SciTech Connect

    Not Available

    1992-07-01

    The purpose of the Department of Energy (DOE) guide to Good Practices for the Development of Test Items is to provide DOE contractor organizations with information that can be used to modify existing programs with or to develop new programs. DOE contractors should not feel obligated to adopt all of this guide. Rather, they can use the information in this guide to develop programs that apply to their facility. This guide, used in conjunction with DOE Guide to Good Practices for the Design, Development, and Implementation of Examinations, can be used as an aid to provide a framework for the systematic development of valid and reliable examinations. In addition, detailed examples of short answer, multiple-choice, and essay test-item formats are intended to aid in developing effective test items.

  20. 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. PMID:25516950

  1. 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.

  2. Guide to good practices for on-the-job training

    SciTech Connect

    1998-04-01

    Training programs at DOE facilities should prepare personnel to safely and efficiently operate and maintain the facilities in accordance with DOE requirements. This guide presents good practices for a systematic approach to on-the-job training (OJT) and OJT programs and should be used in conjunction with DOE Training Program Handbook: A Systematic Approach to Training, and with the DOE Handbook entitled Alternative Systematic Approaches to Training to develop performance-based OJT programs. DOE contractors may also use this guide to modify existing OJT programs that do not meet the systematic approach to training (SAT) objectives.

  3. Guide to good practices for operations organization and administration

    SciTech Connect

    1998-12-01

    This Guide to Good Practices is written to enhance understanding of, and provide direction for, Operations Organization and Administration, Chapter I 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 operations organization and administration programs. Contractors are advised to adopt procedures that meet the intent of DOE Order 5480.19. This standard should be used in conjunction with principles of the Integrated Safety Management System as incorporated in DOE G 450.4-1, Integrated Safety Management System Guide. Operations Organization and Administration is an element of an effective Conduct of Operations program. The complexity and array of activities performed in DOE facilities dictate the necessity for well-defined standards and requirements for safe and efficient operations.

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

    PubMed Central

    Begnaud, Frédéric

    2016-01-01

    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’. PMID:27644977

  5. 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.

  6. 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. PMID:25564923

  7. Introducing guidelines for good evaluation practice in health informatics.

    PubMed

    Nykänen, Pirkko; Brender, Jytte; Ammenwerth, Elske; Talmon, Jan; de Keizer, Nicolette; Rigby, Michael

    2009-01-01

    Good evaluation practice guidelines have been developed through a consensus making process by a core team and the health informatics community. A set of 60 issues has been identified that is relevant for planning, implementation and execution of an evaluation study in the health informatics domain. These issues cover all phases of an evaluation study: Study exploration, first study design, operationalization of methods, detailed study design, execution and finalization of an evaluation study. Issues of risk management and project control are also addressed in the guidelines. Through application of these guidelines the general validity and generalization of evaluation studies are likely to be increased, since these guidelines aim at avoiding a number of omissions, pitfalls and risks. PMID:19745455

  8. How successful is the dual diagnosis good practice guide?

    PubMed

    Laker, Caroline

    Evidence from the US shows that integrated treatment programmes for dually diagnosed patients are more successful than parallel treatment programmes. In the UK the Dual Diagnosis Good Practice Guide (DDGPG, 2002a), advocates a move towards an integrated system of care delivery. However, the paucity of evidence in the UK and the entrenched nature of the established mental health and addictions services means that current policy is derived from limited information and is struggling to address the process of change. By definition, dual diagnosis is a complex interaction between a range of mental health and substance misuse problems leading to difficulties in allocating appropriate skill mixes to teams. Ethical and legal issues in the mental health services cause conflict with the treatment concepts for substance misuse. The advent of the DDGPG is positive, but there is a clear need for further work in this area.

  9. Good Practice Guide Waste Minimization/Pollution Prevention

    SciTech Connect

    J Dorsey

    1999-10-14

    This Good Practice Guide provides tools, information, and examples for promoting the implementation of pollution prevention during the design phases of U.S. Department of Energy (DOE) projects. It is one of several Guides for implementing DOE Order 430.1, Life-cycle Asset Management. DOE Order 430.1 provides requirements for DOE, in partnership with its contractors, to plan, acquire, operate, maintain, and dispose of physical assets. The goals of designing for pollution prevention are to minimize raw material consumption, energy consumption, waste generation, health and safety impacts, and ecological degradation over the entire life of the facility (EPA 1993a). Users of this Guide will learn to translate national policy and regulatory requirements for pollution prevention into action at the project level. The Guide was written to be applicable to all DOE projects, regardless of project size or design phase. Users are expected to interpret the Guide for their individual project's circumstances, applying a graded approach so that the effort is consistent with the anticipated waste generation and resource consumption of the physical asset. This Guide employs a combination of pollution prevention opportunity assessment (PPOA) methods and design for environment (DfE) philosophies. The PPOA process was primarily developed for existing products, processes, and facilities. The PPOA process has been modified in this Guide to address the circumstances of the DOE design process as delineated in DOE Order 430.1 and its associated Good Practice Guides. This modified form of the PPOA is termed the Pollution Prevention Design Assessment (P2DA). Information on current nationwide methods and successes in designing for the environment also have been reviewed and are integrated into this guidance.

  10. 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. PMID:27117344

  11. Manufactured housing plant injuries in a rural family practice.

    PubMed

    Kellerman, R

    1990-09-01

    The manufacture of mobile homes and prefabricated houses results in the second highest occupational injury and illness rate of any industry. The types of worker injuries sustained have never previously been characterized. This series of 138 injuries from a rural family practice categorizes the injuries sustained by workers in a manufactured housing plant. Most injuries were not judged to be serious, but did result in lost work time and morbidity. Forty-nine percent of all injuries involved lacerations or puncture wounds. Seventy-six percent of puncture wounds involved staple gun use. Two thirds of lacerations were from pieces of metal, siding, and other sharp objects; one third were from knives. Fingers, hands, and wrists were the most commonly injured anatomic sites. Nine cases of overuse injury were seen; two required carpal tunnel surgical release. Twelve injuries were serious enough to require hospitalization or consultation. There were no fatalities. Several suggestions for improved worker safety are presented. PMID:2391457

  12. [Interpretation of Guidelines on Good Pharmacovigilance Practices for European Union].

    PubMed

    Xie, Yan-Ming; Tian, Feng

    2013-09-01

    Due to the limitations of pre-authorization clinical trials, the safety information obtained from them is relatively limited. Therefore, it is very necessary to carry out pharmacovigilance activities on drugs post-marketing. In order to promote the specific implementation of the new pharmacovigilance regulations, the European medicines agency (EMA) developed the Guideline on Good Pharmacovigilance Practices (GVP), as the new criteria for pharmacovigilance in the European Union (EU). Compared with the previously published, Guidelines on Pharmacovigilance for Medicinal Products for Human Use (2007), the GVP proposed more comprehensive and systematic provisions of pharmacovigilance systems, quality control systems, judgements, pharmacovigilance inspections and audits. In addition, it set more specific and comprehensive requirements on risk management systems, the management and reporting of adverse reactions to medicinal products, periodic safety update reports, post-authorization safety studies, signal management, and so on. Interpreting the basic principles, working mechanisms, key technologies and methods of the GVP provides a useful reference for us to carry out pharmacovigilance (especially regarding safety monitoring of parenterally administered Chinese medicine). PMID:24471312

  13. Guide to good practices for the development of test items

    SciTech Connect

    1997-01-01

    While the methodology used in developing test items can vary significantly, to ensure quality examinations, test items should be developed systematically. Test design and development is discussed in the DOE Guide to Good Practices for Design, Development, and Implementation of Examinations. This guide is intended to be a supplement by providing more detailed guidance on the development of specific test items. This guide addresses the development of written examination test items primarily. However, many of the concepts also apply to oral examinations, both in the classroom and on the job. This guide is intended to be used as guidance for the classroom and laboratory instructor or curriculum developer responsible for the construction of individual test items. This document focuses on written test items, but includes information relative to open-reference (open book) examination test items, as well. These test items have been categorized as short-answer, multiple-choice, or essay. Each test item format is described, examples are provided, and a procedure for development is included. The appendices provide examples for writing test items, a test item development form, and examples of various test item formats.

  14. 75 FR 78715 - Small Entity Compliance Guide: Current Good Manufacturing Practice in Manufacturing, Packaging...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-16

    ... Federal Register (72 FR 34959), FDA also issued an interim final rule (the identity testing interim final... Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. Send two self- addressed adhesive labels to..., 301-436-1440. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of June 25, 2007 (72...

  15. Good Practice in Student Affairs: Principles To Foster Student Learning.

    ERIC Educational Resources Information Center

    Blimling, Gregory S.; Whitt, Elizabeth J.

    This book, based on the conclusions of a study of practices in college student affairs, presents nine papers which identify the best practices in student affairs, review research used to define the best practices, and give examples of how to use these practices in the field. The book is based on a 1996 meeting of an interdisciplinary study group…

  16. Publishing integrity and good practices in editing in biomedicine.

    PubMed

    Polenakovic, Momir; Gucev, Zoran

    2014-01-01

    The Macedonian Academy of Sciences and Arts (MASA), held a scientific workshop for journal editors in biomedicine: "Publishing integrity and good practices in editing in biomedicine" on April 25, 2014 in MASA, Skopje. The meeting looked into old problems and new situations in editing and publishing, with emphasis on the situation in developing countries. This global knowledge-based society is founded on the results obtained from scientific research. The data from basic research in developed countries contribute in a quite substantial manner to the newly added economic value. One of the main reasons for underdevelopment in South Eastern Europe (SEE) is certainly a low or non-existent contribution of scientific research in the newly added economic value. This has largely to do with the perception of the political elites which simply lack the insight on the crucial importance of science in development. In the long term this leads to societies in which there are distortions in the understanding of the most basic values. Academic publishing has experienced tremendous growth: so far there are at least 50 million scientific articles. Interestingly, publishing in developing countries has experienced a rate of growth higher than in developed countries. However, this is not the case with the Balkan countries. The meeting looked at some old and some newly emerging problems in editing and publishing. First, the high cost for universities and researchers to purchase journals adversely affects both publishing and editing. In developing countries the high cost of purchasing scientific literature is an almost insurmountable problem in spite of the fact that some publishing companies offer discounted fees. Open access journals in South Eastern European (SEE) countries are hardly achievable as this also incurs costs that have to be covered in some way or other. The peer review process has the fundamental difficulty that reviewers are in the situation of a Procrustean bed, tending to

  17. Publishing integrity and good practices in editing in biomedicine.

    PubMed

    Polenakovic, Momir; Gucev, Zoran

    2014-01-01

    The Macedonian Academy of Sciences and Arts (MASA), held a scientific workshop for journal editors in biomedicine: "Publishing integrity and good practices in editing in biomedicine" on April 25, 2014 in MASA, Skopje. The meeting looked into old problems and new situations in editing and publishing, with emphasis on the situation in developing countries. This global knowledge-based society is founded on the results obtained from scientific research. The data from basic research in developed countries contribute in a quite substantial manner to the newly added economic value. One of the main reasons for underdevelopment in South Eastern Europe (SEE) is certainly a low or non-existent contribution of scientific research in the newly added economic value. This has largely to do with the perception of the political elites which simply lack the insight on the crucial importance of science in development. In the long term this leads to societies in which there are distortions in the understanding of the most basic values. Academic publishing has experienced tremendous growth: so far there are at least 50 million scientific articles. Interestingly, publishing in developing countries has experienced a rate of growth higher than in developed countries. However, this is not the case with the Balkan countries. The meeting looked at some old and some newly emerging problems in editing and publishing. First, the high cost for universities and researchers to purchase journals adversely affects both publishing and editing. In developing countries the high cost of purchasing scientific literature is an almost insurmountable problem in spite of the fact that some publishing companies offer discounted fees. Open access journals in South Eastern European (SEE) countries are hardly achievable as this also incurs costs that have to be covered in some way or other. The peer review process has the fundamental difficulty that reviewers are in the situation of a Procrustean bed, tending to

  18. Addressing the Challenge of Diversity in the Graduate Ranks: Good Practices Yield Good Outcomes

    ERIC Educational Resources Information Center

    Thompson, Nancy L.; Campbell, Andrew G.

    2013-01-01

    In this paper, we examine the impact of implementing three systemic practices on the diversity and institutional culture in biomedical and public health PhD training at Brown University. We hypothesized that these practices, designed as part of the National Institutes of Health-funded Initiative to Maximize Student Development (IMSD) program in…

  19. Educating for Good Work: From Research to Practice

    ERIC Educational Resources Information Center

    Mucinskas, Daniel; Gardner, Howard

    2013-01-01

    Launched in 1995, the GoodWork Project is a long-term, multi-site effort to understand the nature of good work across the professional landscape and to promote its achievement by relevant groups of students and professionals. In this essay, the authors review the goals and methods of the initial research project and its most salient findings. They…

  20. ADE Statement of Good Practice: Teaching, Evaluation, and Scholarship.

    ERIC Educational Resources Information Center

    ADE Bulletin, 2002

    2002-01-01

    Argues that scholarship, broadly defined, is essential to effective teaching and to a satisfying professional life in the humanities. Defines good teaching, and discusses ways to evaluate and encourage good teaching as well as ways to integrate teaching and scholarship. (SG)

  1. Modular glovebox connector and associated good practices for control of radioactive and chemically toxic materials.

    PubMed

    Hoover, M D; Mewhinney, C J; Newton, G J

    1999-01-01

    Design and associated good practices are described for a modular glovebox connector to improve control of radioactive and chemically toxic materials. The connector consists of an anodized aluminum circular port with a mating spacer, gaskets, and retaining rings for joining two parallel ends of commercially available or custom-manufactured glovebox enclosures. Use of the connector allows multiple gloveboxes to be quickly assembled or reconfigured in functional units. Connector dimensions can be scaled to meet operational requirements for access between gloveboxes. Options for construction materials are discussed, along with recommendations for installation of the connector in new or retrofitted systems. Associated good practices include application of surface coatings and caulking, use of disposable glovebags, and proper selection and protection of gasket and glove materials. Use of the connector at an inhalation toxicology research facility has reduced the time and expense required to reconfigure equipment for changing operational requirements, the dispersion of contamination during reconfigurations, and the need for decommissioning and disposal of contaminated enclosures.

  2. Testing and Assessment: An Employer's Guide to Good Practices.

    ERIC Educational Resources Information Center

    Saad, Syed; Carter, Gary W.; Rothenberg, Mark; Israelson, Enid

    This guide was developed to help managers and human resource (HR) professionals use assessment practices that are the right choices for reaching their organizations' HR goals. It provides information about assessment practices so that managers and HR professionals can evaluate and select assessment tools and procedures that maximize chances for…

  3. 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.

  4. 21 CFR 111.123 - What quality control operations are required for the master manufacturing record, the batch...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... the master manufacturing record, the batch production record, and manufacturing operations? 111.123... (CONTINUED) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING... manufacturing record, the batch production record, and manufacturing operations? (a) Quality control...

  5. 21 CFR 111.123 - What quality control operations are required for the master manufacturing record, the batch...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... the master manufacturing record, the batch production record, and manufacturing operations? 111.123... (CONTINUED) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING... manufacturing record, the batch production record, and manufacturing operations? (a) Quality control...

  6. 21 CFR 111.123 - What quality control operations are required for the master manufacturing record, the batch...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... the master manufacturing record, the batch production record, and manufacturing operations? 111.123... (CONTINUED) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING... manufacturing record, the batch production record, and manufacturing operations? (a) Quality control...

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

    ERIC Educational Resources Information Center

    Callan, Patrick M.; Ewell, Peter T.; Finney, Joni E.; Jones, Dennis P.

    2007-01-01

    This report describes a wide range of successful strategies that states can draw from to increase the educational attainment of their residents while holding down higher education costs. Part I offers examples of strategies, programs, and practices that the authors' research finds can raise educational productivity. Part II describes the levers…

  8. Collaborative Practice: The Basis of Good Educational Work

    ERIC Educational Resources Information Center

    James, Chris

    2007-01-01

    It is notoriously difficult to classify occupations as professions and to define professional work. Numerous authors have provided criteria for categorising occupations as professions but the judgement still remains a difficult one. Freidson (1991) is clear that professional work is Good Work. It has a moral purpose and arguably that sense of…

  9. 75 FR 80011 - Good Laboratory Practice for Nonclinical Laboratory Studies

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-21

    ..., 1978 (43 FR 60013). As stated in its scope (Sec. 58.1), this regulation prescribes good laboratory... regulation in 1978. For example, it is presently common for nonclinical laboratory studies to be conducted... ensuring the integrity of resulting data. FDA is considering whether to include in the regulations a...

  10. Good practices in collecting umbilical cord and placental blood 1

    PubMed Central

    Lopes, Lauren Auer; Bernardino, Elizabeth; Crozeta, Karla; Guimarães, Paulo Ricardo Bittencourt

    2016-01-01

    Abstract Objective: to identify the factors related to the quality of umbilical cord and placental blood specimens, and define best practices for their collection in a government bank of umbilical cord and placental blood. Method: this was a descriptive study, quantitative approach, performed at a government umbilical cord and placental blood bank, in two steps: 1) verification of the obstetric, neonatal and operational factors, using a specific tool for gathering data as non-participant observers; 2) definition of best practices by grouping non-conformities observed before, during and after blood collection. The data was analyzed using descriptive statistics and the following statistical software: Statistica(r) and R(r). Results: while there was a correlation with obstetrical and neonatal factors, there was a larger correlation with operational factors, resulting in the need to adjust the professional practices of the nursing staff and obstetrical team involved in collecting this type of blood. Based on these non-conformities we defined best practices for nurses before, during and after blood collection. Conclusion: the best practices defined in this study are an important management tool for the work of nurses in obtaining blood specimens of high cell quality. PMID:27556876

  11. Good Practices Addressing School Integration of Roma/Gypsy Children in Hungary

    ERIC Educational Resources Information Center

    Messing, Vera

    2008-01-01

    Our recent project has a comparative perspective: it compares selected good practices of integration of ethnic minority children among three European countries (Italy, Switzerland and Hungary). The project examines several key areas of integration: governmental policies, NGO practices and most importantly good practices that might be transferable,…

  12. 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

    ..., manufactured good, public building and public work, and steel, as used in this provision, are defined in 2 CFR... information and applicable supporting data required by 2 CFR 176.160 (c) and (d) in the request. If an... shall submit a separate cost comparison table prepared in accordance with paragraphs 2 CFR...

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

    Technology Transfer Automated Retrieval System (TEKTRAN)

    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...

  14. Educating Global Citizens: A Good "Idea" or an Organisational Practice?

    ERIC Educational Resources Information Center

    Lilley, Kathleen; Barker, Michelle; Harris, Neil

    2015-01-01

    Higher education emphasises training and skills for employment, yet while the "idea" of educating global citizens appears in university discourse, there is limited evidence demonstrating how the "idea" of the global citizen translates into practice. Recent research emphasises a desire for graduates to be local and global…

  15. Understanding and Developing Good Practice: Language Teaching in Higher Education

    ERIC Educational Resources Information Center

    Klapper, John

    2006-01-01

    This new book supports the professional development and training of Modern Languages teachers in higher education. It links insights from pedagogical and applied linguistic research to the practicalities of the undergraduate language syllabus. The aim is to interpret research for the classroom practitioner so that teaching can be based on sound…

  16. How to improve the performance of a good medical practice team: twelve techniques.

    PubMed

    Hills, Laura

    2013-01-01

    It is incredibly easy to ignore the medical practice team that is doing a good job. However, when we allow good performers to continue as they are, they probably won't improve. Their performance may even worsen. This is unfortunate because with a little bit of effort and support, good performers can often learn to excel. This article offers 12 techniques medical practice managers can use to bring their team members from good performance to excellent. It describes how to use goal-setting, work assignments, modeling, confidence building, team retreats, rewards, incentives, and reinforcement to ratchet up a good medical practice team's performance. This article also identifies the signs of medical employee mediocrity. It describes why setting higher expectations of your medical practice employees will ultimately improve their performance. Finally, this article suggests 10 practical and affordable strategies that medical practice managers can use to reinforce excellent performance in their good employees. PMID:23866656

  17. How to improve the performance of a good medical practice team: twelve techniques.

    PubMed

    Hills, Laura

    2013-01-01

    It is incredibly easy to ignore the medical practice team that is doing a good job. However, when we allow good performers to continue as they are, they probably won't improve. Their performance may even worsen. This is unfortunate because with a little bit of effort and support, good performers can often learn to excel. This article offers 12 techniques medical practice managers can use to bring their team members from good performance to excellent. It describes how to use goal-setting, work assignments, modeling, confidence building, team retreats, rewards, incentives, and reinforcement to ratchet up a good medical practice team's performance. This article also identifies the signs of medical employee mediocrity. It describes why setting higher expectations of your medical practice employees will ultimately improve their performance. Finally, this article suggests 10 practical and affordable strategies that medical practice managers can use to reinforce excellent performance in their good employees.

  18. Clinical audit: shining a light on good practice.

    PubMed

    Grainger, Angela

    2010-07-01

    Healthcare organisations undertake quality assurance to produce safe and effective patient care systems. Statutory quality assurance requirements are met through external reviews, monitoring and inspection processes, and each NHS trust must produce a corporate annual quality account. However, this can result in approaching audits as if they are 'tick-box activities'. This article discusses how organisations can avoid this trap by applying audit results to practice. PMID:20681403

  19. Setting good practices to assess the efficiency of iron fertilizers.

    PubMed

    El-Jendoubi, Hamdi; Melgar, Juan Carlos; Alvarez-Fernández, Ana; Sanz, Manuel; Abadía, Anunciación; Abadía, Javier

    2011-05-01

    The most prevalent nutritional disorder in fruit tree crops growing in calcareous soils is Fe deficiency chlorosis. Iron-deficient, chlorotic tree orchards require Fe-fertilization, since chlorosis causes decreases in tree vegetative growth as well as fruit yield and quality losses. When assessing the effectiveness of Fe-fertilizers, it is necessary to use sound practices based in the state-of-the art knowledge on the physiology and biochemistry of Fe deficiency. This review provides an overview on how to carry out the assessment of the efficiency of Fe-fertilizers, discussing common errors found in the literature, outlining adequate procedures and giving real examples of practical studies carried out in our laboratory in the past decade. The review focuses on: i) the design of Fe-fertilization experiments, discussing several issues such as the convenience of using controlled conditions or field experiments, whether fertilizer assessment experiments should mimic usual fertilization practices, as well as aspects regarding product formulations, dosages, control references and number of replicates; ii) the assessment of chlorosis recovery upon Fe-fertilization by monitoring leaf chlorophyll, and iii) the analysis of the plant responses upon Fe-fertilization, discussing the phases of leaf chlorosis recovery and the control of other leaf nutritional parameters.

  20. 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.

  1. 9 CFR 147.26 - Procedures for establishing isolation and maintaining sanitation and good management practices...

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 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... Management and Budget under control number 0579-0007)...

  2. Good Signal Detection Practices: Evidence from IMI PROTECT.

    PubMed

    Wisniewski, Antoni F Z; Bate, Andrew; Bousquet, Cedric; Brueckner, Andreas; Candore, Gianmario; Juhlin, Kristina; Macia-Martinez, Miguel A; Manlik, Katrin; Quarcoo, Naashika; Seabroke, Suzie; Slattery, Jim; Southworth, Harry; Thakrar, Bharat; Tregunno, Phil; Van Holle, Lionel; Kayser, Michael; Norén, G Niklas

    2016-06-01

    Over a period of 5 years, the Innovative Medicines Initiative PROTECT (Pharmacoepidemiological Research on Outcomes of Therapeutics by a European ConsorTium) project has addressed key research questions relevant to the science of safety signal detection. The results of studies conducted into quantitative signal detection in spontaneous reporting, clinical trial and electronic health records databases are summarised and 39 recommendations have been formulated, many based on comparative analyses across a range of databases (e.g. regulatory, pharmaceutical company). The recommendations point to pragmatic steps that those working in the pharmacovigilance community can take to improve signal detection practices, whether in a national or international agency or in a pharmaceutical company setting. PROTECT has also pointed to areas of potentially fruitful future research and some areas where further effort is likely to yield less. PMID:26951233

  3. In search of the good: narrative reasoning in clinical practice.

    PubMed

    Mattingly, C

    1998-09-01

    Based on ethnographic work among North American occupational therapists, I compare two forms of everyday clinical talk. One, "chart talk," conforms to normative conceptions of clinical rationality. The second, storytelling, permeates clinical discussions but has no formal status as a vehicle for clinical reasoning. I argue that both modes of discourse provide avenues for reasoning about clinical problems. However, these discourses construct very different clinical objects and different phenomena to reason about. Further, the clinical problems created through storytelling point toward a more radically distinct conception of rationality than the one underlying biomedicine as it is formally conceived. Clinical storytelling is more usefully understood as a mode of Aristotle's "practical rationality" than the technical rationality of modern (enlightenment) conceptions of reasoning. PMID:9746895

  4. Student Learning Community of Practice: Making Meaning of the Student Learning Imperative and Principles of Good Practice in Student Affairs

    ERIC Educational Resources Information Center

    Smith, Scott F.; Rodgers, Robert F.

    2005-01-01

    This ethnomethodological case study analysis explored and described how The Student Learning Imperative (American College Personnel Association, 1994), Principles of Good Practice for Student Affairs (American College Personnel Association & National Association of Student Personnel Administrators, 1996), and Good Practice in Student Affairs…

  5. Good practice for conducting and reporting MEG research

    PubMed Central

    Gross, Joachim; Baillet, Sylvain; Barnes, Gareth R.; Henson, Richard N.; Hillebrand, Arjan; Jensen, Ole; Jerbi, Karim; Litvak, Vladimir; Maess, Burkhard; Oostenveld, Robert; Parkkonen, Lauri; Taylor, Jason R.; van Wassenhove, Virginie; Wibral, Michael; Schoffelen, Jan-Mathijs

    2013-01-01

    Magnetoencephalographic (MEG) recordings are a rich source of information about the neural dynamics underlying cognitive processes in the brain, with excellent temporal and good spatial resolution. In recent years there have been considerable advances in MEG hardware developments and methods. Sophisticated analysis techniques are now routinely applied and continuously improved, leading to fascinating insights into the intricate dynamics of neural processes. However, the rapidly increasing level of complexity of the different steps in a MEG study make it difficult for novices, and sometimes even for experts, to stay aware of possible limitations and caveats. Furthermore, the complexity of MEG data acquisition and data analysis requires special attention when describing MEG studies in publications, in order to facilitate interpretation and reproduction of the results. This manuscript aims at making recommendations for a number of important data acquisition and data analysis steps and suggests details that should be specified in manuscripts reporting MEG studies. These recommendations will hopefully serve as guidelines that help to strengthen the position of the MEG research community within the field of neuroscience, and may foster discussion in order to further enhance the quality and impact of MEG research. PMID:23046981

  6. 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

  7. 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 leadership…

  8. 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.…

  9. Ten good reasons to practice ultrasound in critical care.

    PubMed

    Lichtenstein, Daniel; van Hooland, Simon; Elbers, Paul; Malbrain, Manu L N G

    2014-01-01

    combination with lung ultrasound, with the appearance of B-lines considered to be the endpoint for fluid therapy. An advantage of lung ultrasound is that the patient is not exposed to radiation, and so the LUCI-FLR project (LUCI favouring limitation of radiation) can be unfolded in trauma patients. Although it has been practiced for 25 years, critical care ultrasound is a relatively young but expanding discipline and can be seen as the stethoscope of the modern intensivist. In this review, the usefulness and advantages of ultrasound in the critical care setting are discussed in ten points. The emphasis is on a holistic approach, with a central role for lung ultrasound.

  10. Ten good reasons to practice ultrasound in critical care.

    PubMed

    Lichtenstein, Daniel; van Hooland, Simon; Elbers, Paul; Malbrain, Manu L N G

    2014-01-01

    combination with lung ultrasound, with the appearance of B-lines considered to be the endpoint for fluid therapy. An advantage of lung ultrasound is that the patient is not exposed to radiation, and so the LUCI-FLR project (LUCI favouring limitation of radiation) can be unfolded in trauma patients. Although it has been practiced for 25 years, critical care ultrasound is a relatively young but expanding discipline and can be seen as the stethoscope of the modern intensivist. In this review, the usefulness and advantages of ultrasound in the critical care setting are discussed in ten points. The emphasis is on a holistic approach, with a central role for lung ultrasound. PMID:25432552

  11. Modeling good research practices--overview: a report of the ISPOR-SMDM Modeling Good Research Practices Task Force--1.

    PubMed

    Caro, J Jaime; Briggs, Andrew H; Siebert, Uwe; Kuntz, Karen M

    2012-01-01

    Models--mathematical frameworks that facilitate estimation of the consequences of health care decisions--have become essential tools for health technology assessment. Evolution of the methods since the first ISPOR Modeling Task Force reported in 2003 has led to a new Task Force, jointly convened with the Society for Medical Decision Making, and this series of seven articles presents the updated recommendations for best practices in conceptualizing models; implementing state-transition approaches, discrete event simulations, or dynamic transmission models; and dealing with uncertainty and validating and reporting models transparently. This overview article introduces the work of the Task Force, provides all the recommendations, and discusses some quandaries that require further elucidation. The audience for these articles includes those who build models, stakeholders who utilize their results, and, indeed, anyone concerned with the use of models to support decision making. PMID:22999128

  12. Modeling good research practices--overview: a report of the ISPOR-SMDM Modeling Good Research Practices Task Force-1.

    PubMed

    Caro, J Jaime; Briggs, Andrew H; Siebert, Uwe; Kuntz, Karen M

    2012-01-01

    Models-mathematical frameworks that facilitate estimation of the consequences of health care decisions-have become essential tools for health technology assessment. Evolution of the methods since the first ISPOR modeling task force reported in 2003 has led to a new task force, jointly convened with the Society for Medical Decision Making, and this series of seven papers presents the updated recommendations for best practices in conceptualizing models; implementing state-transition approaches, discrete event simulations, or dynamic transmission models; dealing with uncertainty; and validating and reporting models transparently. This overview introduces the work of the task force, provides all the recommendations, and discusses some quandaries that require further elucidation. The audience for these papers includes those who build models, stakeholders who utilize their results, and, indeed, anyone concerned with the use of models to support decision making. PMID:22990082

  13. Modeling good research practices--overview: a report of the ISPOR-SMDM Modeling Good Research Practices Task Force--1.

    PubMed

    Caro, J Jaime; Briggs, Andrew H; Siebert, Uwe; Kuntz, Karen M

    2012-01-01

    Models--mathematical frameworks that facilitate estimation of the consequences of health care decisions--have become essential tools for health technology assessment. Evolution of the methods since the first ISPOR Modeling Task Force reported in 2003 has led to a new Task Force, jointly convened with the Society for Medical Decision Making, and this series of seven articles presents the updated recommendations for best practices in conceptualizing models; implementing state-transition approaches, discrete event simulations, or dynamic transmission models; and dealing with uncertainty and validating and reporting models transparently. This overview article introduces the work of the Task Force, provides all the recommendations, and discusses some quandaries that require further elucidation. The audience for these articles includes those who build models, stakeholders who utilize their results, and, indeed, anyone concerned with the use of models to support decision making.

  14. Modeling good research practices--overview: a report of the ISPOR-SMDM Modeling Good Research Practices Task Force-1.

    PubMed

    Caro, J Jaime; Briggs, Andrew H; Siebert, Uwe; Kuntz, Karen M

    2012-01-01

    Models-mathematical frameworks that facilitate estimation of the consequences of health care decisions-have become essential tools for health technology assessment. Evolution of the methods since the first ISPOR modeling task force reported in 2003 has led to a new task force, jointly convened with the Society for Medical Decision Making, and this series of seven papers presents the updated recommendations for best practices in conceptualizing models; implementing state-transition approaches, discrete event simulations, or dynamic transmission models; dealing with uncertainty; and validating and reporting models transparently. This overview introduces the work of the task force, provides all the recommendations, and discusses some quandaries that require further elucidation. The audience for these papers includes those who build models, stakeholders who utilize their results, and, indeed, anyone concerned with the use of models to support decision making.

  15. 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

    ... 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...

  16. 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

    ... 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...

  17. 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...

  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)...

  19. 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

    ... 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...

  20. 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...

  1. 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

  2. Impact of advanced manufacturing technology on prosthetic and orthotic practice.

    PubMed

    Jones, D

    1988-04-01

    Radical changes in the technology applied to prosthetics and orthotics are being proposed. This paper attempts to define the scope and character of advanced manufacturing technology and examines the rehabilitation problems which are or could be tackled. Lower-limb prosthetics has been the major area under investigation so far, but orthopaedic footwear, spinal orthotics and custom seating for the disabled have also been investigated using similar technological approaches. The whole process of patient measurement, device design, and component manufacture is conceived as an integrated system relying upon shape or tissue property sensing, computer based device design and computer-numerically-controlled or robot manufacturing processes. The aim is to retain flexibility for custom design which is necessary to provide for individual patients, and yet improve the rapidity and precision of overall device manufacture and service delivery.

  3. 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.

  4. Good ergonomics and team diversity reduce absenteeism and errors in car manufacturing.

    PubMed

    Fritzsche, Lars; Wegge, Jürgen; Schmauder, Martin; Kliegel, Matthias; Schmidt, Klaus-Helmut

    2014-01-01

    Prior research suggests that ergonomics work design and mixed teams (in age and gender) may compensate declines in certain abilities of ageing employees. This study investigates simultaneous effects of both team level factors on absenteeism and performance (error rates) over one year in a sample of 56 car assembly teams (N = 623). Results show that age was related to prolonged absenteeism and more mistakes in work planning, but not to overall performance. In comparison, high-physical workload was strongly associated with longer absenteeism and increased error rates. Furthermore, controlling for physical workload, age diversity was related to shorter absenteeism, and the presence of females in the team was associated with shorter absenteeism and better performance. In summary, this study suggests that both ergonomics work design and mixed team composition may compensate age-related productivity risks in manufacturing by maintaining the work ability of older employees and improving job quality.

  5. Good ergonomics and team diversity reduce absenteeism and errors in car manufacturing.

    PubMed

    Fritzsche, Lars; Wegge, Jürgen; Schmauder, Martin; Kliegel, Matthias; Schmidt, Klaus-Helmut

    2014-01-01

    Prior research suggests that ergonomics work design and mixed teams (in age and gender) may compensate declines in certain abilities of ageing employees. This study investigates simultaneous effects of both team level factors on absenteeism and performance (error rates) over one year in a sample of 56 car assembly teams (N = 623). Results show that age was related to prolonged absenteeism and more mistakes in work planning, but not to overall performance. In comparison, high-physical workload was strongly associated with longer absenteeism and increased error rates. Furthermore, controlling for physical workload, age diversity was related to shorter absenteeism, and the presence of females in the team was associated with shorter absenteeism and better performance. In summary, this study suggests that both ergonomics work design and mixed team composition may compensate age-related productivity risks in manufacturing by maintaining the work ability of older employees and improving job quality. PMID:24428619

  6. 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

    .... Lecture examples would include a GLP Refresher, Good Documentation practices, Internal GLP Audits... conducting studies in BSL-4 laboratories. An entire half-day will be devoted to teaching what is...

  7. A Research Informed Vision of Good Practice in Multicultural Teacher Education: Design Principles.

    ERIC Educational Resources Information Center

    Zeichner, Kenneth M.; Grant, Carl; Gay, Geneva; Gillette, Maureen; Valli, Linda; Villegas, Ana Maria

    1998-01-01

    Presents 14 design principles that explain good practice in multicultural preservice teacher education. The principles fall under the three main categories of (1) institutional and programmatic principles, (2) personnel principles, and (3) curriculum and instruction principles. (SM)

  8. Best Practices in School-to-Careers: The Manufacturing Industry.

    ERIC Educational Resources Information Center

    Manufacturing Industries Careers Alliance, Washington, DC.

    This booklet, which is part of a series demonstrating the scope of employer involvement in school-to-careers, highlights the efforts of six manufacturing employers and three "intermediary" organizations connecting workplace experiences to classroom learning for secondary education students. The introduction presents a series overview and lists the…

  9. 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. PMID:22475948

  10. 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…

  11. 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. PMID:17867246

  12. 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... Sanitation Procedures § 147.26 Procedures for establishing isolation and maintaining sanitation and good... are required for participation under the U.S. Sanitation Monitored, U.S. M. Gallisepticum Clean,...

  13. Affinity Disciplines and the Use of Principles of Good Practice for Undergraduate Education.

    ERIC Educational Resources Information Center

    Braxton, John M.; Olsen, Deborah; Simmons, Ada

    1998-01-01

    Academic disciplines with soft paradigmatic development have greater affinity for practices designed to improve undergraduate education than do hard paradigmatic disciplines. A study extends this hypothesis to the seven principles of good practice, garnering empirical support for four principles: encouragement of faculty-student contact;…

  14. The Seven Principles of Good Practice: A Framework for Evaluating On-Line Teaching

    ERIC Educational Resources Information Center

    Bangert, Arthur W.

    2004-01-01

    Traditionally, campus-based courses rely on student evaluations to provide instructors with feedback about their teaching effectiveness. However, current instructor evaluation instruments do not tap the essential teaching practices recommended for effective on-line teaching. This exploratory study used the Seven Principles of Good Practice of…

  15. 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…

  16. 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…

  17. 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,…

  18. 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…

  19. Good Cascade Impactor Practice (GCIP) and considerations for "in-use" specifications.

    PubMed

    Nichols, S C; Mitchell, J P; Shelton, C M; Roberts, D L

    2013-03-01

    The multi-stage cascade impactor (CI) is widely used to determine aerodynamic particle size distributions (APSDs) of orally inhaled products. Its size-fractionating capability depends primarily on the size of nozzles of each stage. Good Cascade Impactor Practice (GCIP) requires that these critical dimensions are linked to the accuracy of the APSD measurement based on the aerodynamic diameter size scale. Effective diameter (Deff) is the critical dimension describing any nozzle array, as it is directly related to stage cut-point size (d50). d50 can in turn be determined by calibration using particles of known aerodynamic diameter, providing traceability to the international length standard. Movements in Deff within manufacturer tolerances for compendial CIs result in the worst case in shifts in d50 of <±10%. Stage mensuration therefore provides satisfactory control of measurement accuracy. The accurate relationship of Deff to d50 requires the CI system to be leak-free, which can be checked by sealing the apparatus at the entry to the induction port and isolating it from the vacuum source and measuring the rate of pressure rise before each use. Mensuration takes place on an infrequent basis compared with the typical interval between individual APSD determinations. Measurement of stage flow resistance (pressure drop; ΔPstage) could enable the user to know that the CI stages are fit for use before every APSD measurement, by yielding an accurate measure of Deff. However, more data are needed to assess the effects of wear and blockage before this approach can be advocated as part of GCIP.

  20. 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.

  1. 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...

  2. 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,...

  3. 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,...

  4. 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...

  5. 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...

  6. 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...

  7. 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...

  8. 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

    ... amount or redistribute budgeted funds by at least the differential established in 2 CFR 176.110(a). (3..., 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...

  9. 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,...

  10. 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,...

  11. Research and implementation of good agricultural practice for traditional Chinese medicinal materials in Jilin Province, China

    PubMed Central

    Li, Changtian; Yan, Zhengfei; Zhang, Lianxue; Li, Yu

    2014-01-01

    Jilin Province is one of the principal production bases of traditional Chinese medicine (TCM) in China with its typical preponderance in TCM resources, research and development power, and industrialization capacity. The province has 2,790 species of TCM materials in total. Over 20% of the TCM materials in common use are from Jilin Province. The province has established 36 good agricultural practice bases for 22 typical TCMs. The overall situation, in terms of collection, processing, and preparation, and the implementation of good agricultural practice of TCM materials in Jilin Province are summarized. PMID:25379000

  12. Development of FeSiBNbCu Nanocrystalline Soft Magnetic Alloys with High B s and Good Manufacturability

    NASA Astrophysics Data System (ADS)

    Wan, Fangpei; He, Aina; Zhang, Jianhua; Song, Jiancheng; Wang, Anding; Chang, Chuntao; Wang, Xinmin

    2016-10-01

    In order to develop Fe-based nanocrystalline soft magnetic alloys with high saturation magnetic flux density ( B s) and good manufacturability, the effect of the Nb content on the thermal stability, microstructural evolution and soft magnetic properties of Fe78- x Si13B8Nb x Cu1 ( x = 0, 1, 2 and 3) alloys were investigated. It is found that proper Nb addition is effective in widening the optimum annealing temperature range and refining the α-Fe grain in addition to enhancing the soft magnetic properties. For the representative Fe76 Si13B8Nb2Cu1 alloy, the effective annealing time can be over 60 min in the optimal temperature range of 500-600°C. FeSiBNbCu nanocrystalline soft magnetic alloys with desirable soft magnetic properties including high B s of 1.39 T, low coercivity ( H c) of 1.5 A/m and high effective permeability ( μ e) of 21,500 at 1 kHz have been developed. The enhanced soft magnetic performance and manufacturability of the FeSiBNbCu nanocrystalline alloys are attributed to the high activated energy for the precipitation of α-Fe(Si) and the second phase. These alloys with excellent performance have promising applications in electromagnetic fields like inductors.

  13. Development of FeSiBNbCu Nanocrystalline Soft Magnetic Alloys with High B s and Good Manufacturability

    NASA Astrophysics Data System (ADS)

    Wan, Fangpei; He, Aina; Zhang, Jianhua; Song, Jiancheng; Wang, Anding; Chang, Chuntao; Wang, Xinmin

    2016-06-01

    In order to develop Fe-based nanocrystalline soft magnetic alloys with high saturation magnetic flux density (B s) and good manufacturability, the effect of the Nb content on the thermal stability, microstructural evolution and soft magnetic properties of Fe78-x Si13B8Nb x Cu1 (x = 0, 1, 2 and 3) alloys were investigated. It is found that proper Nb addition is effective in widening the optimum annealing temperature range and refining the α-Fe grain in addition to enhancing the soft magnetic properties. For the representative Fe76 Si13B8Nb2Cu1 alloy, the effective annealing time can be over 60 min in the optimal temperature range of 500-600°C. FeSiBNbCu nanocrystalline soft magnetic alloys with desirable soft magnetic properties including high B s of 1.39 T, low coercivity (H c) of 1.5 A/m and high effective permeability (μ e) of 21,500 at 1 kHz have been developed. The enhanced soft magnetic performance and manufacturability of the FeSiBNbCu nanocrystalline alloys are attributed to the high activated energy for the precipitation of α-Fe(Si) and the second phase. These alloys with excellent performance have promising applications in electromagnetic fields like inductors.

  14. 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.

  15. 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. PMID:27021745

  16. 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.

  17. 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…

  18. Formative Assessment and Self-Regulated Learning: A Model and Seven Principles of Good Feedback Practice

    ERIC Educational Resources Information Center

    Nicol, David J.; Macfarlane-Dick, Debra

    2006-01-01

    The research on formative assessment and feedback is reinterpreted to show how these processes can help students take control of their own learning, i.e. become self-regulated learners. This reformulation is used to identify seven principles of good feedback practice that support self-regulation. A key argument is that students are already…

  19. 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…

  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. 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…

  2. Gypsy, Roma and Traveller Pupils in Schools in the UK: Inclusion and "Good Practice"

    ERIC Educational Resources Information Center

    Bhopal, Kalwant; Myers, Martin

    2009-01-01

    This paper examines inclusionary processes and examples of "good practice" in primary and secondary schools for Gypsy, Roma and Traveller pupils in one inner London Borough in the UK. It will explore the role of the Traveller Education Service (TES) and argue that the support provided by the TES to schools is essential for the development of "good…

  3. 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…

  4. 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 Lifelong Learning…

  5. 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…

  6. 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) Research…

  7. Good Clinical Practice Guidance and Pragmatic Clinical Trials: Balancing the Best of Both Worlds.

    PubMed

    Mentz, Robert J; Hernandez, Adrian F; Berdan, Lisa G; Rorick, Tyrus; O'Brien, Emily C; Ibarra, Jenny C; Curtis, Lesley H; Peterson, Eric D

    2016-03-01

    Randomized, clinical trials are commonly regarded as the highest level of evidence to support clinical decisions. Good Clinical Practice guidelines have been constructed to provide an ethical and scientific quality standard for trials that involve human subjects in a manner aligned with the Declaration of Helsinki. Originally designed to provide a unified standard of trial data to support submission to regulatory authorities, the principles may also be applied to other studies of human subjects. Although the application of Good Clinical Practice principles generally led to improvements in the quality and consistency of trial operations, these principles have also contributed to increasing trial complexity and costs. Alternatively, the growing availability of electronic health record data has facilitated the possibility for streamlined pragmatic clinical trials. The central tenets of Good Clinical Practice and pragmatic clinical trials represent potential tensions in trial design (stringent quality and highly efficient operations). In the present article, we highlight potential areas of discordance between Good Clinical Practice guidelines and the principles of pragmatic clinical trials and suggest strategies to streamline study conduct in an ethical manner to optimally perform clinical trials in the electronic age.

  8. 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…

  9. 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…

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

    SciTech Connect

    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 TS 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.

  11. Establishing Good Computer Modelling Practice (GCMP) in the Prediction of Chemical Toxicity.

    PubMed

    Judson, Philip N; Barber, Christopher; Canipa, Steven J; Poignant, Géraldine; Williams, Richard

    2015-05-01

    This paper suggests guidelines for good computer modelling practice (GCMP) when predicting chemical toxicity, with similar purposes to those for Good Laboratory Practice (GLP). The purpose of GCMP is not to specify what should be delivered with models or predictions but to set out what must be done to ensure that work can be audited, on site, in a way analogous to the auditing of studies conforming to GLP; it is intended to confirm that work has been done properly, as distinct from providing advice on how to do it. Comments are made on the guidelines and how they might be followed, based on practical experience with the implementation of such a scheme in the development of knowledge-based and quantitative structure activity relationship models. It is hoped that publication of this paper will encourage wider discussion of the subject leading to adoption of measures to ensure the trustworthiness of computer modelling work that is carried out in connection with regulatory submissions.

  12. 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. PMID:27378375

  13. 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.

  14. 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…

  15. 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.

  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. 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.

  18. 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. PMID:26259067

  19. 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.

  20. British Fertility Society Policy and Practice Committee: adjuvants in IVF: evidence for good clinical practice.

    PubMed

    Nardo, Luciano G; El-Toukhy, Tarek; Stewart, Jane; Balen, Adam H; Potdar, Neelam

    2015-03-01

    Optimisation of the environment favourable for satisfactory ovarian response to stimulation and successful embryo implantation remains at the core of assisted conception programmes. The evidence base for the routine use of different adjuvants, alone or in combination, for women undergoing their first in vitro fertilisation (IVF) treatment cycle and for those with poor prognosis is inadequate. The aim of this document is to update the last review of the available literature carried out by the British Fertility Society Policy and Practice Committee (BFS P&P) published in 2009 and to provide fertility professionals with evidence-based guidance and recommendations regarding the use of immunotherapy, vasodilators, uterine relaxants, aspirin, heparin, growth hormone, dehydroepiandrosterone, oestrogen and metformin as adjuvants in IVF. Unfortunately despite the lapse of 5 years since the last publication, there is still a lack of robust evidence for most of the adjuvants searched and large well-designed randomised controlled trials are still needed. One possible exception is metformin, which seems to have a positive effect in women with polycystic ovary syndrome undergoing IVF. Patients who are given other adjuvants on an empirical basis should always be informed of the lack of evidence and the potential side effects. PMID:25531921

  1. 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.

  2. 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…

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

    SciTech Connect

    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 required reading program to promote safe and efficient operations.

  4. Guide to good practices for control of on-shift training

    SciTech Connect

    1998-12-01

    This Guide to Good Practices is written to enhance understanding of, and provide direction for, Control of On-Shift Training, Chapter 5 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 on-shift training programs. ``Control of On-Shift Training`` is an element of an effective Conduct of Operations program. The complexity and array of activities performed in DOE facilities dictate the necessary for a coordinated on-shift training program to meet the continuous demand for skilled, well-trained personnel to promote safe and efficient operations.

  5. Ethics meetings in support of good nursing care: some practice-based thoughts.

    PubMed

    Dierckx de Casterlé, Bernadette; Meulenbergs, Tom; van de Vijver, Lut; Tanghe, Anne; Gastmans, Chris

    2002-11-01

    The purpose of this article is to clarify both the role of nurses in ethics meetings and the way in which ethics meetings can function as a catalyst for good nursing care. The thoughts presented are practice based; they arose from our practical experiences as nurses and ethicists with ethics meetings in health care organizations in Belgium. Our reflections are written from the perspective of the nurse in the field who is participating in (inter)professional ethical dialogue. First, the difficulties that nurses experience while participating in ethics meetings are described. Then the possibilities for support of nurses in their ethical responsibility are explored. PMID:12449998

  6. Importance of good manufacturing practices in microbiological monitoring in processing human tissues for transplant.

    PubMed

    Pianigiani, Elisa; Ierardi, Francesca; Fimiani, Michele

    2013-12-01

    Skin allografts represent an important therapeutic resource in the treatment of severe skin loss. The risk associated with application of processed tissues in humans is very low, however, human material always carries the risk of disease transmission. To minimise the risk of contamination of grafts, processing is carried out in clean rooms where air quality is monitored. Procedures and quality control tests are performed to standardise the production process and to guarantee the final product for human use. Since we only validate and distribute aseptic tissues, we conducted a study to determine what type of quality controls for skin processing are the most suitable for detecting processing errors and intercurrent contamination, and for faithfully mapping the process without unduly increasing production costs. Two different methods for quality control were statistically compared using the Fisher exact test. On the basis of the current study we selected our quality control procedure based on pre- and post-processing tissue controls, operator and environmental controls. Evaluation of the predictability of our control methods showed that tissue control was the most reliable method of revealing microbial contamination of grafts. We obtained 100 % sensitivity by doubling tissue controls, while maintaining high specificity (77 %). PMID:23271587

  7. Good manufacturing practice for modelling air pollution: Quality criteria for computer models to calculate air pollution

    NASA Astrophysics Data System (ADS)

    Dekker, C. M.; Sliggers, C. J.

    To spur on quality assurance for models that calculate air pollution, quality criteria for such models have been formulated. By satisfying these criteria the developers of these models and producers of the software packages in this field can assure and account for the quality of their products. In this way critics and users of such (computer) models can gain a clear understanding of the quality of the model. Quality criteria have been formulated for the development of mathematical models, for their programming—including user-friendliness, and for the after-sales service, which is part of the distribution of such software packages. The criteria have been introduced into national and international frameworks to obtain standardization.

  8. Imaging techniques applied to quality control of civil manufactured goods obtained starting from ready-to-use mixtures

    NASA Astrophysics Data System (ADS)

    Bonifazi, Giuseppe; Castaldi, Federica

    2003-05-01

    Concrete materials obtained from the utilization of pre-mixed and ready to use products (central mix-concrete) are more and more used. They represent a big portion of the civil construction market. Such products are used at different scale, ranging from small scale works, as those commonly realized inside and house, an apartment, etc. or at big civil or industrial scale works. In both cases the problem to control the mixtures and the final work is usually realized through the analysis of properly collected samples. Through appropriate sampling it can be derived objective parameters, as size class distribution and composition of the constituting particulate matter, or mechanical characteristics of the sample itself. An important parameter not considered by the previous mentioned approach is "segregation", that is the possibility that some particulate materials migrate preferentially in some zones of the mixtures and/or of the final product. Such a behavior dramatically influences the quality of the product and of the final manufactured good. Actually this behavior is only studied adopting a human based visual approach. Not repeatable analytical procedures or quantitative data processing exist. In this paper a procedure fully based on image processing techniques is described and applied. Results are presented and analyzed with reference to industrial products. A comparison is also made between the new proposed digital imaging based techniques and the analyses usually carried out at industrial laboratory scale for standard quality control.

  9. Guide to good practices for the development of test items. DOE guideline

    SciTech Connect

    Not Available

    1992-07-01

    The purpose of the Department of Energy (DOE) guide to Good Practices for the Development of Test Items is to provide DOE contractor organizations with information that can be used to modify existing programs with or to develop new programs. DOE contractors should not feel obligated to adopt all of this guide. Rather, they can use the information in this guide to develop programs that apply to their facility. This guide, used in conjunction with DOE Guide to Good Practices for the Design, Development, and Implementation of Examinations, can be used as an aid to provide a framework for the systematic development of valid and reliable examinations. In addition, detailed examples of short answer, multiple-choice, and essay test-item formats are intended to aid in developing effective test items.

  10. Guide to good practices for training and qualification of instructors. DOE handbook

    SciTech Connect

    1996-03-01

    Purpose of this guide is to provide contractor training organizations with information that can be used to verify the adquacy and/or modify existing instructor training programs, or to develop new training programs. It contains good practices for the training and qualification of technical instructors and instructional technologists at DOE reactor and non-reactor nuclear facilities. It addresses the content of initial and continuing instructor training programs, evaluation of instructor training programs, and maintenance of instructor training records.

  11. Teaching epidemiology using WebCT: application of the seven principles of good practice.

    PubMed

    Suen, Lorna

    2005-03-01

    Web-based teaching was strategically used to supplement classroom instruction in an epidemiology course for RN-to-BSN students. This article investigates how the "Seven Principles for Good Practice" were applied as a guide when teaching this online course and discusses this innovative teaching strategy with the aim of advancing pedagogical strategies from the traditional, teacher-centered paradigm to an active, learner-centered paradigm.

  12. 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

  13. A systematic approach to initial data analysis is good research practice.

    PubMed

    Huebner, Marianne; Vach, Werner; le Cessie, Saskia

    2016-01-01

    Initial data analysis is conducted independently of the analysis needed to address the research questions. Shortcomings in these first steps may result in inappropriate statistical methods or incorrect conclusions. We outline a framework for initial data analysis and illustrate the impact of initial data analysis on research studies. Examples of reporting of initial data analysis in publications are given. A systematic and careful approach to initial data analysis is needed as good research practice.

  14. 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. PMID:27613211

  15. 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.

  16. High ear-piercing: an increasingly popular procedure with serious complications. Is good clinical practice exercised?

    PubMed

    Lyons, Marie; Stephens, Joanna; Wasson, Joseph; DeZoysa, Nilantha; Vlastarakos, Petros V

    2012-03-01

    This study aimed to explore the current practice of performing high ear-piercing regarding consent protocols, and methods of practice using questionnaire-based survey in Hertfordshire and North London. Recommendations for good clinical practice are also made. 100 establishments performing ear piercing were identified. A 16-item questionnaire on techniques used, methods of high-ear piercing, methods of sterilization, consent issues and aftercare was completed. Seventy-six establishments agreed to participate. All practitioners prepared the skin before piercing. 58 (76%) used a needle for piercing, 11 (15%) used a spring-loaded gun and seven (9%) used both. 97% of the practitioners obtained written consent before proceeding. 9 (12%) had a lower age limit of 16 years and three (4%) of 18 years. 27 piercers (36%) provided an aftercare leaflet, 41 (54%) warned the patients about risks of infection, 16 (21%) warned about cosmetic deformity and 1 (1%) specifically mentioned cauliflower ear. Results indicated that high ear piercing is an invasive procedure with a significant risk of complications leading to cosmetic deformity. Establishments should be required to counsel patients properly about the risks and potential complications of the procedure. A code of practice should be drawn up with a minimum age for piercing, requirement for proper consent, excellent hygiene and good information for postoperative care.

  17. 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...

  18. 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.

  19. 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. PMID:26555528

  20. 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

  1. 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

  2. Health physics manual of good practices for plutonium facilities. [Contains glossary

    SciTech Connect

    Brackenbush, L.W.; Heid, K.R.; Herrington, W.N.; Kenoyer, J.L.; Munson, L.F.; Munson, L.H.; Selby, J.M.; Soldat, K.L.; Stoetzel, G.A.; Traub, R.J.

    1988-05-01

    This manual consists of six sections: Properties of Plutonium, Siting of Plutonium Facilities, Facility Design, Radiation Protection, Emergency Preparedness, and Decontamination and Decommissioning. While not the final authority, the manual is an assemblage of information, rules of thumb, regulations, and good practices to assist those who are intimately involved in plutonium operations. An in-depth understanding of the nuclear, physical, chemical, and biological properties of plutonium is important in establishing a viable radiation protection and control program at a plutonium facility. These properties of plutonium provide the basis and perspective necessary for appreciating the quality of control needed in handling and processing the material. Guidance in selecting the location of a new plutonium facility may not be directly useful to most readers. However, it provides a perspective for the development and implementation of the environmental surveillance program and the in-plant controls required to ensure that the facility is and remains a good neighbor. The criteria, guidance, and good practices for the design of a plutonium facility are also applicable to the operation and modification of existing facilities. The design activity provides many opportunities for implementation of features to promote more effective protection and control. The application of ''as low as reasonably achievable'' (ALARA) principles and optimization analyses are generally most cost-effective during the design phase. 335 refs., 8 figs., 20 tabs.

  3. 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.

  4. 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

    ... foreign iron, steel, and/or manufactured goods not listed by the Federal Government at 2 CFR 176.140(b)(2... building and public work, and steel, as used in this notice, are defined in the 2 CFR 176.140. (b) Requests... and applicable supporting data required by paragraphs at 2 CFR 176.140(c) and (d) in the request....

  5. 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

    ... work, and steel, as used in this notice, are defined in the 2 CFR 176.140. (b) Requests for... applicable supporting data required by paragraphs at 2 CFR 176.140(c) and (d) in the request. If an applicant..., and/or manufactured goods not listed by the Federal Government at 2 CFR 176.140(b)(2), the...

  6. 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

    ... amount or redistribute budgeted funds by at least the differential established in 2 CFR 176.110(a). (3..., 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,...

  7. 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

    ... amount or redistribute budgeted funds by at least the differential established in 2 CFR 176.110(a). (3..., 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,...

  8. 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

    ... work, and steel, as used in this notice, are defined in the 2 CFR 176.140. (b) Requests for... applicable supporting data required by paragraphs at 2 CFR 176.140(c) and (d) in the request. If an applicant..., and/or manufactured goods not listed by the Federal Government at 2 CFR 176.140(b)(2), the...

  9. Guideline to good practices for types of maintenance activities at DOE nuclear facilities

    SciTech Connect

    Not Available

    1993-03-01

    The purpose of the Guideline to Good Practices for Types of Maintenance at DOE Nuclear Facilities is to provide contractor maintenance organizations with information that may be used for the development and implementation of a properly balanced corrective, preventive and predictive maintenance program at DOE nuclear facilities. This document is intended to be an example guideline for the implementation of DOE Order 4330.4A, Maintenance Management Program, Chapter II, Element 4. DOE contractors should not feel obligated to adopt all parts of this guide. Rather, they should use the information contained herein as a guide for developing maintenance programs that are applicable to their facility.

  10. Developing a Framework for Evaluating Ethical Outcomes of Good Participatory Practices in TB Clinical Drug Trials.

    PubMed

    MacQueen, Kathleen M; Eley, Natalie T; Frick, Mike; Mingote, Laia Ruiz; Chou, Alicia; Seidel, Stephanie S; Hannah, Stacey; Hamilton, Carol

    2016-07-01

    Good Participatory Practice Guidelines for TB Drug Trials (GPP-TB) were issued in 2012, based on similar guidelines for HIV prevention and reflecting growing acceptance of the importance of community engagement and participatory strategies in clinical research. Though the need for such strategies is clear, evaluation of the benefits and burdens are needed. Working with a diverse group of global TB stakeholders including advocates, scientists, and ethicists, we used a Theory of Change approach to develop an evaluation framework for GPP-TB that includes a clearly defined ethical goal, a set of powerful strategies derived from GPP-TB practices for achieving the goal, and outcomes connecting strategies to goal. The framework is a first step in systematically evaluating participatory research in clinical trials. PMID:27368311

  11. Guide to good practices for notifications and investigation of abnormal events

    SciTech Connect

    Not Available

    1993-06-01

    This Guide to Good Practices is written to enhance understanding of, and provide direction for, Notifications, Chapter VII, and Investigation of Abnormal Events, Chapter VI, 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 notifications and investigation of abnormal events. Contractors are advised to adopt procedures that meet the intent of DOE Order 5480.19. ``Notifications`` and ``Investigation of Abnormal Events`` are elements of an effective Conduct of Operations program. The complexity and array of activities performed in DOE facilities dictate the necessity for a coordinated notifications program and a consistent method for investigating abnormal events to promote safe and efficient operations.

  12. Guide to good practices for control of equipment and system status

    SciTech Connect

    1998-12-01

    This Guide to Good Practices is written to enhance understanding of, and provide direction for, Control of Equipment and System Status, Chapter VIII 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 equipment and system status control programs. Contractors are advised to adopt procedures that meet the intent of DOE Order 5480.19. Control of Equipment and System Status is an element of an effective Conduct of Operations program. The complexity and array of activities performed in DOE facilities dictate the need for a formal status control program to promote safe and efficient operations.

  13. Guide to good practices for notifications and investigation of abnormal events

    SciTech Connect

    1998-12-01

    This Guide to Good Practices is written to enhance understanding of, and provide direction for, Notifications, Chapter VII, and Investigation of Abnormal Events, Chapter VI, 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 notifications and investigation of abnormal events. Contractors are advised to adopt procedures that meet the intent of DOE Order 5480.19. Notifications and Investigation of Abnormal Events are elements of an effective Conduct of Operations program. The complexity and array of activities performed in DOE facilities dictate the necessity for a coordinated notifications program and a consistent method for investigating abnormal events to promote safe and efficient operations.

  14. Developing a Framework for Evaluating Ethical Outcomes of Good Participatory Practices in TB Clinical Drug Trials.

    PubMed

    MacQueen, Kathleen M; Eley, Natalie T; Frick, Mike; Mingote, Laia Ruiz; Chou, Alicia; Seidel, Stephanie S; Hannah, Stacey; Hamilton, Carol

    2016-07-01

    Good Participatory Practice Guidelines for TB Drug Trials (GPP-TB) were issued in 2012, based on similar guidelines for HIV prevention and reflecting growing acceptance of the importance of community engagement and participatory strategies in clinical research. Though the need for such strategies is clear, evaluation of the benefits and burdens are needed. Working with a diverse group of global TB stakeholders including advocates, scientists, and ethicists, we used a Theory of Change approach to develop an evaluation framework for GPP-TB that includes a clearly defined ethical goal, a set of powerful strategies derived from GPP-TB practices for achieving the goal, and outcomes connecting strategies to goal. The framework is a first step in systematically evaluating participatory research in clinical trials.

  15. Implementation of VOC source reduction practices in a manufactured house and in school classrooms

    SciTech Connect

    Hodgson, A.T.; Apte, M.G.; Shendell, D.G.; Beal, D.; McIlvaine, J.E.R.

    2002-01-01

    Detailed studies of a new manufactured house and four new industrialized relocatable school classrooms were conducted to determine the emission sources of formaldehyde and other VOCs and to identify and implement source reduction practices. Procedures were developed to generate VOC emission factors that allowed reasonably accurate predictions of indoor air VOC concentrations. Based on the identified sources of formaldehyde and other aldehydes, practices were developed to reduce the concentrations of these compounds in new house construction. An alternate ceiling panel reduced formaldehyde concentrations in the classrooms. Overall, the classrooms had relatively low VOC concentrations.

  16. Environmental monitoring programs vs Good Laboratory Practice (GLP) programs: differences and similarities.

    PubMed

    Bentley, R E

    1995-12-01

    Environmental monitoring and Good Laboratory Practice programs are similar when looked at empirically. Both address quality issues, human or environmental safety, and have set procedures to assure the concomitant results. However, when compared at the operational level, they can be best described as very different. Good Laboratory Practice programs deal basically with two governmental agencies and their divisions- the Environmental Protection Agency and Food and Drug Administration. These are administered from the federal level involving no state resources. These programs are objective driven with the procedures being defined in study plans, protocols, and standard operating procedures. The environmental monitoring testing programs deal with a profusion of federal legislation including CERCLA (also known as CLP), RCRA, CWA, CAA, SDWA, NPDES and others. These acts require analysis by specific procedures mandated by the statutes. States operate many of these programs and have been given the authority by the federal government. Many of the states require separate certifications to conduct these analyses. Environmental monitoring testing laboratories often must acquire multiple state certifications to participate in multiple state programs. This is not cost effective and often leads to conflicting requirements. Much of the direction for having a national certification program comes from problems associated with these state-operated programs.

  17. Irrigation water quality and the benefits of implementing good agricultural practices during tomato (Lycopersicum esculentum) production.

    PubMed

    Estrada-Acosta, M; Jiménez, M; Chaidez, C; León-Félix, J; Castro-Del Campo, N

    2014-07-01

    The implementation of good agricultural practices (GAP) from irrigation water to the tomato packaging process enhances the safety of fresh produce and its value throughout the food chain. The aim of the present study was to show that fresh produce farms that apply and enforce GAP could reduce the presence of Salmonella in finished produce. Samples were collected biweekly from six packing houses from the central region of Sinaloa, México, for the isolation of Salmonella spp by the ISO 6579:2002 method, and the isolated strains were serotyped and genotyped by the Kauffmman-White scheme and pulsed field gel electrophoresis (PFGE), respectively. Salmonella strains were detected in 13 (36.1 %) irrigation water samples, while only two tomato samples were positive (5.5 %). Eight different serotypes were identified in irrigation water, and Salmonella Oranienburg (34 %) was the most prevalent; however, only Salmonella Agona and Salmonella Weltevreden were present on tomatoes. Salmonella Oranienburg was the most widely dispersed and variable serotype, with 10 different PFGE profiles. Salmonella Weltevreden was isolated from both types of samples, albeit with distinct genetic profiles, implying that the sources of contamination differ. These results confirm the utility of implementing good agricultural practices to reduce Salmonella contamination in irrigation water and the packaging process. PMID:24682661

  18. Environmental monitoring programs vs Good Laboratory Practice (GLP) programs: differences and similarities.

    PubMed

    Bentley, R E

    1995-12-01

    Environmental monitoring and Good Laboratory Practice programs are similar when looked at empirically. Both address quality issues, human or environmental safety, and have set procedures to assure the concomitant results. However, when compared at the operational level, they can be best described as very different. Good Laboratory Practice programs deal basically with two governmental agencies and their divisions- the Environmental Protection Agency and Food and Drug Administration. These are administered from the federal level involving no state resources. These programs are objective driven with the procedures being defined in study plans, protocols, and standard operating procedures. The environmental monitoring testing programs deal with a profusion of federal legislation including CERCLA (also known as CLP), RCRA, CWA, CAA, SDWA, NPDES and others. These acts require analysis by specific procedures mandated by the statutes. States operate many of these programs and have been given the authority by the federal government. Many of the states require separate certifications to conduct these analyses. Environmental monitoring testing laboratories often must acquire multiple state certifications to participate in multiple state programs. This is not cost effective and often leads to conflicting requirements. Much of the direction for having a national certification program comes from problems associated with these state-operated programs. PMID:8890354

  19. Good laboratory practices for biochemical genetic testing and newborn screening for inherited metabolic disorders.

    PubMed

    2012-04-01

    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. 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…

  1. Identity, emotion and the internal goods of practice: a study of learning disability professionals.

    PubMed

    Fisher, Pamela; Byrne, Victoria

    2012-01-01

    Contemporary transitions in the delivery of health and social care are a global phenomenon. They prompt a particular need to reconsider how quality in relation to professional practice should be understood and whether greater importance should be attached to values such as goodwill, altruism and commitment. Based on a qualitative study of a small voluntary sector organisation in the North of England, this paper addresses how changes in policy articulate with the identities of professionals who work in learning disability services. Drawing on MacIntyre's After Virtue, which is discussed in relation to some recent sociological debates on emotion, it is suggested that professionals have an emotionally based commitment to their work as well as to the people they work with. Professional commitment is embedded in a coherent sense of self that problematises traditional binaries between the private and the public, and the cognitive and affective. The participants in this study appeared to pursue what MacIntyre terms the 'internal goods' of practice; they valued being able to work innovatively and responsively with service users. It is suggested that this requires a particular type of relationship with oneself, with others, and with practice, which engenders a criticality towards dominant professional discourses.

  2. [Principles and methods of good practice for the translation process for instruments of nursing research and nursing practice].

    PubMed

    Martin, Jacqueline S; Vincenzi, Christine; Spirig, Rebecca

    2007-06-01

    Cross-cultural, valid and reliable instruments are increasingly used in nursing, yet their attainment is labour-intensive. The translation of valid instruments into another language and cultural context is the most common method used for generating cross-cultural instruments. This approach is challenging since the development of culturally equivalent translated instruments demands familiarity with basic requirements of linguistic adaptation, cultural concepts and psychometric changes inherent in the translation process. However, the quality of data derived from translated instruments relies on the accuracy of the translation process applied. The aim of this article is to illustrate the different methods for translation, as well as to present an example and principles of good practice regarding this subject.

  3. 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.

  4. 2 CFR 176.160 - Award term-Required Use of American Iron, Steel, and Manufactured Goods (covered under...

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... appropriate, by at least the differential established in 2 CFR 176.110(a). (3) Unless the Federal Government..., Romania, Singapore, Slovak Republic, Slovenia, Spain, Sweden, Switzerland, and United Kingdom; (2) A Free..., Spain, Sweden, and United Kingdom. Designated country iron, steel, and/or manufactured goods—(1)...

  5. Community learning disability teams: developments, composition and good practice: a review of the literature.

    PubMed

    Slevin, Eamonn; Truesdale-Kennedy, Maria; McConkey, Roy; Barr, Owen; Taggart, Laurence

    2008-03-01

    This article presents the findings from a literature review related to community learning disability teams (CLDTs). Much of the existing literature on CLDTs is inspirational, theoretical or opinion based rather than evidence based. It was considered that current knowledge is insufficient to allow a systematic review; therefore a structured review of factors that impact on CLDTs was undertaken following some of the principles of a systematic review. The review covers historical and philosophical influences on the development of CLDTs; the structure and common composition of CLDTs; the main challenges facing CLDTs; and the barriers that impact on their effective working. Based on the available evidence a number of good practice suggestions are forwarded that have the potential to enhance the work undertaken by CLDTs, but it is acknowledged that there is a need for more research into the effectiveness of these teams. PMID:18337302

  6. Good modelling practice in applying computational fluid dynamics for WWTP modelling.

    PubMed

    Wicklein, Edward; Batstone, Damien J; Ducoste, Joel; Laurent, Julien; Griborio, Alonso; Wicks, Jim; Saunders, Stephen; Samstag, Randal; Potier, Olivier; Nopens, Ingmar

    2016-01-01

    Computational fluid dynamics (CFD) modelling in the wastewater treatment (WWT) field is continuing to grow and be used to solve increasingly complex problems. However, the future of CFD models and their value to the wastewater field are a function of their proper application and knowledge of their limits. As has been established for other types of wastewater modelling (i.e. biokinetic models), it is timely to define a good modelling practice (GMP) for wastewater CFD applications. An International Water Association (IWA) working group has been formed to investigate a variety of issues and challenges related to CFD modelling in water and WWT. This paper summarizes the recommendations for GMP of the IWA working group on CFD. The paper provides an overview of GMP and, though it is written for the wastewater application, is based on general CFD procedures. A forthcoming companion paper to provide specific details on modelling of individual wastewater components forms the next step of the working group.

  7. DOE handbook: Guide to good practices for the selection, training, and qualification of shift supervisors

    SciTech Connect

    1999-04-01

    This Department of Energy (DOE) handbook is approved for use by all DOE Components and their contractors. The Handbook incorporates editorial changes to DOE-STD-1061-93, ``Guide to Good Practices for the Selection, Training, and Qualification of shift Supervisors,`` and supersedes DOE-STD-1061-93. Technical content of this Handbook has not changed from the original technical standard. Changes are primarily editorial improvements, redesignation of the standard to a Handbook, and format changes to conform with current Technical Standards Program procedures. This guide, used in conjunction with a facility-specific job analysis, provides a framework for the selection, training, qualification, and professional development of reactor facility and non-reactor nuclear facility shift supervisors. Training and qualification programs based on this guide should provide assurance that shift supervisors perform their jobs safely and competently.

  8. Medication Errors: New EU Good Practice Guide on Risk Minimisation and Error Prevention.

    PubMed

    Goedecke, Thomas; Ord, Kathryn; Newbould, Victoria; Brosch, Sabine; Arlett, Peter

    2016-06-01

    A medication error is an unintended failure in the drug treatment process that leads to, or has the potential to lead to, harm to the patient. Reducing the risk of medication errors is a shared responsibility between patients, healthcare professionals, regulators and the pharmaceutical industry at all levels of healthcare delivery. In 2015, the EU regulatory network released a two-part good practice guide on medication errors to support both the pharmaceutical industry and regulators in the implementation of the changes introduced with the EU pharmacovigilance legislation. These changes included a modification of the 'adverse reaction' definition to include events associated with medication errors, and the requirement for national competent authorities responsible for pharmacovigilance in EU Member States to collaborate and exchange information on medication errors resulting in harm with national patient safety organisations. To facilitate reporting and learning from medication errors, a clear distinction has been made in the guidance between medication errors resulting in adverse reactions, medication errors without harm, intercepted medication errors and potential errors. This distinction is supported by an enhanced MedDRA(®) terminology that allows for coding all stages of the medication use process where the error occurred in addition to any clinical consequences. To better understand the causes and contributing factors, individual case safety reports involving an error should be followed-up with the primary reporter to gather information relevant for the conduct of root cause analysis where this may be appropriate. Such reports should also be summarised in periodic safety update reports and addressed in risk management plans. Any risk minimisation and prevention strategy for medication errors should consider all stages of a medicinal product's life-cycle, particularly the main sources and types of medication errors during product development. This article

  9. Development and implementation of the Good Neighbor Agreement (GNA) practice in the USA sustainable mining development.

    NASA Astrophysics Data System (ADS)

    Masaitis, Alexandra

    2014-05-01

    New economic, environmental and social challenges for the mining industry in the USA show the need to implement "responsible" mining practices that include improved community involvement. Conflicts which occur in the US territory and with US mining companies around the world are now common between the mining proponents, NGO's and communities. These conflicts can sometimes be alleviated by early development of modes of communication, and a formal discussion format that allows airing of concerns and potential resolution of problems. One of the methods that can formalize this process is to establish a Good Neighbor Agreement (GNA), which deals specifically with challenges in relationships between mining operations and the local communities. It is a new practice related to mining operations that are oriented toward social needs and concerns of local communities that arise during the normal life of a mine, which can achieve sustainable mining practices. The GNA project being currently developed at the University of Nevada, USA in cooperation with the Newmont Mining Corporation has a goal of creating an open company/community dialog that will help identify and address sociological and environmental concerns associated with mining. Discussion: The Good Neighbor Agreement currently evolving will address the following: 1. Identify spheres of possible cooperation between mining companies, government organizations, and NGO's. 2. Provide an economically viable mechanism for developing a partnership between mining operations and the local communities that will increase mining industry's accountability and provide higher levels of confidence for the community that a mine is operated in a safe and sustainable manner. Implementation of the GNA can help identify and evaluate conflict criteria in mining/community relationships; determine the status of concerns; determine the role and responsibilities of stakeholders; analyze problem resolution feasibility; maintain the community

  10. Practical aspects of modern interferometry for optical manufacturing quality control: Part 1

    NASA Astrophysics Data System (ADS)

    Smythe, Robert

    2012-03-01

    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 reviews some of the key issues to minimize error sources in that data and provide a valid measurement.

  11. The procurement of cells for the derivation of human embryonic stem cell lines for therapeutic use: recommendations for good practice.

    PubMed

    Murdoch, Alison; Braude, Peter; Courtney, Aidan; Brison, Daniel; Hunt, Charles; Lawford-Davies, James; Moore, Harry; Stacey, Glyn; Sethe, Sebastian

    2012-03-01

    The donation of human embryos for the derivation of embryonic stem cell lines that may be used in the development of therapeutic products raises more complex ethical, practical and regulatory problems than the donation of embryos for non-clinical research. This review considers these issues and offers recommendations for good practice. PMID:21671059

  12. The procurement of cells for the derivation of human embryonic stem cell lines for therapeutic use: recommendations for good practice.

    PubMed

    Murdoch, Alison; Braude, Peter; Courtney, Aidan; Brison, Daniel; Hunt, Charles; Lawford-Davies, James; Moore, Harry; Stacey, Glyn; Sethe, Sebastian

    2012-03-01

    The donation of human embryos for the derivation of embryonic stem cell lines that may be used in the development of therapeutic products raises more complex ethical, practical and regulatory problems than the donation of embryos for non-clinical research. This review considers these issues and offers recommendations for good practice.

  13. Medication Errors: New EU Good Practice Guide on Risk Minimisation and Error Prevention.

    PubMed

    Goedecke, Thomas; Ord, Kathryn; Newbould, Victoria; Brosch, Sabine; Arlett, Peter

    2016-06-01

    A medication error is an unintended failure in the drug treatment process that leads to, or has the potential to lead to, harm to the patient. Reducing the risk of medication errors is a shared responsibility between patients, healthcare professionals, regulators and the pharmaceutical industry at all levels of healthcare delivery. In 2015, the EU regulatory network released a two-part good practice guide on medication errors to support both the pharmaceutical industry and regulators in the implementation of the changes introduced with the EU pharmacovigilance legislation. These changes included a modification of the 'adverse reaction' definition to include events associated with medication errors, and the requirement for national competent authorities responsible for pharmacovigilance in EU Member States to collaborate and exchange information on medication errors resulting in harm with national patient safety organisations. To facilitate reporting and learning from medication errors, a clear distinction has been made in the guidance between medication errors resulting in adverse reactions, medication errors without harm, intercepted medication errors and potential errors. This distinction is supported by an enhanced MedDRA(®) terminology that allows for coding all stages of the medication use process where the error occurred in addition to any clinical consequences. To better understand the causes and contributing factors, individual case safety reports involving an error should be followed-up with the primary reporter to gather information relevant for the conduct of root cause analysis where this may be appropriate. Such reports should also be summarised in periodic safety update reports and addressed in risk management plans. Any risk minimisation and prevention strategy for medication errors should consider all stages of a medicinal product's life-cycle, particularly the main sources and types of medication errors during product development. This article

  14. The Good Behavior Game: a best practice candidate as a universal behavioral vaccine.

    PubMed

    Embry, Dennis D

    2002-12-01

    A "behavioral vaccine" provides an inoculation against morbidity or mortality, impacting physical, mental, or behavior disorders. An historical example of a behavioral vaccine is antiseptic hand washing to reduce childbed fever. In current society, issues with high levels of morbidity, such as substance abuse, delinquency, youth violence, and other behavioral disorders (multiproblems), cry out for a low-cost, widespread strategy as simple as antiseptic hand washing. Congruent research findings from longitudinal studies, twin studies, and other investigations suggest that a possibility might exist for a behavioral vaccine for multiproblem behavior. A simple behavioral strategy called the Good Behavior Game (GBG), which reinforces inhibition in a group context of elementary school, has substantial previous research to consider its use as a behavioral vaccine. The GBG is not a curriculum but rather a simple behavioral procedure from applied behavior analysis. Approximately 20 independent replications of the GBG across different grade levels, different types of students, different settings, and some with long-term follow-up show strong, consistent impact on impulsive, disruptive behaviors of children and teens as well as reductions in substance use or serious antisocial behaviors. The GBG, named as a "best practice" for the prevention of substance abuse or violent behavior by a number of federal agencies, is unique because it is the only practice implemented by individual teachers that is documented to have long-term effects. Presently, the GBG is only used in a small number of settings. However, near universal use of the GBG, in major political jurisdictions during the elementary years, could substantially reduce the incidence of substance use, antisocial behavior, and other adverse developmental or social consequences at a very modest cost, with very positive cost-effectiveness ratios.

  15. The OECD policy for the implementation of the principles of good laboratory practice.

    PubMed

    Turnheim, D

    1994-01-01

    OECD has been involved in the harmonisation of policies and instruments for chemicals control since the late 1970's. The OECD principles of good laboratory practice (GLP) were developed and subsequently adopted by the Council in 1981. These principles have the primary objective of ensuring the generation of high quality test data. They set out managerial concepts covering the organisation of test laboratories as well as the conditions under which laboratory studies are planned, performed, monitored, recorded and reported. A system of compliance monitoring procedures has been established to ensure that laboratory studies are carried out in member countries according to the principles of GLP. The harmonization and mutual recognition of compliance monitoring methods among member countries have been a crucial step in ensuring the international acceptability of data. This undertaking involved the development of consistent criteria for determining whether a laboratory conducts studies in accordance with the principles of GLP. Training courses are held for GLP inspectors, an activity which lies at the basis of harmonising monitoring procedures. Consensus workshops result in consensus documents on the harmonised application and interpretation of the GLP principles in specific areas or on specific points. This system makes it possible for countries to speak the same language when exchanging information about specific laboratories, and to have confidence in the quality and rigour of safety tests undertaken in a laboratory.

  16. Guide to good practices for the selection, training, and qualification of shift technical advisors

    SciTech Connect

    1993-02-01

    The DOE Guide to Good Practices For the Selection, Training, and Qualification of Shift Technical Advisors can be used by any DOE nuclear facility that has implemented the shift technical advisor (STA) position. DOE Order 5480.20A, Personnel Selection, Qualification and Training Requirements for DOE Nuclear Facilities, states that only Category A reactors must have a shift technical advisor. However, many DOE nuclear facilities have implemented the shift technical advisor position to provide independent on-shift technical advice and counsel to the shift operating personnel to help determine cause and mitigation of facility accidents. Those DOE nuclear facilities that have implemented or are going to implement the shift technical advisor position will find this guide useful. This guide addresses areas that may be covered by other training programs. In these cases, it is unnecessary (and undesirable) to duplicate these areas in the STA training program as long as the specific skills and knowledge essential for STAs are addressed. The guide is based on the premise that the trainee has not completed any facility-specific training other than general employee training.

  17. DOE handbook: Guide to good practices for training and qualification of maintenance personnel

    SciTech Connect

    1996-03-01

    The purpose of this Handbook is to provide contractor training organizations with information that can be used to verify the adequacy of and/or modify existing maintenance training programs, or to develop new training programs. This guide, used in conjunction with facility-specific job analyses, provides a framework for training and qualification programs for maintenance personnel at DOE reactor and nonreactor nuclear facilities. Recommendations for qualification are made in four areas: education, experience, physical attributes, and training. The functional positions of maintenance mechanic, electrician, and instrumentation and control technician are covered by this guide. Sufficient common knowledge and skills were found to include the three disciplines in one guide to good practices. Contents include: qualifications; on-the-job training; trainee evaluation; continuing training; training effectiveness evaluation; and program records. Appendices are included which relate to: administrative training; industrial safety training; fundamentals training; tools and equipment training; facility systems and component knowledge training; facility systems and component skills training; and specialized skills training.

  18. Searching for good practice recommendations on body donation across diverse cultures.

    PubMed

    Jones, David Gareth

    2016-01-01

    Good practice recommendations for the donation of human bodies and tissues for anatomical examination have been produced by the International Federation of Associations of Anatomists (IFAA). Against the background of these recommendations, the ethical values underlying them were outlined. These were the centrality of informed consent, their non-commercial nature, and the respect due to all associated with donations including family members. The latter was exemplified in part by the institution of thanksgiving services and commemorations. A number of issues in the recommendations were discussed, including the movement of bodies across national borders, donor anonymity, taking images of bodies and body parts, and the length of time for which bodies can be kept. Outstanding questions in connection with body donation included the availability of bodies for research as well as teaching, allowing TV cameras into the dissecting room, and the display of archival material in anatomy museums. Future prospects included whether IFAA could be formulating a position on the public exhibition of plastinated human material, and in what ways IFAA could assist countries currently dependent upon the use of unclaimed bodies.

  19. [Ecological agriculture: future of Good Agriculture Practice of Chinese materia medica].

    PubMed

    Guo, Lan-ping; Zhou, Liang-yun; Mo, Ge; Wang, Sheng; Huang, Lu-qi

    2015-09-01

    Based on the ecological and economic problems in Good Agriculture Practice (GAP) of Chinese material medica, we introduced the origin, concept, features and operative technology of eco-agriculture worldwide, emphasizing its modes on different biological levels of landscape, ecosystem, community, population, individual and gene in China. And on this basis, we analyzed the background and current situation of eco-agriculture of Chinese materia medica, and proposed its development ideas and key tasks, including: (1) Analysis and planning of the production pattern of Chinese material medica national wide. (2) Typical features extraction of regional agriculture of Chinese materia medica. (3) Investigation of the interaction and its mechanism between typical Chinese materia medica in each region and the micro-ecology of rhizosphere soil. (4) Study on technology of eco-agriculture of Chinese materia medica. (5) Extraction and solidification of eco-agriculture modes of Chinese materia medica. (6) Study on the theory of eco-agriculture of Chinese materia medica. Also we pointed out that GAP and eco-agriculture of Chinese material medica are both different and relative, but they are not contradictory with their own features. It is an irresistible trend to promote eco-agriculture in the GAP of Chinese material medica and coordinate ecological and economic development.

  20. Making abortions safe: a matter of good public health policy and practice.

    PubMed Central

    Berer, M.

    2000-01-01

    Globally, abortion mortality accounts for at least 13% of all maternal mortality. Unsafe abortion procedures, untrained abortion providers, restrictive abortion laws and high mortality and morbidity from abortion tend to occur together. Preventing mortality and morbidity from abortion in countries where these remain high is a matter of good public health policy and medical practice, and constitutes an important part of safe motherhood initiatives. This article examines the changes in policy and health service provision required to make abortions safe. It is based on a wide-ranging review of published and unpublished sources. In order to be effective, public health measures must take into account the reasons why women have abortions, the kind of abortion services required and at what stages of pregnancy, the types of abortion service providers needed, and training, cost and counselling issues. The transition from unsafe to safe abortions demands the following: changes at national policy level; abortion training for service providers and the provision of services at the appropriate primary level health service delivery points; and ensuring that women access these services instead of those of untrained providers. Public awareness that abortion services are available is a crucial element of this transition, particularly among adolescent and single women, who tend to have less access to reproductive health services generally. PMID:10859852

  1. Guide to good practices for the design, development, and implementation of examinations

    SciTech Connect

    1997-06-01

    The purpose of this Guide to Good Practices is to provide direction to training personnel in the broad areas of design, development, and implementation of examinations. Nuclear facilities spend a significant amount of training resources testing trainees. Tests are used for employee selection, qualification, requalification, certification and recertification, and promotion. Ineffective testing procedures, or inappropriate interpretation of test results, can have significant effects on both human performance and facility operations. Test development requires unique skills, and as with any skill, training and experience are needed to develop the skills. Test development, test use, test result interpretation, and test refinement, like all other aspects of the systematic approach to training, should be part of an ongoing, systematic process. For some users this document will provide a review of ideas and principles with which they are already familiar; for others it will present new concepts. While not intended to provide in-depth coverage of test theory design and development, it should provide developers, instructors, and evaluators with a foundation on which to develop sound examinations.

  2. 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

  3. [Good agricultural practice (GAP) of Chinese materia medica (CMM) for ten years: achievements, problems and proposals].

    PubMed

    Guo, Lan-Ping; Zhang, Yan; Zhu, Shou-Dong; Wang, Gui-Hua; Wang, Xiu; Zhang, Xiao-Bo; Chen, Mei-Lan; He, Ya-Li; Han, Bang-Xing; Chen, Nai-Fu; Huang, Lu-Qi

    2014-04-01

    This paper aims to summarize the achievements during the implementation process of good agricultural practice (GAP) in Chinese Materia Medica (CMM), and on basis of analyzing the existing problems of GAP, to propose further implementation of GAP in TCM growing. Since the launch of GAP in CMM growing ten years ago, it has acquired great achievements, including: (1) The promulgation of a series of measures for the administration of the GAP approval in the CMM growing; (2) The expanded planting area of CMM; (3) The increased awareness of standardized CMM growing among farmers and enterprises; (4) The establishment of GAP implementation bases for CMM growing; (5) The improvement of theory and methodology for CMM growing; (6) The development of a large group of experts and scholars in GAP approval for CMM production. The problems existing in the production include: (1) A deep understanding of GAP and its certification is still needed; (2) The distribution of the certification base is not reasonable; (3) The geo-economics effect and the backward farming practices are thought to be the bottlenecks in the standardization of CMM growing and the scale production of CMM; (4) Low comparative effectiveness limits the development of the GAP; (5) The base of breeding improved variety is blank; (6) The immature of the cultivation technique lead to the risk of production process; (7) The degradation of soil microbial and the continuous cropping obstacle restrict the sustainable development of the GAP base. To further promote the health and orderly GAP in the CMM growing, the authors propose: (1) To change the mode of production; (2) To establish a sound standard system so as to ensure quality products for fair prices; (3) To fully consider the geo-economic culture and vigorously promote the definite cultivating of traditional Chinese medicinal materials; (4) To strengthen the transformation and generalization of basic researches and achievements, in order to provide technical

  4. [Good agricultural practice (GAP) of Chinese materia medica (CMM) for ten years: achievements, problems and proposals].

    PubMed

    Guo, Lan-Ping; Zhang, Yan; Zhu, Shou-Dong; Wang, Gui-Hua; Wang, Xiu; Zhang, Xiao-Bo; Chen, Mei-Lan; He, Ya-Li; Han, Bang-Xing; Chen, Nai-Fu; Huang, Lu-Qi

    2014-04-01

    This paper aims to summarize the achievements during the implementation process of good agricultural practice (GAP) in Chinese Materia Medica (CMM), and on basis of analyzing the existing problems of GAP, to propose further implementation of GAP in TCM growing. Since the launch of GAP in CMM growing ten years ago, it has acquired great achievements, including: (1) The promulgation of a series of measures for the administration of the GAP approval in the CMM growing; (2) The expanded planting area of CMM; (3) The increased awareness of standardized CMM growing among farmers and enterprises; (4) The establishment of GAP implementation bases for CMM growing; (5) The improvement of theory and methodology for CMM growing; (6) The development of a large group of experts and scholars in GAP approval for CMM production. The problems existing in the production include: (1) A deep understanding of GAP and its certification is still needed; (2) The distribution of the certification base is not reasonable; (3) The geo-economics effect and the backward farming practices are thought to be the bottlenecks in the standardization of CMM growing and the scale production of CMM; (4) Low comparative effectiveness limits the development of the GAP; (5) The base of breeding improved variety is blank; (6) The immature of the cultivation technique lead to the risk of production process; (7) The degradation of soil microbial and the continuous cropping obstacle restrict the sustainable development of the GAP base. To further promote the health and orderly GAP in the CMM growing, the authors propose: (1) To change the mode of production; (2) To establish a sound standard system so as to ensure quality products for fair prices; (3) To fully consider the geo-economic culture and vigorously promote the definite cultivating of traditional Chinese medicinal materials; (4) To strengthen the transformation and generalization of basic researches and achievements, in order to provide technical

  5. Information Quality in Regulatory Decision Making: Peer Review versus Good Laboratory Practice

    PubMed Central

    Borgert, Christopher J.; Mihaich, Ellen M.

    2012-01-01

    Background: There is an ongoing discussion on the provenance of toxicity testing data regarding how best to ensure its validity and credibility. A central argument is whether journal peer-review procedures are superior to Good Laboratory Practice (GLP) standards employed for compliance with regulatory mandates. Objective: We sought to evaluate the rationale for regulatory decision making based on peer-review procedures versus GLP standards. Method: We examined pertinent published literature regarding how scientific data quality and validity are evaluated for peer review, GLP compliance, and development of regulations. Discussion: Some contend that peer review is a coherent, consistent evaluative procedure providing quality control for experimental data generation, analysis, and reporting sufficient to reliably establish relative merit, whereas GLP is seen as merely a tracking process designed to thwart investigator corruption. This view is not supported by published analyses pointing to subjectivity and variability in peer-review processes. Although GLP is not designed to establish relative merit, it is an internationally accepted quality assurance, quality control method for documenting experimental conduct and data. Conclusions: Neither process is completely sufficient for establishing relative scientific soundness. However, changes occurring both in peer-review processes and in regulatory guidance resulting in clearer, more transparent communication of scientific information point to an emerging convergence in ensuring information quality. The solution to determining relative merit lies in developing a well-documented, generally accepted weight-of-evidence scheme to evaluate both peer-reviewed and GLP information used in regulatory decision making where both merit and specific relevance inform the process. PMID:22343028

  6. Clinical trials and the new good clinical practice guideline in Japan. An economic perspective.

    PubMed

    Ono, S; Kodama, Y

    2000-08-01

    Japanese clinical trials have been drastically changing in response to the implementation of the International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) guideline in 1997. The most important aim of the new guideline is to standardise the quality of clinical trials in the US, European Union and Japan, but it inevitably imposes substantial costs on investigators, sponsors and even patients in Japan. The study environment in Japan differs from that in the US in several ways: (i) historical lack of a formal requirement for informed consent; (ii) patients' attitudes to clinical trials in terms of expectation of positive outcomes; (iii) the implications of universal health insurance for trial participation; (iv) the historical absence of on-site monitoring by the sponsor, with the attendant effects on study quality; and (v) the lack of adequate financial and personnel support for the conduct of trials. Implementation of the new GCP guideline will improve the ethical and scientific quality of trials conducted in Japan. It may also lead to an improved relationship between medical professionals and patients if the requirement for explicit informed consent in clinical trials leads to the provision of a similar level of patient information in routine care and changes the traditional paternalistic attitude of physicians to patients. The initial response of the Japanese 'market' for clinical trials to the implementation of the ICH-GCP guideline has been clinical trial price increases and a decrease in the number of study contracts. These changes can be explained by applying a simple demand-supply scheme. Whether clinical trials undertaken in Japan become more or less attractive to the industry in the long term will depend on other factors such as international regulations on the acceptability of foreign clinical trials and the reform of domestic healthcare policies. PMID:11067647

  7. 21 CFR 111.210 - What must the master manufacturing record include?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 2 2011-04-01 2011-04-01 false What must the master manufacturing record include... SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING...: Requirements for the Master Manufacturing Record § 111.210 What must the master manufacturing record...

  8. 21 CFR 111.210 - What must the master manufacturing record include?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 2 2010-04-01 2010-04-01 false What must the master manufacturing record include... SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING...: Requirements for the Master Manufacturing Record § 111.210 What must the master manufacturing record...

  9. 21 CFR 111.210 - What must the master manufacturing record include?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 2 2014-04-01 2014-04-01 false What must the master manufacturing record include... SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING...: Requirements for the Master Manufacturing Record § 111.210 What must the master manufacturing record...

  10. 21 CFR 111.210 - What must the master manufacturing record include?

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 2 2013-04-01 2013-04-01 false What must the master manufacturing record include... SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING...: Requirements for the Master Manufacturing Record § 111.210 What must the master manufacturing record...

  11. 21 CFR 111.210 - What must the master manufacturing record include?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 2 2012-04-01 2012-04-01 false What must the master manufacturing record include... SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING...: Requirements for the Master Manufacturing Record § 111.210 What must the master manufacturing record...

  12. [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.

  13. A Review of Supply Chain Collaboration Practices for Small and Medium-sized Manufacturers

    NASA Astrophysics Data System (ADS)

    Wee, SY; Thoo, AC; Z, Sulaiman; FM, Muharam

    2016-05-01

    For the decades, organizations have endeavored to look for external sources for opportunities to achieve efficient and responsive supply chain with their partners especially for small and medium manufacturers (SMM). In this scenario, supply chain collaboration (SCC) is an interaction between supply chain members with the purpose of utilizes the knowledge and resources of customers and suppliers, and integrates the flows of products and information in order to achieve a common goal and obtain mutual benefit. The essential SCC dimensions for SMMs comprised of information sharing, joint knowledge creation, joint decision making, goal congruence and incentive sharing. The successful implementation of SCC can give SMMs an edge over their competitors. This paper aims to introduce a review of SCC practices for SMM. Overall, the findings provide managerial insights for the SMM in SCC implementation owing to resource scarcity and the need to draw SCC in order to ensure a sustainable competitive advantage.

  14. 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.

  15. 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.

  16. PATONGO: Patterns and Tools for Non-Profit Organizations—a pattern-based approach for helping volunteers to identify and share good practice

    NASA Astrophysics Data System (ADS)

    Schümmer, Till; Haake, Jörg M.

    2010-04-01

    Identification and sharing of good practice is an essential ingredient for collaborative voluntary action in non-profit organizations. While current approaches for sharing good practice focus on adopting and describing good practice individually, they fail to address collaborative detection, description, and appropriation of good practice in organizations. We propose a pattern-based approach, which facilitates collaborative creation, improvement, and sharing of good practice via Web 2.0 concepts. First experiences with the approach are presented including a field experiment where the approach was implemented in the Evangelic Church of Germany.

  17. HIV & AIDS and Educator Development, Conduct and Support. Good Policy and Practice in HIV & AIDS and Education. Booklet 3

    ERIC Educational Resources Information Center

    Attawell, Kathy; Elder, Katharine

    2006-01-01

    Although there is a need for enhanced evidence-based information on successful HIV and AIDS education interventions, much has already been learnt about good practices and policies in the education sector's response to the pandemic. This booklet, to be used in tandem with others in the series, aims to further expand our knowledge by highlighting…

  18. Good Practice in Promoting Gender Equality in Higher Education in Central and Eastern Europe. Studies on Higher Education.

    ERIC Educational Resources Information Center

    Grunberg, Laura

    This volume publishes the results of the United Nations Educational, Scientific, and Cultural Organization (UNESCO) European Centre for Higher Education (CEPES) project, Good Practice in Promoting Gender Inequality in Higher Education in Central and Eastern Europe and the former Soviet Countries. These case studies offer hope for a future in which…

  19. Good practice in health care for migrants: views and experiences of care professionals in 16 European countries

    PubMed Central

    2011-01-01

    Background Health services across Europe provide health care for migrant patients every day. However, little systematic research has explored the views and experiences of health care professionals in different European countries. The aim of this study was to assess the difficulties professionals experience in their service when providing such care and what they consider constitutes good practice to overcome these problems or limit their negative impact on the quality of care. Methods Structured interviews with open questions and case vignettes were conducted with health care professionals working in areas with high proportion of migrant populations in 16 countries. In each country, professionals in nine primary care practices, three accident and emergency hospital departments, and three community mental health services (total sample = 240) were interviewed about their views and experiences in providing care for migrant patients, i.e. from first generation immigrant populations. Answers were analysed using thematic content analysis. Results Eight types of problems and seven components of good practice were identified representing all statements in the interviews. The eight problems were: language barriers, difficulties in arranging care for migrants without health care coverage, social deprivation and traumatic experiences, lack of familiarity with the health care system, cultural differences, different understandings of illness and treatment, negative attitudes among staff and patients, and lack of access to medical history. The components of good practice to overcome these problems or limit their impact were: organisational flexibility with sufficient time and resources, good interpreting services, working with families and social services, cultural awareness of staff, educational programmes and information material for migrants, positive and stable relationships with staff, and clear guidelines on the care entitlements of different migrant groups. Problems and

  20. Teaching Good and Teaching Well: Integrating Values with Theory and Practice.

    ERIC Educational Resources Information Center

    Myers, Eleanor W.

    1997-01-01

    Describes a Temple University (Pennsylvania) law school course that combines the teaching of theory and practice, keeps upper-level students engaged in active learning, and provides a concrete and realistic context in which students can experience the moral dimension of practice. The course combines trusts and estates, professional responsibility,…

  1. The Good Housewife Exercise: Linking Citation to Practices, Evidence, and Claims.

    ERIC Educational Resources Information Center

    Hansberger, Richard

    1999-01-01

    Presents a one-class-period writing exercise (including handout) which uses a short excerpt from a 1948 book called "Making Housekeeping Easy" to teach the linking of claims to evidence as well as academic citation practices. (SR)

  2. Principals' Tacit Knowledge of Good Instruction: Implications for Policy and Practice

    ERIC Educational Resources Information Center

    Stevenson, Isobel Page

    2013-01-01

    The purpose of this study was to explore what school administrators are looking for when they visit classrooms, and to discern the source of their concept of good instruction, particularly the role of experience. The research design was qualitative, involving interviewing 14 principals. The results of principals' responses show that they are…

  3. Raising the Achievement of Portuguese Pupils in British Schools: A Case Study of Good Practice

    ERIC Educational Resources Information Center

    Demie, Feyisa; Lewis, Kirstin

    2010-01-01

    The aim of the research was to study the experiences of Portuguese heritage pupils in British schools. The main findings from empirical data suggest Portuguese children are underachieving at the end of primary education but the case study confirms that in good schools Portuguese pupils do well and have made huge improvements over the periods. The…

  4. The advanced practice professionals' perspective: keys to a good working relationship between advanced practice professions and physicians.

    PubMed

    Polansky, Maura

    2013-01-01

    A strong working relationship between advanced practice professionals (APPs) and supervising oncologists is essential for reducing medical errors, retaining employees, and improving work environments. Although there is rather limited data on the unique relationship of the APP and physician, fundamental communication skills-including open communication, mutual respect, establishing expectations, and working with mutual purpose-should be the foundation of these relationships. This paper addresses various aspects of relationship building between APPs and physicians with suggestions for establishing successful working relationships.

  5. Quality of operation notes in orthopaedic hip arthroplasty surgery: are we complying with British Orthopaedic Association's guide to good practice?

    PubMed

    Menakaya, C U; Ingoe, H; Malhotra, R; Shah, M; Boddice, T; Mohsen, A

    2013-12-01

    This retrospective audit evaluates the compliance of our operation notes with the British Orthopaedic Society Primary Hip Arthroplasty 'A guide to good practice' using a 24-data point question (BOA 2006). Ninety-nine notes reviewed, of which 94% had patient identifiers, the surgical team was documented in 92.5%, post-operative instruction in 97%, and prosthesis stability in 97% of cases. Despite high standards, we did not achieve the 100% gold standard. We suggest that increased awareness of the 24-point BOA guideline via education and proformas would help to ensure better practice

  6. Good CoP: What Makes a Community of Practice Successful?

    ERIC Educational Resources Information Center

    Baker, Anthony; Beames, Stephanie

    2016-01-01

    We have established a community of practice focussed on student learning in first-year science. It is recognised that transition, whether from school to university or other possible transitions, is an issue that is a concern for the entire sector, and this is acknowledged both at Faculty and University level. One of the factors to which we…

  7. The Good, the Bad, and the Ugly of Evidence-Based Practice

    ERIC Educational Resources Information Center

    Bouffard, Marcel; Reid, Greg

    2012-01-01

    The evidence-based practice (EBP) movement has been extremely influential over the last 20 years. Fields like medicine, physiotherapy, occupational therapy, nursing, psychology, and education have adopted the idea that policy makers and practitioners should use interventions that have demonstrated efficiency and effectiveness. This apparently…

  8. A Guide to Providing Social Support for Apprentices. Good Practice Guide

    ERIC Educational Resources Information Center

    National Centre for Vocational Education Research (NCVER), 2016

    2016-01-01

    The main purpose of this guide is to provide some ideas for employers of apprentices to provide an environment in which strong informal bases of support can succeed. Formal mentoring is an important aspect of apprenticeships; however, it is also informal mentoring--practices that are difficult to formally nurture--that plays a significant and…

  9. Good Teaching? An Examination of Culturally Relevant Pedagogy as an Equity Practice

    ERIC Educational Resources Information Center

    Schmeichel, Mardi

    2012-01-01

    The adoption of educational policy measures to close the achievement gap, as well as the significant amount of scholarship dedicated to the subject, are just some of the indicators that reflect the tremendous concern in education about the academic performance of students of colour. Within research aimed at promoting equitable practices in…

  10. "Really Good Ideas?" Developing Evidence-Informed Policy and Practice in Education Leadership and Management.

    ERIC Educational Resources Information Center

    Levacic, Rosalind; Glatter, Ron

    2001-01-01

    Examines the potential for evidence-informed policy and practice (EIPP) in relation to educational leadership. Considers definitions, models, and factors promoting and inhibiting development of EIPP as a professional norm. Discusses two collaborative efforts to organize the validation stage of the EIPP cycle. (Contains 60 references.) (MLH)

  11. Theory in Practice: Why "Good Medicine" and "Scientific Medicine" Are Not Necessarily the Same Thing

    ERIC Educational Resources Information Center

    De Camargo, Kenneth, Jr.; Coeli, Claudia Medina

    2006-01-01

    The term "scientific medicine", ubiquitous in medical literature although poorly defined, can be traced to a number of assumptions, three of which are examined in this paper: that medicine is a form of knowledge-driven practice, where the established body of proven medical knowledge determines what doctors do; if what doctors do is either…

  12. Identification of good practices for teachers and students training activity in the ENVRIPLUS project

    NASA Astrophysics Data System (ADS)

    D'Addezio, Giuliana; Marsili, Antonella; Beranzoli, Laura

    2016-04-01

    We elaborated basic guiding principles that will be used to improve the content of the ENVRIPLUS e-Training Platform for multimedia education of Secondary School level teachers and students. The purpose is to favour teacher training and consequently students training on selected scientific themes faced within the ENVRIPLUS Research Infrastructures. "Best practices" could positively impacts on students by providing motivation on promoting scientific research and to increase the awareness of the Earth System complexity and Environmental challenges for its preservation and sustainability. Best practice teaching strategies represent an inherent part of a curriculum that exemplifies the connection and relevance identified in education research. The actions are designed to develop thinking and problem-solving skill through integration and active learning. Relationships are built though opportunities for communication and teamwork. Best practices motivate, engage and prompt student to learn and achieve. A starting list of principles is discussed in respect of the following main Best Practices pillars: • Identify the conceptual framework of the subject of the dissemination • Increase personal awareness of the individual potential • Easy personal elaboration and the connection of the subject with the school curriculum.

  13. Good Teachers and Deviant Learners? The Meeting of Practices in University Level International Education

    ERIC Educational Resources Information Center

    Tange, Hanne; Jensen, Iben

    2012-01-01

    The article focuses on the impact of internationalization on university lecturers' practice. Based on interviews with 36 employees from Danish universities, we discuss what internationalization means for the classroom relationship between university teachers and international students. The article is inspired by an intercultural communication…

  14. Beyond "It Was Good": Students' Post-Study Abroad Practices for Negotiating Meaning

    ERIC Educational Resources Information Center

    Kortegast, Carrie A.; Boisfontaine, M. Terral

    2015-01-01

    Student participation in short-term study abroad programs has increased at a rapid pace; however, little is known about students' post--study abroad practices regarding negotiating meaning of their experiences. The purpose of this study is to explore students' post-study abroad participation and reification of their experiences using the…

  15. Good Images, Effective Messages? Working with Students and Educators on Academic Practice Understanding

    ERIC Educational Resources Information Center

    Gannon-Leary, Pat; Trayhurn, Deborah; Home, Margaret

    2009-01-01

    Work at Northumbria University has focussed on activity that extends opportunities for students to engage directly with the skills development necessary for sound academic practice. This has included highly visual campaigns on the "Plagiarism trap", providing access to Turnitin plagiarism detection software, guides and sessions to highlight use of…

  16. Effective Superintendent-School Board Practices: Strategies for Developing and Maintaining Good Relationships with Your Board

    ERIC Educational Resources Information Center

    Townsend, Rene S.; Johnston, Gloria L.; Gross, Gwen E.; Lynch, Peggy; Garcy, Lorraine M.; Roberts, Benita B.; Novotney, Patricia B.

    2006-01-01

    Foster a strong superintendent-school board relationship centered on quality teaching and learning! This book helps current and future superintendents and school board members develop an effective governance team that prioritizes quality teaching and learning. Designed for practicing and aspiring superintendents and school board members, this…

  17. The advanced practice professionals' perspective: keys to a good working relationship between advanced practice professions and physicians.

    PubMed

    Polansky, Maura

    2013-01-01

    A strong working relationship between advanced practice professionals (APPs) and supervising oncologists is essential for reducing medical errors, retaining employees, and improving work environments. Although there is rather limited data on the unique relationship of the APP and physician, fundamental communication skills-including open communication, mutual respect, establishing expectations, and working with mutual purpose-should be the foundation of these relationships. This paper addresses various aspects of relationship building between APPs and physicians with suggestions for establishing successful working relationships. PMID:23714552

  18. Good practice in social care: the views of people with severe and complex needs and those who support them.

    PubMed

    Gridley, Kate; Brooks, Jenni; Glendinning, Caroline

    2014-11-01

    This paper reports findings drawn from a study of good practice in English social care for adults with disability and older people with severe and complex needs. People with severe and complex needs are a relatively small proportion of adult social care service users, but they are growing in numbers and have resource-intensive needs. The study involved qualitative research with adults with disability and older people with severe and complex needs, family carers and members of specialist organisations (n = 67), focusing on the features of social care services they considered to be good practice. Data were collected between August 2010 and June 2011. The approach to data collection was flexible, to accommodate participants' communication needs and preferences, including face-to-face and telephone interviews, Talking Mats(©) sessions and a focus group. Data were managed using Framework and analysed thematically. Features of good practice were considered at three levels: (i) everyday support; (ii) service organisation; and (iii) commissioning. Findings relating to the first two of these are presented here. Participants emphasised the importance of person-centred ways of working at all levels. Personalisation, as currently implemented in English social care, aims to shift power from professionals to service users through the allocation of personal budgets. This approach focuses very much on the role of the individual in directing his/her own support arrangements. However, participants in this study also stressed the importance of ongoing professional support, for example, from a specialist key worker or case manager to co-ordinate diverse services and ensure good practice at an organisational level. The paper argues that, despite the recent move to shift power from professionals to service users, people with the most complex needs still value support from professionals and appropriate organisational support. Without these, they risk being excluded from the benefits

  19. Good practice in social care: the views of people with severe and complex needs and those who support them.

    PubMed

    Gridley, Kate; Brooks, Jenni; Glendinning, Caroline

    2014-11-01

    This paper reports findings drawn from a study of good practice in English social care for adults with disability and older people with severe and complex needs. People with severe and complex needs are a relatively small proportion of adult social care service users, but they are growing in numbers and have resource-intensive needs. The study involved qualitative research with adults with disability and older people with severe and complex needs, family carers and members of specialist organisations (n = 67), focusing on the features of social care services they considered to be good practice. Data were collected between August 2010 and June 2011. The approach to data collection was flexible, to accommodate participants' communication needs and preferences, including face-to-face and telephone interviews, Talking Mats(©) sessions and a focus group. Data were managed using Framework and analysed thematically. Features of good practice were considered at three levels: (i) everyday support; (ii) service organisation; and (iii) commissioning. Findings relating to the first two of these are presented here. Participants emphasised the importance of person-centred ways of working at all levels. Personalisation, as currently implemented in English social care, aims to shift power from professionals to service users through the allocation of personal budgets. This approach focuses very much on the role of the individual in directing his/her own support arrangements. However, participants in this study also stressed the importance of ongoing professional support, for example, from a specialist key worker or case manager to co-ordinate diverse services and ensure good practice at an organisational level. The paper argues that, despite the recent move to shift power from professionals to service users, people with the most complex needs still value support from professionals and appropriate organisational support. Without these, they risk being excluded from the benefits

  20. Emissions of dioxins and furans from garbage-burning incinerators can be minimized by good combustion practices

    SciTech Connect

    Not Available

    1987-10-01

    The American Society of Mechanical Engineers (ASME) have stated that emissions of dioxin and furan from garbage-burning incinerators can be minimized by good combustion practices. They have found that maintaining the heat of combustion above 815 degrees centigrade and reducing the carbon monoxide level to below 100 ppm will reduce the emissions of furan and dioxin. The combustion research that lead to these conclusions was sponsored by ASME and the New York energy authority

  1. Self-Assessed Competency at Working with a Medical Interpreter Is Not Associated with Knowledge of Good Practice

    PubMed Central

    Hudelson, Patricia; Perneger, Thomas; Kolly, Véronique; Junod Perron, Noëlle

    2012-01-01

    Background 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. Purposes 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. Methods A mailed questionnaire was sent to 619 doctors and medical students in Geneva, Switzerland. Results 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. Conclusions 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. PMID:22715421

  2. Good practice models for public workplace health promotion projects in Austria: promoting mental health.

    PubMed

    Burkert, Nathalie T; Muckenhuber, Johanna; Großschädl, Franziska; Sprenger, Martin; Rohrauer-Näf, Gerlinde; Ropin, Klaus; Martinel, Evelyn; Dorner, Thomas

    2014-04-01

    Promoting mental health is a central public health issue since the Jakarta statement in 1997. In Austria, the nationwide organisation for health promotion is the 'Fonds Gesundes Österreich' (FGÖ), which has been established in 1998. The FGÖ funds and supports workplace health promotion projects; therefore, it co-operates with the Austrian Network on Workplace Health Promotion. In 2011, among others, two Austrian companies were honoured as best practice models for promoting mental health in the project 'Work. In tune with life. Move Europe'. One of their central key success factors are the provision of equal opportunities, engagement, their focus on overall health as well as the implementation of behavioural and environmental preventive measures. Since mental health problems in the population are still rising, public health promotion projects which orientate on the best practice models have to be established in Austria. PMID:24327008

  3. [Manual for the design of non-drug trials in primary care, taking account of Good Clinical Practice (GCP) criteria].

    PubMed

    Joos, Stefanie; Bleidorn, Jutta; Haasenritter, Jörg; Hummers-Pradier, Eva; Peters-Klimm, Frank; Gágyor, Ildikó

    2013-01-01

    In recent years studies not falling under the German Pharmaceutical Law ("non-drug trials") have also been increasingly expected to be conducted according to Good Clinical Practice (GCP) in order to ensure that uniform standards are maintained for data quality and patient safety. However, simple transfer of the GCP criteria is not always possible and often not useful. Given the fact that research questions regarding non-drug interventions are common in primary care (e.g., general practice), the "Network for Clinical Studies in General Practice" has developed a manual for planning and conducting non-drug trials. This manual is based on the GCP guideline, taking account of the conditions and circumstances in primary care settings. Both structure and relevant content of the manual are presented in the article. (As supplied by the authors).

  4. Promoting Good Clinical Laboratory Practices and Laboratory Accreditation to Support Clinical Trials in Sub-Saharan Africa

    PubMed Central

    Shott, Joseph P.; Saye, Renion; Diakité, Moussa L.; Sanogo, Sintry; Dembele, Moussa B.; Keita, Sekouba; Nagel, Mary C.; Ellis, Ruth D.; Aebig, Joan A.; Diallo, Dapa A.; Doumbo, Ogobara K.

    2012-01-01

    Laboratory capacity in the developing world frequently lacks quality management systems (QMS) such as good clinical laboratory practices, proper safety precautions, and adequate facilities; impacting the ability to conduct biomedical research where it is needed most. As the regulatory climate changes globally, higher quality laboratory support is needed to protect study volunteers and to accurately assess biological parameters. The University of Bamako and its partners have undertaken a comprehensive QMS plan to improve quality and productivity using the Clinical and Laboratory Standards Institute standards and guidelines. The clinical laboratory passed the College of American Pathologists inspection in April 2010, and received full accreditation in June 2010. Our efforts to implement high-quality standards have been valuable for evaluating safety and immunogenicity of malaria vaccine candidates in Mali. Other disease-specific research groups in resource-limited settings may benefit by incorporating similar training initiatives, QMS methods, and continual improvement practices to ensure best practices. PMID:22492138

  5. 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.

  6. International survey for good practices in forecasting uncertainty assessment and communication

    NASA Astrophysics Data System (ADS)

    Berthet, Lionel; Piotte, Olivier

    2014-05-01

    Achieving technically sound flood forecasts is a crucial objective for forecasters but remains of poor use if the users do not understand properly their significance and do not use it properly in decision making. One usual way to precise the forecasts limitations is to communicate some information about their uncertainty. Uncertainty assessment and communication to stakeholders are thus important issues for operational flood forecasting services (FFS) but remain open fields for research. French FFS wants to publish graphical streamflow and level forecasts along with uncertainty assessment in near future on its website (available to the greater public). In order to choose the technical options best adapted to its operational context, it carried out a survey among more than 15 fellow institutions. Most of these are providing forecasts and warnings to civil protection officers while some were mostly working for hydroelectricity suppliers. A questionnaire has been prepared in order to standardize the analysis of the practices of the surveyed institutions. The survey was conducted by gathering information from technical reports or from the scientific literature, as well as 'interviews' driven by phone, email discussions or meetings. The questionnaire helped in the exploration of practices in uncertainty assessment, evaluation and communication. Attention was paid to the particular context within which every insitution works, in the analysis drawn from raw results. Results show that most services interviewed assess their forecasts uncertainty. However, practices can differ significantly from a country to another. Popular techniques are ensemble approaches. They allow to take into account several uncertainty sources. Statistical past forecasts analysis (such as the quantile regressions) are also commonly used. Contrary to what was expected, only few services emphasize the role of the forecaster (subjective assessment). Similar contrasts can be observed in uncertainty

  7. New Zealand National GDM Guidelines: an alternative view of some good practice points.

    PubMed

    Rowan, Janet; Allen, Helen; Budden, Astrid; Elder, Rose; Farrant, Matthew; Hughes, Ruth; Ivanova, Valeria; Moore, Peter; Marnoch, Catherine; McGrath, Nicole

    2015-02-01

    The New Zealand Gestational Diabetes Mellitus (GDM) Guidelines, commissioned by the Ministry of Health, contains many good points, but several recommendations are creating controversy. This opinion piece discusses an alternative approach to early pregnancy screening for diabetes. We suggest that it is reasonable to refer women with an HbA1c ≥41 mmol/mol (5.9%) for further management, rather than the recommended referral threshold of ≥50 mmol/mol (6.7%). We also suggest that, for subsequent screening for GDM at 24-28 weeks' gestation, a 75 g oral glucose tolerance test should be offered rather than a 50 g glucose challenge test.

  8. Low-cost risk reduction strategy for small workplaces: how can we spread good practices?

    PubMed

    Kogi, K

    2006-01-01

    Recent advances in health risk reduction approaches are examined based on inter-country networking experiences. A noteworthy progress is the wider application of low-cost improvements to risk reduction particularly in small enterprises and agriculture in both industrially developing and developed countries. This is helped by the readiness of managers and workers to implement these improvements despite many constraints. Typical improvements include mobile racks, simple workstation changes, screening hazards, better welfare facilities and teamwork arrangements. In view of the complex circumstances of work-related health risks, it is important to know whether a low-cost strategy can advance risk reduction practices effectively and what support measures are necessary. It is confirmed that the strategy can overcome related constraints through its advantages. Main advantages lie in (a) the facilitation of improved practices in multiple technical areas, (b) the strengthening of realistic stepwise risk reduction, and (c) the enhanced multiplier effects through training of local trainers. Action-oriented risk assessment tools, such as action checklists and low-cost improvement guides, can encourage risk-reducing measures adjusted to each local situation. It is suggested to spread the low-cost risk reduction strategy for improving small workplaces in diversified settings with the support of these locally tailored tools.

  9. Good practices for prone positioning at the bedside: Construction of a care protocol.

    PubMed

    Oliveira, Vanessa Martins de; Weschenfelder, Michele Elisa; Deponti, Gracieli; Condessa, Robledo; Loss, Sergio Henrique; Bairros, Patrícia Maurello; Hochegger, Thais; Daroncho, Rogério; Rubin, Bibiana; Chisté, Marcele; Batista, Danusa Cassiana Rigo; Bassegio, Deise Maria; Nauer, Wagner da Silva; Piekala, Daniele Martins; Minossi, Silvia Daniela; Santos, Vanessa Fumaco da Rosa Dos; Victorino, Josue; Vieira, Silvia Regina Rios

    2016-01-01

    Last year, interest in prone positioning to treat acute respiratory distress syndrome (ARDS) resurfaced with the demonstration of a reduction in mortality by a large randomized clinical trial. Reports in the literature suggest that the incidence of adverse events is significantly reduced with a team trained and experienced in the process. The objective of this review is to revisit the current evidence in the literature, discuss and propose the construction of a protocol of care for these patients. A search was performed on the main electronic databases: Medline, Lilacs and Cochrane Library. Prone positioning is increasingly used in daily practice, with properly trained staff and a well established care protocol are essencial. PMID:27310555

  10. Percutaneous coronary intervention in the UK: recommendations for good practice 2015

    PubMed Central

    Banning, Adrian P; Baumbach, Andreas; Blackman, Dan; Curzen, Nick; Devadathan, Sen; Fraser, Douglas; Ludman, Peter; Norell, Micheal; Muir, Dougie; Nolan, James; Redwood, Simon

    2015-01-01

    Over the last 35 years, there has been dramatic progress in the technology and applicability of percutaneous techniques to treat obstructive coronary heart disease. Percutaneous coronary intervention (PCI) has a considerable evidence base and it is firmly established as the most common procedure used in the invasive treatment of patients with coronary heart disease in the UK. This set of guidelines aims to address specifically issues relating to PCI and not the growing subspecialty of structural heart disease intervention. It is not intended to provide a review of the entire evidence base for coronary intervention. The evidence base relating to PCI is extensively reviewed in international guidelines and the British Cardiovascular Intervention society endorses these guidelines and their updates. The guidelines presented here focus on issues pertinent to practice within the UK and set out a recommended template to ensure optimal delivery of patient care. PMID:26041756

  11. The Australian Medical Council draft code of professional conduct: good practice or creeping authoritarianism?

    PubMed

    Komesaroff, Paul A; Kerridge, Ian H

    2009-02-16

    In preparation for a national medical registration system, the Australian Medical Council has proposed a code of conduct ("the Code") that provides a comprehensive description of how doctors should behave. While containing much that will be widely acceptable to doctors, the Code has some major weaknesses: Many of its provisions focus on values and aspirations of a very general nature and will be impossible to enforce. It is based on a narrow, culturally specific view of medicine and ethics that does not reflect the multicultural diversity of Australian society. It confuses the roles of ethics and law in medicine, leading to inappropriate and mistaken injunctions about decision making and responsibilities. In place of the existing, effective, democratic and devolved (if imperfect) system of ethical and professional decision making, it threatens to establish a centralised, authoritarian regime. Because of its limited, ideological view of medicine, its implementation would impoverish medical practice and erode the ability to respond to individual circumstances and needs. PMID:19220187

  12. Access to and value of information to support good practice for staff in Kenyan hospitals

    PubMed Central

    Muinga, Naomi; Sen, Barbara; Ayieko, Philip; Todd, Jim; English, Mike

    2015-01-01

    Background Studies have sought to define information needs of health workers within very specific settings or projects. Lacking in the literature is how hospitals in low-income settings are able to meet the information needs of their staff and the use of information communication technologies (ICT) in day-to-day information searching. Objective The study aimed to explore where professionals in Kenyan hospitals turn to for work-related information in their day-to-day work. Additionally, it examined what existing solutions are provided by hospitals with regard to provision of best practice care. Lastly, the study explored the use of ICT in information searching. Design Data for this study were collected in July 2012. Self-administered questionnaires (SAQs) were distributed across 22 study hospitals with an aim to get a response from 34 health workers per hospital. Results SAQs were collected from 657 health workers. The most popular sources of information to guide work were fellow health workers and printed guidelines while the least popular were scientific journals. Of value to health workers were: national treatment policies, new research findings, regular reports from surveillance data, information on costs of services and information on their performance of routine clinical tasks; however, hospitals only partially met these needs. Barriers to accessing information sources included: ‘not available/difficult to get’ and ‘difficult to understand’. ICT use for information seeking was reported and with demographic specific differences noted from the multivariate logistic regression model; nurses compared to medical doctors and older workers were less likely to use ICT for health information searching. Barriers to accessing Internet were identified as: high costs and the lack of the service at home or at work. Conclusions Hospitals need to provide appropriate information by improving information dissemination efforts and providing an enabling environment that

  13. Barriers and enablers to good communication and information-sharing practices in care planning for chronic condition management.

    PubMed

    Lawn, Sharon; Delany, Toni; Sweet, Linda; Battersby, Malcolm; Skinner, Timothy

    2015-01-01

    Our aim was to document current communication and information-sharing practices and to identify the barriers and enablers to good practices within the context of care planning for chronic condition management. Further aims were to make recommendations about how changes to policy and practice can improve communication and information sharing in primary health care. A mixed-method approach was applied to seek the perspectives of patients and primary health-care workers across Australia. Data was collected via interviews, focus groups, non-participant observations and a national survey. Data analysis was performed using a mix of thematic, discourse and statistical approaches. Central barriers to effective communication and information sharing included fragmented communication, uncertainty around client and interagency consent, and the unacknowledged existence of overlapping care plans. To be most effective, communication and information sharing should be open, two-way and inclusive of all members of health-care teams. It must also only be undertaken with the appropriate participant consent, otherwise this has the potential to cause patients harm. Improvements in care planning as a communication and information-sharing tool may be achieved through practice initiatives that reflect the rhetoric of collaborative person-centred care, which is already supported through existing policy in Australia. General practitioners and other primary care providers should operationalise care planning, and the expectation of collaborative and effective communication of care that underpins it, within their practice with patients and all members of the care team. To assist in meeting these aims, we make several recommendations.

  14. Making sense of how physician preceptors interact with medical students: discourses of dialogue, good medical practice, and relationship trajectories.

    PubMed

    van der Zwet, J; Dornan, T; Teunissen, P W; de Jonge, L P J W M; Scherpbier, A J J A

    2014-03-01

    Work based learning and teaching in health care settings are complex and dynamic. Sociocultural theory addresses this complexity by focusing on interaction between learners, teachers, and their environment as learners develop their professional identity. Although social interaction between doctors and students plays a crucial role in this developmental process, socio-cultural research from the perspective of doctors is scarce. We performed discourse analysis on seven general practitioners' audio diaries during a 10-week general practice clerkship to study how they gave shape to their interaction with their students. Examination of 61 diary-entries revealed trajectories of developing relationships. These trajectories were initiated by the way respondents established a point of departure, based on their first impression of the students. It continued through the development of dialogue with their student and through conceptualizations of good medical practice. Such conceptualizations about what was normal in medical and educational practice enabled respondents to recognize qualities in the student and to indirectly determine students' desired learning trajectory. Towards the end, discursive turns in respondents' narratives signaled development within the relationship. This became evident in division of roles and positions in the context of daily practice. Although respondents held power in the relationships, we found that their actions depended strongly on what the students afforded them socially. Our findings address a gap in literature and could further inform theory and practice, for example by finding out how to foster constructive dialogue between doctors and students, or by exploring different discourses among learners and teachers in other contexts. PMID:23771397

  15. Making sense of how physician preceptors interact with medical students: discourses of dialogue, good medical practice, and relationship trajectories.

    PubMed

    van der Zwet, J; Dornan, T; Teunissen, P W; de Jonge, L P J W M; Scherpbier, A J J A

    2014-03-01

    Work based learning and teaching in health care settings are complex and dynamic. Sociocultural theory addresses this complexity by focusing on interaction between learners, teachers, and their environment as learners develop their professional identity. Although social interaction between doctors and students plays a crucial role in this developmental process, socio-cultural research from the perspective of doctors is scarce. We performed discourse analysis on seven general practitioners' audio diaries during a 10-week general practice clerkship to study how they gave shape to their interaction with their students. Examination of 61 diary-entries revealed trajectories of developing relationships. These trajectories were initiated by the way respondents established a point of departure, based on their first impression of the students. It continued through the development of dialogue with their student and through conceptualizations of good medical practice. Such conceptualizations about what was normal in medical and educational practice enabled respondents to recognize qualities in the student and to indirectly determine students' desired learning trajectory. Towards the end, discursive turns in respondents' narratives signaled development within the relationship. This became evident in division of roles and positions in the context of daily practice. Although respondents held power in the relationships, we found that their actions depended strongly on what the students afforded them socially. Our findings address a gap in literature and could further inform theory and practice, for example by finding out how to foster constructive dialogue between doctors and students, or by exploring different discourses among learners and teachers in other contexts.

  16. Good practice recommendations for paediatric outpatient parenteral antibiotic therapy (p-OPAT) in the UK: a consensus statement.

    PubMed

    Patel, Sanjay; Abrahamson, Ed; Goldring, Stephen; Green, Helen; Wickens, Hayley; Laundy, Matt

    2015-02-01

    There is compelling evidence to support the rationale for managing children on intravenous antimicrobial therapy at home whenever possible, including parent and patient satisfaction, psychological well-being, return to school/employment, reductions in healthcare-associated infection and cost savings. As a joint collaboration between the BSAC and the British Paediatric Allergy, Immunity and Infection Group, we have developed good practice recommendations to highlight good clinical practice and governance within paediatric outpatient parenteral antibiotic therapy (p-OPAT) services across the UK. These guidelines provide a practical approach for safely delivering a p-OPAT service in both secondary care and tertiary care settings, in terms of the roles and responsibilities of members of the p-OPAT team, the structure required to deliver the service, identifying patients and pathologies that are suitable for p-OPAT, ensuring appropriate vascular access, antimicrobial choice and delivery and the clinical governance aspects of delivering a p-OPAT service. The process of writing a business case to support the introduction of a p-OPAT service is also addressed.

  17. [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

    Antecedentes: La Elaboración de fórmulas enterales está sujeta a diversos riesgos de contaminación. La Organización Mundial de la Salud (OMS) y la Organización para la Alimentación y la Agricultura (FAO) han emitido alertas y recomendaciones para su prevención, sugiriendo la estandarización y protocolización de todos los procedimientos involucrados. Objetivo: Elaborar y evaluar el cumplimiento de los criterios técnicos de una Pauta de Verificación de Buenas Prácticas de Manufactura, con relación a elaboración, conservación y administración de fórmulas enterales en hospitales de la provincia de Santiago. Material y métodos: Los criterios de verificación consideraron Planta Física, Equipamiento e Implementación, Normas Higiénicas y Sanitarias, Recurso Humano, Organización y Administración, Garantía de Inocuidad y Aseguramiento de la Calidad. Se definieron 639 criterios, 309 de Riesgo Tipo 1, por mayor riesgo de producir contaminación. El estudio se hizo por observación de las Unidades de Central de Fórmulas Enterales y entrevista con el profesional encargado. Se analizó la mediana de cumplimiento de cada grupo de criterios de riesgo tipo 1 y total. Resultados: Se evaluaron públicos 14 hospitales. El grado de cumplimiento de los 639 alcanzó una mediana de 33,2% (p25-75 31,6% -40,4%), con el valor más bajo para planta física con 27,9% (p25-75 23,9% -38,2%) y el mayor para recurso humano con 52,4% (p25-75 44,1%-52,4%). La mediana de grado de cumplimiento para Criterios Riesgo Tipo 1, fue sólo de 31,8% (p25-75 27,5% - 41,2%). Conclusión: La mayoría de las Unidades evaluadas, cumple con menos de la mitad de las recomendaciones internacionales o del Ministerio de Salud de Chile. Se deben elaborar protocolos y capacitar al personal para asegurar la calidad e inocuidad en la elaboración de fórmulas enterales y reducir los riesgos de infección.

  18. 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

    ... Access to the Analyses XVII. Paperwork Reduction Act of 1995 XVIII. Analysis of Environmental Impact XIX... Controls XVI. Preliminary Regulatory Impact Analysis A. Overview B. Regulatory Flexibility Act C. Small... Significantly Minimize or Prevent the Potential for an Environmental Pathogen To Contaminate Food E. Role...

  19. A Good Manufacturing Practice procedure to engineer donor virus-specific T cells into potent anti-leukemic effector cells

    PubMed Central

    van Loenen, Marleen M.; de Boer, Renate; van Liempt, Ellis; Meij, Pauline; Jedema, Inge; Falkenburg, J.H. Frederik; Heemskerk, Mirjam H.M.

    2014-01-01

    A sequential, two-step procedure in which T-cell-depleted allogeneic stem cell transplantation is followed by treatment with donor lymphocyte infusion at 6 months can significantly reduce the risk and severity of graft-versus-host disease, with postponed induction of the beneficial graft-versus-leukemia effect. However, patients with high-risk leukemia have a substantial risk of relapse early after transplantation, at a time when administration of donor lymphocytes has a high likelihood of resulting in graft-versus-host disease, disturbing a favorable balance between the graft-versus-leukemia effect and graft-versus-host disease. New therapeutic modalities are, therefore, required to allow early administration of T cells capable of exerting a graft-versus-leukemia effect without causing graft-versus-host disease. Here we describe the isolation of virus-specific T cells using Streptamer-based isolation technology and subsequent transfer of the minor histocompatibility antigen HA-1-specific T-cell receptor using retroviral vectors. Isolation of virus-specific T cells and subsequent transduction with HA-1-T-cell receptor resulted in rapid in vitro generation of highly pure, dual-specific T cells with potent anti-leukemic reactivity. Due to the short production procedure of only 10–14 days and the defined specificity of the T cells, administration of virus-specific T cells transduced with the HA-1-T-cell receptor as early as 8 weeks after allogeneic stem cell transplantation is feasible. (This clinical trial is registered at www.clinicaltrialsregister.eu as EudraCT number 2010-024625-20). PMID:24334296

  20. 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

    ... the notice of proposed rulemaking that appeared in the Federal Register of January 16, 2013 (78 FR... INFORMATION: I. Background In the Federal Register of January 16, 2013 (78 FR 3646), FDA published a proposed... FR 48636), to ] comment on the proposed rule and its information collection provisions. II....

  1. 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

    ... rule. DATES: The comment period for the proposed rule published January 16, 2013, at 78 FR 3646, is..., extended February 19, 2013, at 78 FR 11611, is further extended. Submit either electronic or written... INFORMATION: I. Background In the Federal Register of January 16, 2013 (78 FR 3646), we published a...

  2. 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

    ... the proposed rule: Jenny Scott, Center for Food Safety and Applied Nutrition (HFS-300), Food and Drug... the Federal Register of January 16, 2013 (78 FR 3646), we published a proposed rule entitled ``Current..., 2013, 78 FR 11611). FDA continued to receive comments requesting an extension of the comment period...

  3. 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

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND...-353) was signed into law by President Obama on January 4, 2011, to better protect public health by... address Address Other information College Park, MD, Public November 21, This meeting will be...

  4. 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

    ..., packing, or holding of human food (34 FR 6977). The CGMP regulation established criteria for effective... filth, or whereby it may have been rendered injurious to health (33 FR 19023, December 20, 1968). In... levels in foods. (38 FR 854, January 5, 1973). In 1977, we redesignated the CGMP regulation as part...

  5. A Good Manufacturing Practice procedure to engineer donor virus-specific T cells into potent anti-leukemic effector cells.

    PubMed

    van Loenen, Marleen M; de Boer, Renate; van Liempt, Ellis; Meij, Pauline; Jedema, Inge; Falkenburg, J H Frederik; Heemskerk, Mirjam H M

    2014-04-01

    A sequential, two-step procedure in which T-cell-depleted allogeneic stem cell transplantation is followed by treatment with donor lymphocyte infusion at 6 months can significantly reduce the risk and severity of graft-versus-host disease, with postponed induction of the beneficial graft-versus-leukemia effect. However, patients with high-risk leukemia have a substantial risk of relapse early after transplantation, at a time when administration of donor lymphocytes has a high likelihood of resulting in graft-versus-host disease, disturbing a favorable balance between the graft-versus-leukemia effect and graft-versus-host disease. New therapeutic modalities are, therefore, required to allow early administration of T cells capable of exerting a graft-versus-leukemia effect without causing graft-versus-host disease. Here we describe the isolation of virus-specific T cells using Streptamer-based isolation technology and subsequent transfer of the minor histocompatibility antigen HA-1-specific T-cell receptor using retroviral vectors. Isolation of virus-specific T cells and subsequent transduction with HA-1-T-cell receptor resulted in rapid in vitro generation of highly pure, dual-specific T cells with potent anti-leukemic reactivity. Due to the short production procedure of only 10-14 days and the defined specificity of the T cells, administration of virus-specific T cells transduced with the HA-1-T-cell receptor as early as 8 weeks after allogeneic stem cell transplantation is feasible. (This clinical trial is registered at www.clinicaltrialsregister.eu as EudraCT number 2010-024625-20).

  6. Generation of Human Alloantigen-Specific Regulatory T Cells Under Good Manufacturing Practice-Compliant Conditions for Cell Therapy.

    PubMed

    Cheraï, Mustapha; Hamel, Yamina; Baillou, Claude; Touil, Soumia; Guillot-Delost, Maude; Charlotte, Frédéric; Kossir, Laila; Simonin, Ghislaine; Maury, Sébastien; Cohen, José L; Lemoine, François M

    2015-01-01

    Natural regulatory T cells (Tregs) may have a great therapeutic potential to induce tolerance in allogeneic cells and organ transplantations. In mice, we showed that alloantigen-specific Tregs (spe-Tregs) were more efficient than polyclonal Tregs (poly-Tregs) in controlling graft-versus-host disease (GVHD). Here we describe a clinical-grade compliant method for generating human spe-Tregs. Tregs were enriched from leukapheresis products with anti-CD25 immunomagnetic beads, primed twice by allogeneic mature monocyte-derived dendritic cells (mDCs), and cultured during 3 weeks in medium containing interleukin 2 (IL-2), IL-15, and rapamycin. After 3 weeks of culture, final cell products were expanded 8.3-fold from the initial CD25(+) purifications. Immunophenotypic analyses of final cells indicate that they were composed of 88 ± 2.6% of CD4(+) T cells, all expressing Treg-specific markers (FOXP3, Helios, GARP, LAP, and CD152). Spe-Tregs were highly suppressive in vitro and also in vivo using a xeno-GVHD model established in immunodeficient mice. The specificity of their suppressive activity was demonstrated on their ability to significantly suppress the proliferation of autologous effector T cells stimulated by the same mDCs compared to third-party mDCs. Our data provide evidence that functional alloantigen Tregs can be generated under clinical-grade compliant conditions. Taking into account that 130 × 10(6) CD25(+) cells can be obtained at large scale from standard leukapheresis, our cell process may give rise to a theoretical final number of 1 × 10(9) spe-Tregs. Thus, using our strategy, we can propose to prepare spe-Tregs for clinical trials designed to control HLA-mismatched GVHD or organ transplantation rejection.

  7. Chlorophyll fluorescence analysis: a guide to good practice and understanding some new applications.

    PubMed

    Murchie, E H; Lawson, T

    2013-10-01

    Chlorophyll fluorescence is a non-invasive measurement of photosystem II (PSII) activity and is a commonly used technique in plant physiology. The sensitivity of PSII activity to abiotic and biotic factors has made this a key technique not only for understanding the photosynthetic mechanisms but also as a broader indicator of how plants respond to environmental change. This, along with low cost and ease of collecting data, has resulted in the appearance of a large array of instrument types for measurement and calculated parameters which can be bewildering for the new user. Moreover, its accessibility can lead to misuse and misinterpretation when the underlying photosynthetic processes are not fully appreciated. This review is timely because it sits at a point of renewed interest in chlorophyll fluorescence where fast measurements of photosynthetic performance are now required for crop improvement purposes. Here we help the researcher make choices in terms of protocols using the equipment and expertise available, especially for field measurements. We start with a basic overview of the principles of fluorescence analysis and provide advice on best practice for taking pulse amplitude-modulated measurements. We also discuss a number of emerging techniques for contemporary crop and ecology research, where we see continual development and application of analytical techniques to meet the new challenges that have arisen in recent years. We end the review by briefly discussing the emerging area of monitoring fluorescence, chlorophyll fluorescence imaging, field phenotyping, and remote sensing of crops for yield and biomass enhancement.

  8. The good, the bad and the 'not so bad': reflecting on moral appraisal in practice.

    PubMed

    Begley, Ann Marie

    2011-03-01

    The aim of this study is to facilitate reflection on the moral merit of practitioners in various contexts. Insight is gained from Aristotelian and Kantian accounts of moral character and an original framework for reflection is presented as an adjunct to ethical theory and principles considered when appraising others. In relation to states of character, there is an irreconcilable difference between Kantian (deontic) and Aristotelian (aretaic) conceptions of the nature of full virtue (excellence of character), but at the same time it can be argued that in relation to practice their approaches complement each other. It is also argued that in relation to caring for the vulnerable, Aristotle's conception of full virtue is more compelling than Kant's. On the other hand, Kant's notion of self-serving action is important in nursing and it therefore needs to be considered when reflecting on professional conduct. The conclusion reached is that Aristotelian and Kantian accounts of character appraisal should be used in a combined approach to moral appraisal. This approach draws on the accounts of both philosophers and offers valuable insight into moral character, professional conduct and, in a more formal setting, fitness to practise. PMID:21281392

  9. The good, the bad and the 'not so bad': reflecting on moral appraisal in practice.

    PubMed

    Begley, Ann Marie

    2011-03-01

    The aim of this study is to facilitate reflection on the moral merit of practitioners in various contexts. Insight is gained from Aristotelian and Kantian accounts of moral character and an original framework for reflection is presented as an adjunct to ethical theory and principles considered when appraising others. In relation to states of character, there is an irreconcilable difference between Kantian (deontic) and Aristotelian (aretaic) conceptions of the nature of full virtue (excellence of character), but at the same time it can be argued that in relation to practice their approaches complement each other. It is also argued that in relation to caring for the vulnerable, Aristotle's conception of full virtue is more compelling than Kant's. On the other hand, Kant's notion of self-serving action is important in nursing and it therefore needs to be considered when reflecting on professional conduct. The conclusion reached is that Aristotelian and Kantian accounts of character appraisal should be used in a combined approach to moral appraisal. This approach draws on the accounts of both philosophers and offers valuable insight into moral character, professional conduct and, in a more formal setting, fitness to practise.

  10. 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…

  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. 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

  13. State-transition modeling: a report of the ISPOR-SMDM Modeling Good Research Practices Task Force--3.

    PubMed

    Siebert, Uwe; Alagoz, Oguzhan; Bayoumi, Ahmed M; Jahn, Beate; Owens, Douglas K; Cohen, David J; Kuntz, Karen M

    2012-01-01

    State-transition modeling is an intuitive, flexible, and transparent approach of computer-based decision-analytic modeling including both Markov model cohort simulation and individual-based (first-order Monte Carlo) microsimulation. Conceptualizing a decision problem in terms of a set of (health) states and transitions among these states, state-transition modeling is one of the most widespread modeling techniques in clinical decision analysis, health technology assessment, and health-economic evaluation. State-transition models have been used in many different populations and diseases, and their applications range from personalized health care strategies to public health programs. Most frequently, state-transition models are used in the evaluation of risk factor interventions, screening, diagnostic procedures, treatment strategies, and disease management programs. The goal of this article was to provide consensus-based guidelines for the application of state-transition models in the context of health care. We structured the best practice recommendations in the following sections: choice of model type (cohort vs. individual-level model), model structure, model parameters, analysis, reporting, and communication. In each of these sections, we give a brief description, address the issues that are of particular relevance to the application of state-transition models, give specific examples from the literature, and provide best practice recommendations for state-transition modeling. These recommendations are directed both to modelers and to users of modeling results such as clinicians, clinical guideline developers, manufacturers, or policymakers. PMID:22999130

  14. Utilization of the seven principles for good practice in undergraduate education in general chemistry by community college instructors

    NASA Astrophysics Data System (ADS)

    Panther Bishoff, Jennifer

    In recent years, higher education has undergone many changes. The advent of assessment, accountability, and a newfound focus on teaching have required faculty to examine how they are teaching. Administrators and faculty are beginning to recognize that learning is not a "one size fits all" enterprise. To this end, Chickering and Gamson developed an inventory that examined faculty utilization of the Seven Principles of Good Practice in Undergraduate Education. The seven principles included by the authors included faculty-student interaction, cooperative learning, active learning, giving prompt feedback, emphasizing time on task, communicating high expectations, and respecting diverse talents and ways of learning. It was determined by Chickering and Gamson, as well as many other researchers, that these seven principles were hallmarks of successful undergraduate education. Community colleges are important institutions to study, as many students begin their higher education at two-year colleges. Most students are also required to take one or more science classes for their general education requirements; therefore, many students must take at least one general chemistry course. Both community colleges and chemistry are rarely studied in literature, which makes this study important. Community college general chemistry instructors were surveyed using an online version of Chickering and Gamson's Faculty Inventory for the Seven Principles of Good Practice in Undergraduate Education. Responses were analyzed, and it was discovered that not only did instructors utilize the principles to a different extent, but there were also differences between genders as well as between the specific actions related to each principle.

  15. Caught between the global economy and local bureaucracy: the barriers to good waste management practice in South Africa.

    PubMed

    Godfrey, Linda; Scott, Dianne; Trois, Cristina

    2013-03-01

    Empirical research shows that good waste management practice in South Africa is not always under the volitional control of those tasked with its implementation. While intention to act may exist, external factors, within the distal and proximal context, create barriers to waste behaviour. In addition, these barriers differ for respondents in municipalities, private industry and private waste companies. The main barriers to implementing good waste management practice experienced by respondents in municipalities included insufficient funding for waste management and resultant lack of resources; insufficient waste knowledge; political interference in decision-making; a slow decision-making process; lack of perceived authority to act by waste staff; and a low priority afforded to waste. Barriers experienced by respondents in private industry included insufficient funding for waste and the resultant lack of resources; insufficient waste knowledge; and government bureaucracy. Whereas, barriers experienced in private waste companies included increasing costs; government bureaucracy; global markets; and availability of waste for recycling. The results suggest that respondents in public and private waste organizations are subject to different structural forces that shape, enable and constrain waste behaviour.

  16. Enrollment Challenges and "Best Practices" of Selected Two-Year College's Electronic and Manufacturing Programs

    ERIC Educational Resources Information Center

    Jones, Gwendolyn; Hall, Robert A.

    2007-01-01

    The primary purpose of the study was to identify successful electronic and manufacturing engineering programs at two-year colleges that Northeast Community College (a pseudonym) programs can be benched marked against. The project examined two-year college programs for increased enrollment and the number of graduates for the academic years 2000 to…

  17. Disseminating good practice.

    PubMed

    Roush, Karen

    2015-09-01

    COMMUNICATION IS a core competency for nurse executives. Being able to write well and share this writing through publication is essential to disseminate information, engender support and share a vision. PMID:26308996

  18. Compliance of disposal orbits with the French Space Operations Act: The Good Practices and the STELA tool

    NASA Astrophysics Data System (ADS)

    Le Fèvre, C.; Fraysse, H.; Morand, V.; Lamy, A.; Cazaux, C.; Mercier, P.; Dental, C.; Deleflie, F.; Handschuh, D. A.

    2014-01-01

    Space debris mitigation is one objective of the French Space Operations Act (FSOA), in line with Inter-Agency Space Debris Coordination Committee (IADC) recommendations, through the removal of non-operational objects from populated regions. At the end of their mission, space objects are to be placed on orbits that will minimize future hazards to space objects orbiting in the same region. The FSOA, which came into force in 2010, ensures that technical risks associated with space activities are properly mitigated. The Act confers CNES a central support role in providing technical expertise to government on regulations dealing with space operations. In order to address the compliance of disposal orbits with the law technical requirements, CNES draws up Good Practices as well as a dedicated tool, Semi-analytic Tool for End of Life Analysis (STELA). The verification of the criteria of the French Space Operations Act requires long term orbit propagation to evaluate the evolution of the orbital elements over long time scales (up to more than 100 years). The Good Practices define the minimum dynamical model required to compute the orbital evolution with sufficient accuracy, and detail key computation hypotheses such as drag and reflecting areas, drag coefficient, reflectivity coefficient, solar activity, atmospheric density model and so on. They also recommend a methodology adapted to each orbit type (LEO, GEO, GTO) to assess the criteria of the French Space Operations Act. The most recent works have concerned GTO, for which some couplings occur between dynamic perturbations. A small change in the initial conditions or in the estimation of the drag effect will significantly change the entrance conditions in resonance areas and thus the orbital evolution. To cope with this difficulty, a statistical method has been developed. This paper gives an overview of the Good Practices for orbit propagation in LEO, GEO and GTO as well as a brief description of the STELA tool. It

  19. A Case Study of Institutional Visioning, Public Good, and the Renewal of Democracy: The Theory and Practice of Public Good Work at the University of Denver

    ERIC Educational Resources Information Center

    Fretz, Eric; Cutforth, Nick; Nicotera, Nicole; Thompson, Sheila Summers

    2009-01-01

    In 2001, the University of Denver included language in its vision statement that committed the institution to becoming "a great private university dedicated to the public good." This essay (1) explains how the development of an institutional visioning statement led to the implementation of a series of campus dialogues and action steps designed to…

  20. 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. PMID:25830179

  1. 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.

  2. Manual of good practice for recycling/reuse of highway construction materials. Final report, December 1994-December 1995

    SciTech Connect

    Brogan, J.D.

    1996-02-01

    The purpose of this report is to develop a Manual of Good Practice for distribution to agencies (Primarily at the small city and county levels) involved in planning, designing, constructing, and (perhaps most importantly) maintaining highway and other transportation facilities in the State of New Mexico. This Manual will contain information on the various uses to which recycled paving and other highway construction materials and products may be out and would be distributed to appropriate State, Tribal and local personnel through the NMSH&TD`s Local Technical Assistance Program (LTAP). The Manual will address methods for making the materials available, agencies and organizations eligible to receive the material, and procedures to be followed to acquire the materials.

  3. Using the reference framework for good measles management in practice--a case study from North Rhine-Westphalia.

    PubMed

    Schröter, Matthias; Schröder-Bäck, Peter; Brand, Helmut

    2009-12-01

    In 2005, WHO Europe reconfirmed the objective of eradicating measles and fixed a strategy plan for the years 2005 up to 2010. While a downward trend of measles infections in Germany between 2001 and 2004 could be observed, as many as 780 cases of measles were reported in 2005 and in 2006 even 2.281 cases. These high figures in 2006 were almost exclusively caused by an outbreak in the German region of North Rhine-Westphalia. This case study describes how a reference framework for good health management of measles prevention was applied for this region. As a result, various recommendations for action could be given, among them the recommendation to implement individual vaccination reminder systems for parents and bonus systems for parents. Based on these results, a comprehensive policy concept has been drawn up and has become the subject of a political agreement process in this region. Thus this case study shows a paradigm how reference frameworks for good health management can be utilised in practice.

  4. 21 CFR 111.123 - What quality control operations are required for the master manufacturing record, the batch...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... the master manufacturing record, the batch production record, and manufacturing operations? 111.123 Section 111.123 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING,...

  5. A practical and scalable manufacturing process for an anti-fungal agent, Nikkomycin Z.

    PubMed

    Stenland, Christopher J; Lis, Lev G; Schendel, Frederick J; Hahn, Nicholas J; Smart, Mary A; Miller, Amy L; von Keitz, Marc G; Gurvich, Vadim J

    2013-02-15

    A scalable and reliable manufacturing process for Nikkomycin Z HCl on a 170 g scale has been developed and optimized. The process is characterized by a 2.3 g/L fermentation yield, 79% purification yield, and >98% relative purity of the final product. This method is suitable for further scale up and cGMP production. The Streptomyces tendae ΔNikQ strain developed during the course of this study is superior to any previously reported strain in terms of higher yield and purity of Nikkomycin Z. PMID:23440664

  6. Practical application of game theory based production flow planning method in virtual manufacturing networks

    NASA Astrophysics Data System (ADS)

    Olender, M.; Krenczyk, D.

    2016-08-01

    Modern enterprises have to react quickly to dynamic changes in the market, due to changing customer requirements and expectations. One of the key area of production management, that must continuously evolve by searching for new methods and tools for increasing the efficiency of manufacturing systems is the area of production flow planning and control. These aspects are closely connected with the ability to implement the concept of Virtual Enterprises (VE) and Virtual Manufacturing Network (VMN) in which integrated infrastructure of flexible resources are created. In the proposed approach, the players role perform the objects associated with the objective functions, allowing to solve the multiobjective production flow planning problems based on the game theory, which is based on the theory of the strategic situation. For defined production system and production order models ways of solving the problem of production route planning in VMN on computational examples for different variants of production flow is presented. Possible decision strategy to use together with an analysis of calculation results is shown.

  7. A Lesson Plan for the Enhancement of Training and Research in Academia by the Adaptation and Adoption of Good Laboratory Practice Guidelines

    ERIC Educational Resources Information Center

    Sitaraman, Ramakrishnan

    2010-01-01

    The implementation of good laboratory practices (GLPs) is recognized by the biotechnology and pharmaceutical industries as being critical for ensuring the international acceptability of products. However, as universities and colleges (and research organizations) do not necessarily work under similar constraints, actual laboratory practices vary…

  8. 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

    ... amount or redistribute budgeted funds by at least the differential established in 2 CFR 176.110(a). (3... 2 Grants and Agreements 1 2011-01-01 2011-01-01 false Award term-Required Use of American Iron... 2009 § 176.140 Award term—Required Use of American Iron, Steel, and Manufactured Goods—Section 1605...

  9. 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

    ... amount or redistribute budgeted funds by at least the differential established in 2 CFR 176.110(a). (3... 2 Grants and Agreements 1 2010-01-01 2010-01-01 false Award term-Required Use of American Iron... American Iron, Steel, and Manufactured Goods—Section 1605 of the American Recovery and Reinvestment Act...

  10. HIV / AIDS and employment code of good practice. Draft for the National Economic Development and Labour Council -August 1995.

    PubMed

    1995-11-01

    International labor standards dictate that human immunodeficiency virus (HIV) infection and acquired immunodeficiency syndrome (AIDS) be treated as any other life-threatening medical condition, with no undue burden placed on employees. Toward this end, South African human rights advocates have prepared an HIV/AIDS Employment Code of Good Practice for presentation to the National Economic Development and Labor Council. Moreover, it is being recommended that the Code be appended to the 1995 Labor Relations Act. The Code is expected to provide a basis for fair employment policy and a reference point for resolving disputes in the proposed Conciliation, Mediation, and Arbitration Commission. The Code prohibits pre-employment HIV screening and stipulates that HIV status cannot be used as a basis for denying training or promotion opportunities. Employees known to be HIV-positive shall be ensured confidentiality and provided with full access to employment benefits. When illness progresses to the point where an employee can no longer perform his or her duties, another more appropriate position should be located; if this is not possible, or if the employee is too ill to work, termination due to incapacity may be considered, but with the continuation of full company benefits. Mechanisms of redress should be identified for HIV-infected employees with discrimination-related grievances. The Code further mandates the provision of compulsory AIDS education programs to combat misinformation at the workplace. Disciplinary measures against an employee who refuses to work with an infected co-worker are sanctioned.

  11. Death knocks, professional practice, and the public good: the media experience of suicide reporting in New Zealand.

    PubMed

    Collings, Sunny C; Kemp, Christopher G

    2010-07-01

    Health, government, and media organizations around the world have responded to research demonstrating the imitative effects of suicide coverage in the news media by developing guidelines to foster responsible reporting. Implementation of these guidelines has encountered some resistance, and little is known about the media perspective on suicide coverage and its effects on guideline use. This qualitative study provides an in-depth appreciation of this perspective by investigating the experiences of journalists covering suicide in New Zealand. Fifteen newspaper, television and radio journalists were interviewed between December 2008 and March 2009 and transcripts were analyzed using a grounded hermeneutic editing approach. Five themes were identified: public responsibility, media framing of suicide, professional practice, personal experience of suicide reporting, and restricted reporting. Participants asserted the role of the media in the protection of the public good. Though this stance aligns them with the goals of health policymakers, it is derived from a set of professional mores at odds with the perceived paternalism of suicide reporting guidelines. Participants were stakeholders in the issue of suicide coverage. We conclude that policymakers must engage with the news media and acknowledge the competing imperatives that provide the context for the application of suicide reporting guidelines by individual journalists. Collaborative guideline development will be vital to effective implementation.

  12. Flame-based processing as a practical approach for manufacturing hydrogen evolution electrodes

    NASA Astrophysics Data System (ADS)

    Roller, Justin; Renner, Julie; Yu, Haoran; Capuano, Chris; Kwak, Tony; Wang, Yang; Carter, C. Barry; Ayers, Kathy; Mustain, William E.; Maric, Radenka

    2014-12-01

    Catalyst structure and morphology are inevitably dictated by the synthesis route, which in-turn dictates catalyst activity, stability and utilization in the electrode. Reactive spray deposition technology (RSDT) is a promising synthesis route for electrode manufacturing because of the potential to achieve high-throughput processing under a diverse range of process configurations. This work investigates several unique approaches to Pt catalyst deposition using jet-flame synthesis for water electrolysis electrodes. Direct application of the catalyst film onto Nafion 117 and carbon paper is explored along with approaches to dispersing the Pt onto carbon or TinO2n-1. Operational challenges relating to the harsh conditions of H2 evolution and electrode adhesion are addressed by adding binder and catalyst support to the electrode structure. The RSDT technology produces an electrode, coated directly onto Nafion 117®, with a 20-fold reduction in Pt loading while maintaining high in-cell performance (2.1 V at 2 A cm-2) compared to an industry-level baseline. Durability testing at 1.8 A cm-2, 400 psi differential pressure and a temperature of 50 °C yields a consistent potential of ∼2.2 V for over 1100 h without failure. The same electrode applied directly to carbon paper resulted in a voltage of ∼2.1 V for ∼600 h without failure.

  13. 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,...

  14. 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,...

  15. 21 CFR 606.171 - Reporting of product deviations by licensed manufacturers, unlicensed registered blood...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 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,...

  16. 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,...

  17. 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,...

  18. 21 CFR 111.355 - What are the design requirements for manufacturing operations?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 2 2011-04-01 2011-04-01 false What are the design requirements for manufacturing... HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process...

  19. 21 CFR 111.205 - What is the requirement to establish a master manufacturing record?

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 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 MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process...

  20. 21 CFR 111.355 - What are the design requirements for manufacturing operations?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 2 2012-04-01 2012-04-01 false What are the design requirements for manufacturing... HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process...