Science.gov

Sample records for good manufacture practices

  1. Highlights of Good Manufacturing Practice in Japan.

    PubMed

    Morita, K

    1990-01-01

    Good Manufacturing Practice (GMP) in the pharmaceutical industry originated in the United States. Japan, having absorbed many things from the U.S., is actively seeking to establish Good Manufacturing Practice to match the pharmaceutical manufacturing climate in Japan. Several of the themes which highlight Japanese GMP efforts are presented below.

  2. 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...

  3. 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...

  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, 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...

  6. 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...

  7. Good manufacturing practices and clinical supplies.

    PubMed

    Levchuk, J W

    1991-01-01

    Quality characteristics must be assured through adherence to good manufacturing practices in the production, control, and testing of drug products intended for investigational as well as commercial use. A draft guideline on the preparation of investigational new drug products, soon to be available in final form, addresses questions that have been raised regarding acceptable practices and procedures to facilitate compliance with the CGMP regulations as applied to clinical supplies. Inspections of sterile clinical supplies production can be expected to include the areas most likely to influence product safety, quality, and uniformity in the same manner as would be expected regarding the manufacture of commercial batches. Some areas of particular significance in the manufacture of parenteral clinical supplies include validation of terminal sterilization, aseptic processing, and oxygen exclusion. The validation of the aseptic handling during lyophilization requires special attention. Other CGMP concerns include the provision of a quality control unit, avoiding packaging mixups, and being prepared for an amendment to the CGMP regulations regarding terminal sterilization.

  8. 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...

  9. 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,...

  10. 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,...

  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, 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,...

  13. 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...

  14. 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,...

  15. 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...

  16. 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,...

  17. 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...

  18. 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,...

  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, 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,...

  1. 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,...

  2. 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,...

  3. 75 FR 78715 - Small Entity Compliance Guide: Current Good Manufacturing Practice in Manufacturing, Packaging...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-16

    ... HUMAN SERVICES Food and Drug Administration Small Entity Compliance Guide: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements; Availability...) is announcing the availability of a guidance entitled ``Current Good Manufacturing Practice...

  4. 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...

  5. 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...

  6. 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...

  7. 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,...

  8. 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...

  9. 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,...

  10. 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...

  11. 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,...

  12. 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,...

  13. 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,...

  14. 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.

  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, 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,...

  19. 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,...

  20. 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...

  1. 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...

  2. 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...

  3. 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...

  4. 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...

  5. Application of ISO 9002 and FDA's good manufacturing practices to general chemical manufacturing.

    PubMed

    Kauffman, J M; Weiler, E D

    1992-06-01

    Two manufacturing standards are discussed and compared, namely, the U.S. Food and Drug Administration's Good Manufacturing Practices and the International Standards Organization 9000 (ISO 9000) series. Conclusions are drawn relative to quality improvement strategies.

  6. 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.

  7. 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

  8. Current good manufacturing practice for positron emission tomography drugs.

    PubMed

    2009-12-10

    The Food and Drug Administration (FDA) is issuing regulations on current good manufacturing practice (CGMP) for positron emission tomography (PET) drugs. The regulations are intended to ensure that PET drugs meet the requirements of the Federal Food, Drug, and Cosmetic Act (the act) regarding safety, identity, strength, quality, and purity. In this final rule, we are establishing CGMP regulations for approved PET drugs. For investigational and research PET drugs, the final rule states that the requirement to follow CGMP may be met by complying with these regulations or by producing PET drugs in accordance with the United States Pharmacopeia (USP) general chapter on compounding PET radiopharmaceuticals. We are establishing these CGMP requirements for PET drugs under the provisions of the Food and Drug Administration Modernization Act of 1997 (the Modernization Act). Elsewhere in this issue of the Federal Register, we are announcing the availability of a guidance entitled "PET Drugs--Current Good Manufacturing Practice (CGMP)."

  9. 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...

  10. 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.

  11. 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.

  12. 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...

  13. 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...

  14. 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...

  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. 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...

  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. Copyright © 2015 by the American Society for Biochemistry and Molecular Biology, Inc.

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

    PubMed

    2007-06-25

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

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

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 4 2013-04-01 2013-04-01 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. 21 CFR 212.2 - What is current good manufacturing practice for PET drugs?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 4 2011-04-01 2011-04-01 false What is current good manufacturing practice for... 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...

  1. 21 CFR 212.2 - What is current good manufacturing practice for PET drugs?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

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

  2. 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...

  3. 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...

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

    PubMed

    Hiyama, Yukio

    2010-01-01

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

  5. Burn patient care lost in good manufacturing practices?

    PubMed Central

    Dimitropoulos, G.; Jafari, P.; de Buys Roessingh, A.; Hirt-Burri, N.; Raffoul, W.; Applegate, L.A.

    2016-01-01

    Summary Application of cell therapies in burn care started in the early 80s in specialized hospital centers world-wide. Since 2007, cell therapies have been considered as “Advanced Therapy Medicinal Products” (ATMP), so classified by European Directives along with associated Regulations by the European Parliament. Consequently, regulatory changes have transformed the standard linear clinical care pathway into a more complex one. It is important to ensure the safety of cellular therapies used for burn patients and to standardize as much as possible the cell sources and products developed using cell culture procedures. However, we can definitely affirm that concentrating the bulk of energy and resources on the implementation of Good Manufacturing Practice (GMP) alone will have a major negative impact on the care of severely burned patients world-wide. Developing fully accredited infrastructures and training personnel (required by the new directives), along with obtaining approval for clinical trials to go ahead, can be a lengthy process.We discuss whether or not these patients could benefit from cell therapies provided by standard in-hospital laboratories, thus avoiding having to meet rigid regulations concerning the use of industrial pharmaceutical products. “Hospital Exemption” could be a preferred means to offer burn patients a customized and safe product, as many adaptations may be required throughout their treatment pathway. Patients who are in need of rapid treatment will be the ones to suffer the most from regulations intended to help them. PMID:28149232

  6. Burn patient care lost in good manufacturing practices?

    PubMed

    Dimitropoulos, G; Jafari, P; de Buys Roessingh, A; Hirt-Burri, N; Raffoul, W; Applegate, L A

    2016-06-30

    Application of cell therapies in burn care started in the early 80s in specialized hospital centers world-wide. Since 2007, cell therapies have been considered as "Advanced Therapy Medicinal Products" (ATMP), so classified by European Directives along with associated Regulations by the European Parliament. Consequently, regulatory changes have transformed the standard linear clinical care pathway into a more complex one. It is important to ensure the safety of cellular therapies used for burn patients and to standardize as much as possible the cell sources and products developed using cell culture procedures. However, we can definitely affirm that concentrating the bulk of energy and resources on the implementation of Good Manufacturing Practice (GMP) alone will have a major negative impact on the care of severely burned patients world-wide. Developing fully accredited infrastructures and training personnel (required by the new directives), along with obtaining approval for clinical trials to go ahead, can be a lengthy process.We discuss whether or not these patients could benefit from cell therapies provided by standard in-hospital laboratories, thus avoiding having to meet rigid regulations concerning the use of industrial pharmaceutical products. "Hospital Exemption" could be a preferred means to offer burn patients a customized and safe product, as many adaptations may be required throughout their treatment pathway. Patients who are in need of rapid treatment will be the ones to suffer the most from regulations intended to help them.

  7. 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...

  8. 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...

  9. 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...

  10. 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...

  11. 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...

  12. 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

    ... HUMAN SERVICES Food and Drug Administration Guidance for Small Business Entities on Current Good... 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.''...

  13. 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.

  14. 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.

  15. Sterile devices: A GMP (Good Manufacturing Practices) workshop manual

    NASA Astrophysics Data System (ADS)

    Derision, R.; Lower, A.; Bimonte, R.

    1983-05-01

    The manual, which covers GMPs for sterilization processes, presents model procedures and forms as well as a variety of articles and reprints. It is a compilation of GMP materials that small device firms may find useful in understanding how some manufacturers have successfully compiled with the GMP requirements as they apply to the manufacture of sterile devices.

  16. 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.

  17. 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

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

    NASA Astrophysics Data System (ADS)

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

    2016-11-01

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

  19. 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.

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

    PubMed

    2016-11-18

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

  1. Implementation of Current Good Manufacturing Practices in a small research laboratory setting.

    PubMed

    Keller, C D; Taulbee, S M

    1995-03-01

    The Current Good Manufacturing Practice (cGMP) for Finished Pharmaceuticals as found in 21 CFR 211 is specifically geared to the regulation of drug-manufacturing processes in industry. However, under some circumstances, it becomes necessary to apply the regulation to manufacturing operations in a research laboratory setting. Application of the regulations in such a setting requires management commitment, cooperation between QA/QC and technical staff, patience, creativity, and an understanding of the spirit behind the letter of the law. Breaking down the regulations into their fundamental parts gives insight into the intent of the regulations and aids in their application. This article will outline our experience in applying the cGMP in a research laboratory setting.

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

    PubMed

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

    2013-03-01

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

  3. 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..., Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg....

  4. 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.

  5. Regulation of drugs and chemicals used by the poultry industry. Good manufacturing practices.

    PubMed

    Boyd, L H

    1994-09-01

    Good manufacturing practices (GMP) are required to be followed in the use of animal drugs to produce medicated feeds. The authority is found in the federal Food, Drug, and Cosmetic Act, which states that medicated feed can be deemed adulterated if GMP were not followed in its production. This authority has been translated into GMP regulations applicable to all medicated feed production. More detailed GMP are imposed on those using high potency sources of drugs that require a withdrawal period (Category II). Less detailed GMP are imposed on all other drug uses (Category I and lower potency sources of Category II). Facility registration, medicated feed applications, and biennial inspections are also imposed on those required to follow the more detailed GMP regulations. The basic thrust of the regulations is assurance that drug use is correct in all respects and that the integrity of all medicated and nonmedicated feeds is maintained. The objective is food free of illegal drug residues, i.e., food safety. The GMP regulations are based on joint industry-government endeavor and reflect the practical realities of feed manufacturing. They are, for all practical purposes, good business practices assuring that medicated feeds make a positive contribution to food production and consumer confidence.

  6. Design and operation of a current good manufacturing practices cell-engineering laboratory.

    PubMed

    Burger, S R

    2000-01-01

    Medical centers and biotechnology companies active in cellular and gene therapy increasingly are working to design and build clinical laboratories capable of performing cellular engineering and vector production using current good manufacturing practices (cGMPs). Because cell engineering is a rapidly changing field, and definitions for cell engineering cGMPs are still being established, a cGMP cell-engineering laboratory most often should be designed with a broad range of potential applications in mind. While the laboratory facility is the most tangible aspect of cGMP, it represents only part of a larger process, which it must be designed and built to support.

  7. Quality assurance and good manufacturing practices for processing hematopoietic progenitor cells.

    PubMed

    McCullough, J

    1995-12-01

    Hematopoietic progenitor cell processing is now only a part of somatic cell and gene therapy. As these new therapies become used increasingly, it is essential that the new products used to treat patients be as safe and effective as possible. Although progenitor cell processing is still an evolving activity, it is appropriate to introduce standardization and product and process control into the routine laboratory activities. Initial suggestions for quality assurance and good manufacturing practices to accomplish this are presented here. These will need to be modified as experience is gained with progenitor, somatic cell, and gene therapy.

  8. The 1941 sulfathiazole disaster and the birth of good manufacturing practices.

    PubMed

    Swann, J P

    1999-01-01

    The beginning of modern standards for good manufacturing practices can be traced to an incident that began in December 1940, when the Winthrop Chemical Company of New York put on the market sulfathiazole tablets contaminated with phenobarbital. Hundreds of deaths and injuries resulted. FDA's investigation into Winthrop's sulfathiazole production and the agency's efforts to retrieve the Winthrop drug remaining on the market revealed numerous control deficiencies in the plant and serious irregularities in the firm's attempt to recall the tainted tablets. The incident prompted FDA to require detailed controls in sulfathiazole production at Winthrop and throughout the industry, an approach that became the basis for production control standards for all pharmaceuticals.

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

    PubMed

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

    2016-09-01

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

  10. 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

    ... Manufacturing Practice and Hazard Analysis and Risk- Based Preventive Controls for Food for Animals; Public... proposed rule to establish requirements for current good manufacturing practice and hazard analysis and... that will establish the foundation of, and central framework for, the modern food safety system...

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

    PubMed

    2008-07-15

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

  12. 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

    ... 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, and... for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)''...

  13. 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.

  14. 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.

  15. Preparation of intravenous cholesterol tracer using current good manufacturing practices1[S

    PubMed Central

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

    2015-01-01

    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

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

    PubMed

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

    1999-12-01

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

  17. Vaccine industry perspective of current issues of good manufacturing practices regarding product inspections and stability testing.

    PubMed

    Monahan, T R

    2001-12-15

    I address 2 important topics of current good manufacturing practices as they apply to vaccine products: product inspections and stability testing. The perspective presented is that of regulated industry. There are 2 major categories of product/facility inspections: those occurring before licensure of a vaccine product and those occurring after a vaccine product is licensed. The logistics and focus of each inspection type, the preapproval inspection, and the required biennial inspection are discussed, as are guidance and recommendations for achieving successful inspections. The requirements, guidance, and recommendations regarding the type, amount, and extensiveness of stability data for vaccine products are presented. The discussion details the potential differences in the amount and type of data required for products that are not yet licensed versus marketed products. Guidance, from a regulated industry perspective, regarding the design and implementation of a successful stability program is also discussed.

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

    PubMed

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

    2017-09-09

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

  19. 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

  20. 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.

  1. 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.

  2. Amendment to the current good manufacturing practice regulations for finished pharmaceuticals. Direct final rule.

    PubMed

    2007-12-04

    The Food and Drug Administration (FDA) is amending certain regulations as the first phase of an incremental approach to modifying the current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. We are amending the regulations to modernize or clarify some of the CGMP requirements, as well as harmonize some of the CGMP requirements with those of other foreign regulators and other FDA regulations. These amendments are also consistent with current industry practice. We are taking this action as part of our continuing effort to revise outdated regulations without diminishing public health protection. We are issuing a direct final rule for this action because FDA expects there will be no significant adverse comments on these amendments. Elsewhere in this issue of the Federal Register, we are publishing a companion proposed rule, under our usual notice-and-comment rulemaking procedures, to provide a procedural framework to finalize the rule in the event the agency receives any significant adverse comments and withdraws this direct final rule. The companion proposed rule and direct final rule are substantively identical.

  3. From Skin Biopsy to Neurons Through a Pluripotent Intermediate Under Good Manufacturing Practice Protocols

    PubMed Central

    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

    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. PMID:23197638

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

    PubMed

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

    2012-01-01

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

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

    PubMed Central

    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

  6. Good manufacturing practices--grade preformed ossicular prostheses from banked bone via computer numerically controlled micromilling.

    PubMed

    Berrettini, Stefano; Bruschini, Luca; Stefanini, Cesare; D'Alessandro, Delfo; D'Acunto, Mario; Danti, Serena

    2011-01-01

    The aim of this study was the fabrication of ossicular replacement prostheses (ORPs) from decellularized banked cortical bone via computer numerically controlled (CNC) ultraprecision micromilling, in order to obtain preformed clinical-grade tissue products, reproducing shape, size, and details perfectly comparable to those of synthetic devices. Banked femoral compact bone was used to fabricate partial and total ORPs via CNC micromilling according to Good Manufacturing Practices procedures. Drawings of ORPs with different shapes and sizes were uploaded to the computer interface, and different surface-finish parameters were tested. The obtained products underwent dimensional, weight, and surface characterizations. A histologic analysis was pursued to compare the bone matrix compactness of the produced ORPs to that of the ear ossicles. Banked-bone ORPs were produced with high dimensional accuracy. Partial ORP weights averaged (+/- SD) 31.2 +/- 0.6 mg, and total ORP weights averaged 69.3 +/- 0.7 mg. The best-finish mode allowed microscale or nanoscale roughness free from machinery textures to be obtained. Finally, the histologic analysis confirmed that the extracellular matrix compactness of the produced ORPs was suitable for ossicular chain replacement. This study assesses the fabrication feasibility of novel banked-bone ORPs of extremely high dimensional accuracy. Such devices are aimed at combining the most favorable aspects of both synthetic (reproducibility, convenience, and biosafety) and biological replacements (total biocompatibility).

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

    PubMed

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

    2009-11-01

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

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

    PubMed Central

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

    2009-01-01

    Aim: To prepare a clinical-grade anti-caries DNA vaccine pGJA-P/VAX and explore its immune effect and protective efficacy against a cariogenic bacterial challenge. Methods: A large-scale industrial production process was developed under Good Manufacturing Practices (GMP) by combining and optimizing common unit operations such as alkaline lysis, precipitation, endotoxin removal and column chromatography. Quality controls of the purified bulk and final lyophilized vaccine were conducted according to authoritative guidelines. Mice and gnotobiotic rats were intranasally immunized with clinical-grade pGJA-P/VAX with chitosan. Antibody levels of serum IgG and salivary SIgA were assessed by an enzyme-linked immunosorbent assay (ELISA), and caries activity was evaluated by the Keyes method. pGJA-P/VAX and pVAX1 prepared by a laboratory-scale commercial kit were used as controls. Results: The production process proved to be scalable and reproducible. Impurities including host protein, residual RNA, genomic DNA and endotoxin in the purified plasmid were all under the limits of set specifications. Intranasal vaccination with clinical-grade pGJA-P/VAX induced higher serum IgG and salivary SIgA in both mice and gnotobiotic rats. While in the experimental caries model, the enamel (E), dentinal slight (Ds), and dentinal moderate (Dm) caries lesions were reduced by 21.1%, 33.0%, and 40.9%, respectively. Conclusion: The production process under GMP was efficient in preparing clinical-grade pGJA-P/VAX with high purity and intended effectiveness, thus facilitating future clinical trials for the anti-caries DNA vaccine. PMID:19890359

  10. 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

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Parts 1, 16, 106, 110, 114, 117, 120, 123, 129, 179, and 211 RIN 0910-AG36 Current Good Manufacturing Practice and Hazard Analysis and Risk- Based Preventive Controls for Human Food; Extension of Comment Periods AGENCY: Food and Drug Administration,...

  11. 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

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Parts 1, 16, 106, 110, 114, 117, 120, 123, 129, 179, and 211 RIN 0910-AG36 Current Good Manufacturing Practice and Hazard Analysis and Risk- Based...: Food and Drug Administration, HHS. ACTION: Proposed rule; extension of comment period for...

  12. 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

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Parts 1, 16, 106, 110, 114, 117, 120, 123, 129, 179, and 211 RIN 0910-AG36 Current Good Manufacturing Practice and Hazard Analysis and Risk- Based Preventive Controls for Human Food; Extension of Comment Periods AGENCY: Food and Drug Administration,...

  13. 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.

  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.

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

    PubMed

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

    2015-02-01

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

  16. Good manufacturing practice requirements for the production of tissue vitrification and warming and recovery kits for clinical research.

    PubMed

    Laronda, Monica M; McKinnon, Kelly E; Ting, Alison Y; Le Fever, Ann V; Zelinski, Mary B; Woodruff, Teresa K

    2017-02-01

    Products that are manufactured for use in a clinical trial, with the intent of gaining US Food and Drug Administration (FDA) approval for clinical use, must be produced under an FDA approved investigational new drug (IND) application. We describe work done toward generating reliable methodology and materials for preserving ovarian cortical tissue through a vitrification kit and reviving this tissue through a warming and recovery kit. We have described the critical steps, procedures, and environments for manufacturing products with the intent of submitting an IND. The main objective was to establish an easy-to-use kit that would ensure standardized procedures for quality tissue preservation and recovery across the 117 Oncofertility Consortium sites around the globe. These kits were developed by breaking down the components and steps of a research protocol and recombining them in a way that considers component stability and use in a clinical setting. The kits were manufactured utilizing current good manufacturing practice (cGMP) requirements and environment, along with current good laboratory practices (cGLP) techniques. Components of the kit were tested for sterility and endotoxicity, and morphological endpoint release criteria were established. We worked with the intended down-stream users of these kits for development of the kit instructions. Our intention is to test these initial kits, developed and manufactured here, for submission of an IND and to begin clinical testing for preserving the ovarian tissue that may be used for future restoration of fertility and/or hormone function in women who have gonadal dysgenesis from gonadotoxic treatment regimens or disease.

  17. 78 FR 64735 - Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-29

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

  18. 21 CFR 4.4 - How can I comply with these current good manufacturing practice requirements for a co-packaged or...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... manufacturing practice requirements for a co-packaged or single-entity combination product? 4.4 Section 4.4 Food... comply with these current good manufacturing practice requirements for a co-packaged or single-entity combination product? (a) Under this subpart, for single entity or co-packaged combination products,...

  19. 21 CFR 4.4 - How can I comply with these current good manufacturing practice requirements for a co-packaged or...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... manufacturing practice requirements for a co-packaged or single-entity combination product? 4.4 Section 4.4 Food... comply with these current good manufacturing practice requirements for a co-packaged or single-entity combination product? (a) Under this subpart, for single entity or co-packaged combination products,...

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

    PubMed

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

    2016-03-01

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

  1. 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

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

    2002-03-01

    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

  2. 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

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

    PubMed

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

    2015-06-14

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

  4. Good manufacturing practices production of natural killer cells for immunotherapy: a six-year single-institution experience.

    PubMed

    McKenna, David H; Sumstad, Darin; Bostrom, Nancy; Kadidlo, Diane M; Fautsch, Susan; McNearney, Sarah; Dewaard, Rose; McGlave, Philip B; Weisdorf, Daniel J; Wagner, John E; McCullough, Jeffrey; Miller, Jeffrey S

    2007-03-01

    Natural killer (NK) cells, a subset of lymphocytes and part of the innate immune system, play a crucial role in defense against cancer and viral infection. Herein is a report on the experience of clinical-scale, good manufacturing practices (GMPs) production of NK cells to treat advanced cancer. Two types of NK cell enrichments were performed on nonmobilized peripheral blood mononuclear cell apheresis collections with a cell selection system (CliniMACS, Miltenyi): CD3 cell depletion to enrich for NK cells and CD3 cell depletion followed by CD56 cell selection to obtain a more pure NK cell product. After overnight incubation with interleukin-2 (IL-2), cells were washed, resuspended in 5 percent human serum albumin, and then released for infusion. A total of 70 NK cell therapy products have been manufactured for patient infusion since 2000. For the CD3 cell-depleted NK cell products, the mean purity, recovery, and viability were 38, 79, and 86 percent, respectively. For the CD3 cell-depleted/CD56 cell-enriched NK cell products, the mean purity, recovery, and viability were 90, 19, and 85 percent, respectively. Gram stain, sterility, and endotoxin testing were all within acceptable limits for established lot release. Compared to the resting processed cells, IL-2 activation significantly increased the function of cells in cytotoxicity assays. Clinical-scale production of NK cells is efficient and can be performed under GMPs. The purified NK cell product results in high NK cell purity with minimal contamination by T cells, monocytes, and B cells, but it requires more time for processing and results in a lower NK cell recovery when compared to NK cell enrichment with CD3 cell depletion alone. Additional laboratory studies and results from clinical trials will identify the best source and type of NK cell product.

  5. A kit formulated under good manufacturing practices for labeling human epidermal growth factor with 111In for radiotherapeutic applications.

    PubMed

    Reilly, Raymond M; Scollard, Deborah A; Wang, Judy; Mondal, Hridya; Chen, Paul; Henderson, Lee A; Bowen, Barry M; Vallis, Katherine A

    2004-04-01

    Our goal was to design and manufacture a kit under good manufacturing practices (GMP) for the preparation of (111)In-DTPA-hEGF Injection, a novel targeted radiotherapeutic agent for advanced epidermal growth factor receptor (EGFR)-positive breast cancer. Human EGF (hEGF) was derivatized with diethylenetriaminepentaacetic acid (DTPA) and then purified by size-exclusion chromatography and ultrafiltration. Kits were prepared by dispensing 0.25 mg (1 mL) of DTPA-hEGF in 1 mol/L sodium acetate buffer [pH 6.0] into single-dose glass vials. Raw materials were pharmacopoieal or reagent grade according to the American Chemical Society and were tested for identity and purity. Kits were tested for protein concentration, purity and homogeneity (sodium dodecyl sulfate polyacrylamide gel electrophoresis and size-exclusion high-performance liquid chromatography), pH, clarity and color, volume, DTPA substitution, labeling efficiency, receptor binding to MDA-MB-468 human breast cancer cells, and sterility and apyrogenicity. (111)In-DTPA-hEGF Injection was tested for pH, radionuclidic and radiochemical purity, clarity and color, and sterility and apyrogenicity. Four lots of kits and 8 lots of (111)In-DTPA-hEGF Injection passed all quality specifications. The labeling efficiency was 94%-99% with 115-773 MBq (111)In chloride added to a single kit. (111)In-DTPA-hEGF exhibited preserved receptor binding against MDA-MB-468 cells (affinity constant [K(a)], 0.9-1.1 x 10(7) L/mol; maximum number of binding sites per cell [B(max)], 1.1-2.2 x 10(6) sites per cell). In addition, labeling of aliquots of the kit suggested that a single vial could be labeled with up to 3,083 MBq (111)In while maintaining a radiochemical purity of >90%. Kits were stable for >90 d and (111)In-DTPA-hEGF Injection was stable for >24 h stored at 4 degrees C. The kit formulation is suitable for preparing (111)In-DTPA-hEGF Injection for a phase I clinical trial in patients with advanced EGFR-positive breast cancer

  6. 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

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

    PubMed

    Lai, Huafang; Chen, Qiang

    2012-03-01

    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 be established for processing virus-like particles (VLPs) 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.

  8. 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.

  9. 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

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

    PubMed

    Pham, Phuc Van; Vu, Ngoc Bich; Pham, Vuong Minh; Truong, Nhung Hai; Pham, Truc Le-Buu; Dang, Loan Thi-Tung; Nguyen, Tam Thanh; Bui, Anh Nguyen-Tu; Phan, Ngoc Kim

    2014-02-24

    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. 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. 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. This technique provides a method to obtain UCB-MSCs compliant with good manufacturing practices for clinical application.

  11. Quantification of the islet product: presentation of a standardized current good manufacturing practices compliant system with minimal variability.

    PubMed

    Friberg, Andrew S; Brandhorst, Heide; Buchwald, Peter; Goto, Masafumi; Ricordi, Camillo; Brandhorst, Daniel; Korsgren, Olle

    2011-03-27

    Accurate islet quantification has proven difficult to standardize in a good manufacturing practices (GMP) approved manner. The influence of assessment variables from both manual and computer-assisted digital image analysis (DIA) methods were compared using calibrated, standardized microspheres or islets alone. Additionally, a mixture of microspheres and exocrine tissue was used to evaluate the variability of both the current, internationally recognized, manual method and a novel GMP-friendly purity- and volume-based method (PV) evaluated by DIA in a semiclosed, culture bag system. Computer-assisted DIA recorded known microsphere size distribution and quantities accurately. By using DIA to evaluate islets, the interindividual manually evaluated percent coefficients of variation (CV%; n=14) were reduced by almost half for both islet equivalents (IEs; 31% vs. 17%, P=0.002) and purity (20% vs. 13%, P=0.033). The microsphere pool mixed with exocrine tissue did not differ from expected IE with either method. However, manual IE resulted in a total CV% of 44.3% and a range spanning 258 k IE, whereas PV resulted in CV% of 10.7% and range of 60 k IE. Purity CV% for each method were similar approximating 10.5% and differed from expected by +7% for the manual method and +3% for PV. The variability of standard counting methods for islet samples and clinical quantities of microspheres mixed with exocrine tissue were reduced with DIA. They were reduced even further by use of a semiclosed bag system compared with standard manual counting, thereby facilitating the standardization of islet evaluation according to GMP standards.

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

    PubMed

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

    2013-11-01

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

  13. A Good Manufacturing Practice-grade standard protocol for exclusively human mesenchymal stromal cell-derived extracellular vesicles.

    PubMed

    Pachler, Karin; Lener, Thomas; Streif, Doris; Dunai, Zsuzsanna A; Desgeorges, Alexandre; Feichtner, Martina; Öller, Michaela; Schallmoser, Katharina; Rohde, Eva; Gimona, Mario

    2017-04-01

    Extracellular vesicles (EVs) released by mesenchymal stromal cells (MSCs) may contribute to biological processes such as tissue regeneration, immunomodulation and neuroprotection. Evaluation of their therapeutic potential and application in future clinical trials demands thorough characterization of EV content and production under defined medium conditions, devoid of xenogenic substances and serum-derived vesicles. Addressing the apparent need for such a growth medium, we have developed a medium formulation based on pooled human platelet lysate (pHPL), free from animal-derived xenogenic additives and depleted of EVs. Depletion of EVs from complete growth medium was achieved by centrifugation at 120 000 g for 3 h, which reduced RNA-containing pHPL EVs to below the detection limit. Bone marrow (BM)-derived MSCs propagated in this medium retained the characteristic surface marker expression, cell morphology, viability and in vitro osteogenic and adipogenic differentiation potential. The proliferation rate was not significantly affected after 48 h but was decreased by 13% after 96 h. EVs collected from BM-MSCs cultured in EV-depleted medium revealed a similar RNA pattern as EVs generated in standard pHPL EV-containing medium but displayed a more clearly defined pattern of proteins characteristic for EVs. Reduction of pHPL content from 10% to 2% or serum-/pHPL-free conditions strongly altered MSC characteristics and RNA content of released EV. The 10% pHPL-based EV-depleted medium is appropriate for purification of exclusively human MSC-derived EVs. With this Good Manufacturing Practice-grade protocol, characterization and establishment of protein and RNA profiles from MSC-derived EVs can now be achieved to identify active components in therapeutic EVs for future clinical application. Copyright © 2017 International Society for Cellular Therapy. Published by Elsevier Inc. All rights reserved.

  14. Developing Good Practices

    ERIC Educational Resources Information Center

    Fox, Sharon E.

    1972-01-01

    Discusses some good oral reading concepts that teachers should consider when developing new classroom practices, including: round robin reading, silent reading before oral reading, shared reading, etc. (NL)

  15. [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.

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

    PubMed

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

    2017-05-01

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

  17. 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

  18. 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.

  19. Promoting good practice.

    PubMed

    2004-04-01

    Meanwhile, the Scottish Executive's Centre for Change and Innovation, which was set up to identify and promote good practice and increase the pace of change to benefit patients, has an informative website at www.cci.scot.nhs.uk which provides details of a range of innovative projects currently underway. The site has main sections focusing on, among other things, national and local programmes, best practice examples, feedback, advice on managing teams, and developing organisations. It also provides a link to the NHS Education for Scotland electronic library.

  20. 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

  1. 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.

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

    PubMed

    2007-06-25

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

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

    PubMed

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

    2009-09-08

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

  4. 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

  5. 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.

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

    PubMed

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

    2002-02-01

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

  7. 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

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

    PubMed

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

    2016-11-16

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

  9. 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.

  10. 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.

  11. Production and validation of a good manufacturing practice grade human fibroblast line for supporting human embryonic stem cell derivation and culture

    PubMed Central

    2012-01-01

    Introduction The development of reproducible methods for deriving human embryonic stem cell (hESC) lines in compliance with good manufacturing practice (GMP) is essential for the development of hESC-based therapies. Although significant progress has been made toward the development of chemically defined conditions for the maintenance and differentiation of hESCs, efficient derivation of new hESCs requires the use of fibroblast feeder cells. However, GMP-grade feeder cell lines validated for hESC derivation are not readily available. Methods We derived a fibroblast cell line (NclFed1A) from human foreskin in compliance with GMP standards. Consent was obtained to use the cells for the production of hESCs and to generate induced pluripotent stem cells (iPSCs). We compared the line with a variety of other cell lines for its ability to support derivation and self-renewal of hESCs. Results NclFed1A supports efficient rates (33%) of hESC colony formation after explantation of the inner cell mass (ICM) of human blastocysts. This compared favorably with two mouse embryonic fibroblast (MEF) cell lines. NclFed1A also compared favorably with commercially available foreskin fibroblasts and MEFs in promoting proliferation and pluripotency of a number of existing and widely used hESCs. The ability of NclFed1A to maintain self-renewal remained undiminished for up to 28 population doublings from the master cell bank. Conclusions The human fibroblast line Ncl1Fed1A, produced in compliance with GMP standards and qualified for derivation and maintenance of hESCs, is a useful resource for the advancement of progress toward hESC-based therapies in regenerative medicine. PMID:22472092

  12. Good Manufacturing Practice Production of Self-Complementary Serotype 8 Adeno-Associated Viral Vector for a Hemophilia B Clinical Trial

    PubMed Central

    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.

    2011-01-01

    Abstract 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 × 1015 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. PMID:21410419

  13. Good Practices for Transforming Education

    ERIC Educational Resources Information Center

    Benavente, Ana; Panchaud, Christine

    2008-01-01

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

  14. An innovative method to generate a Good Manufacturing Practice-ready regulatory T-cell product from non-mobilized leukapheresis donors.

    PubMed

    Zhang, Wei; Smythe, Jon; Frith, Emma; Belfield, Helen; Clarke, Sophie; Watt, Suzanne M; Danby, Robert; Benjamin, Sylvia; Peniket, Andy; Roberts, David J

    2015-09-01

    There is real and sustained interest in preparing T-regulatory cells from leukapheresis collections for cellular therapy through the use of simple, effective and reliable methods conforming to Good Manufacturing Practice (GMP). We describe a GMP-ready isolation procedure for CD25(+) products with the use of a sterile docking device, pigtail sampling, a laminar flow hood and the CliniMACS system that uses leukapheresis collections made by two apheresis machines. We used CD8/CD19 depletion followed by CD25-positive selection. The median number of CD4(+) cells recovered was 72.5 ± 32.6 × 10(6), of which 60.5% ± 17.8% were CD25(+)FOXP3(+) cells. Suppression of autologous CD25(-) cell proliferation by the cryopreserved CD25(+) products was 51.3% ± 4.4%, 49.0% ± 3.7% and 39.0% ± 3.6% at CD25(+):CD25(-) ratios of 1:1, 1:2 and 1:4 (n = 6), respectively, comparable to suppression by fresh CD25(+) products (53% ± 6.2%, 51% ± 3.3% and 39% ± 7.1%). We found Leukapheresis collections by Cobe Spectra contained more lymphocytes and platelets than collections by Spectra Optia apheresis machine (median, 9.2 × 10(9) versus 6.7 × 10(9); P = 0.04) and platelets (median, 610 × 10(9) versus 170 × 10(9); P = 0.04). The frequency of CD4(+)CD25(+)FOXP3(+) was significantly higher in the leukapheresis (4.85%; 95% confidence interval, 1.95% to 5.38%) than in peripheral blood (3.9%; 95% confidence interval, 2.63% to 6.45%) (P = 0.02). The CD8- and CD19-negative depletion step was associated with significant loss of total CD4(+) T cells (P = 0.001). Results suggest that functional CD25(+) products can be isolated with a GMP-ready method, and good recovery can be obtained with the use of an optimized cryopreservation protocol. These data and methods show the potential, possibilities and future work needed to isolate target cell populations in a reproducible, time-efficient and cost-efficient manner for clinical applications. Copyright © 2015. Published by Elsevier Inc.

  15. 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.

  16. 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.

  17. Observations on medical device design, Part II: Good practice.

    PubMed

    Alexander, K; Clarkson, J; Bishop, D

    1999-10-01

    Current guidance on design is inadequate. This second article in a two-part series presents a framework for good design practice that attempts to improve designers' awareness of manufacturing and validation issues. Seven design tactics, derived from observations of current industry practice and design literature, seek to encourage good practice and achieve safer, more profitable devices.

  18. 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…

  19. 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.

  20. Good cell culture practices &in vitro toxicology.

    PubMed

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

    2017-04-25

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

  1. Good practice with endometrial ablation.

    PubMed

    Garry, R

    1995-07-01

    To provide clear guidelines for the safe and effective performance of endometrial ablation. Representatives of American, Australian, British, and Canadian hysteroscopists were brought together to produce a consensus document of good practice in endometrial ablation. The guidelines were produced after researching the literature, combining the extensive experience of the group, and debating the relevant issues. Endometrial ablation is a new procedure. Correct patient selection is essential in producing good results. Patients must be counseled carefully about the advantages, disadvantages, and potential complications of this approach to the management of menstrual disorders. The main indication for endometrial ablation is heavy menstrual loss in the absence of organic disease. Excessive uterine size, the presence of active pelvic infection, and evidence of malignant and premalignant endometrium are absolute contraindications. Ablation can be produced by electrosurgical resection, rollerball or rollerbarrel ablation and Nd-YAG laser ablation. Severe complications can occur, and techniques should be adopted to avoid uterine perforation, hemorrhage, and excessive fluid absorption. In skilled hands, endometrial ablation can be a safe and effective treatment for menorrhagia.

  2. 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.

  3. Current good manufacturing practices for transfusion medicine.

    PubMed

    Sazama, K

    1996-10-01

    Transfusion medicine is most tightly controlled in the US by CGMPs that are written as regulations, guidances, and quality management documents. Because the US regulatory scheme requires that each unit of human blood donated for transfusion (and other purposes) be documented from the moment of donor registration until the last component of that donation is finally disposed of, there is precious little that remains solely within the discretion of the treating physician who orders transfusions for her or his patients. An additional complication for transfusion medicine specialists is that the search for the requirements must extend to all possible areas of information, including the possibly unexpected source within the private sector.

  4. Good nutritional practice from producer to consumer.

    PubMed

    Raspor, P; Jevsnik, M

    2008-03-01

    Today we manage food safety through good practices at different levels of food production, distribution, and consumption. The paper analyses current good practices, parameters involved in the food safety circle along the food supply chain, and consumer dilemmas. As a result of the current situation the new approach called "Good Nutritional Practice" (GNP) is proposed to balance the food safety systems. It is shown how important it is to integrate actual the food safety solutions within GNP, which includes consumers, and is based on a model that covers subsystems from other relevant good practices (nine good practices along the food supply chain). It has been shown that present maintenance of food safety in the food supply chain can be easily broken down, because of the different kinds of barriers or a simple misunderstanding among stakeholders including consumers.

  5. Development and validation of a multiplex quantitative polymerase chain reaction assay for the detection of Mollicutes impurities in human cells, cultured under good manufacturing practice conditions, and following European Pharmacopoeia requirements and the International Conference on Harmonization guidelines.

    PubMed

    Vanni, Irene; Ugolotti, Elisabetta; Raso, Alessandro; Di Marco, Eddi; Melioli, Giovanni; Biassoni, Roberto

    2012-07-01

    The clinical applications of in vitro manipulated cultured cells and their precursors are often made use of in therapeutic trials. However, tissue cultures can be easily contaminated by the ubiquitous Mollicutes micro-organisms, which can cause various and severe alterations in cellular function. Thus methods able to detect and trace Mollicutes impurities contaminating cell cultures are required before starting any attempt to grow cells under good manufacturing practice (GMP) conditions. We developed a multiplex quantitative polymerase chain reaction (qPCR) assay specific for the 16S-23S rRNA intergenic spacer regions, for the Tuf and P1 cytoadhesin genes, able to detect contaminant Mollicutes species in a single tube reaction. The system was validated by analyzing different cell lines and the positive samples were confirmed by 16S and P1 cytoadhesin gene dideoxy sequencing. Our multiplex qPCR detection system was able to reach a sensitivity, specificity and robustness comparable with the culture and the indicator cell culture method, as required by the European Pharmacopoeia guidelines. We have developed a multiplex qPCR method, validated following International Conference on Harmonization (ICH) guidelines, as a qualitative limit test for impurities, assessing the validation characteristics of limit of detection and specificity. It also follows the European Pharmacopoeia guidelines and Food and Drug Administration (FDA) requirements.

  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. Good documentation practice in clinical research.

    PubMed

    Bargaje, Chitra

    2011-04-01

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

  8. Good documentation practice in clinical research

    PubMed Central

    Bargaje, Chitra

    2011-01-01

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

  9. 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…

  10. 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…

  11. 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... tobacco industry and its manufacturing operations. DATES: Submit electronic or written comments on...

  12. Good Law, Good Practice, Good Sense: Using Legal Guidelines for Drafting Educational Policies.

    ERIC Educational Resources Information Center

    Bogotch, Ira E.

    1988-01-01

    Suggests how to use legal guidelines for drafting educational policies. Analyzes the political context in which present policymaking and governance initiatives exist. Two assumptions frame this article. First, good law makes for good administrative practice. Second, administrator policymaking is more important than the content of the policy…

  13. Principles of Good Practice in Continuing Education.

    ERIC Educational Resources Information Center

    Council on the Continuing Education Unit, Silver Spring, MD.

    Intended to serve as a standard reference document for the field of continuing education and training, this set of criteria for good practice is for general use by all sponsors, providers, and users of continuing education within any setting, for any clientele, and for individual learners. Following an introduction, suggestions are made for use of…

  14. 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…

  15. 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…

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

    PubMed

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

    2004-06-01

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

  17. Gluing Practice at Aircraft Manufacturing Plants

    NASA Technical Reports Server (NTRS)

    Truax, T R

    1928-01-01

    This report records observations and recommendations resulting from an inspection trip to representative aircraft manufacturing establishments and repair stations. This inspection was made for the Navy Department and was specifically in reference to gluing practice at the various places visited. The period of the visits was between November 23, 1926 and February 16, 1927.

  18. 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.

  19. 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.

  20. [Guidelines for good practice of sports activities].

    PubMed

    Scheen, A J; Crielaard, J M

    2001-05-01

    The present closing article summarizes some guidelines for the good practice of physical activities in order to develop and maintain cardiorespiratory and muscular fitness, and flexibility. Advice is given regarding the recommended quantity and quality of exercise in term of intensity, duration and frequency of training with the aim to optimize the risk/benefit ratio for health, in both aerobic endurance and resistance exercises. The crucial role of an appropriate warm-up and cool-down period, which would include flexibility exercises, is also emphasized. Finally, some practical examples illustrate this vademecum of physical activities.

  1. 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.

  2. 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.

  3. Good laboratory practice and laboratory accreditation.

    PubMed

    Lawrence, J; McQuaker, N

    1993-12-01

    Principles of good laboratory practice (GLP) and laboratory accreditation programs, particularly as they pertain to the environmental sector, are reviewed. The multitude of programs is proving costly for many laboratories and there is mounting pressure to develop reciprocity agreements between programs and to consolidate nationally and internationally. Inclusion of GLP and laboratory accreditation requirements in government regulations is resulting in a significantly increased number of laboratories participating in these programs.

  4. Good enough practices in scientific computing.

    PubMed

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

    2017-06-01

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

  5. 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…

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

    ERIC Educational Resources Information Center

    Jorgensen, Haley

    2006-01-01

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

  7. Improving nutritional care: innovation and good practice.

    PubMed

    Chapman, Carol; Barker, Mary; Lawrence, Wendy

    2015-04-01

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

  8. 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.

  9. 40 CFR 86.1851-01 - Application of good engineering judgment to manufacturers' decisions.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

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

  10. 40 CFR 86.1851-01 - Application of good engineering judgment to manufacturers' decisions.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

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

  11. 40 CFR 86.1851-01 - Application of good engineering judgment to manufacturers' decisions.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

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

  12. 40 CFR 86.1851-01 - Application of good engineering judgment to manufacturers' decisions.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

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

  13. 40 CFR 86.1851-01 - Application of good engineering judgment to manufacturers' decisions.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

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

  14. Risk Management: A Guide to Good Practice for Higher Education Institutions. Good Practice.

    ERIC Educational Resources Information Center

    Higher Education Funding Council for England, Bristol.

    This document draws on good practice in the higher education sector and elsewhere to provide practical guidance to higher education institutions in England on risk management. The guide is aimed at those involved in planning and implementing a risk management program. It contains case studies designed to be used as training materials, a sample…

  15. Good practices for quantitative bias analysis.

    PubMed

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

    2014-12-01

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

  16. Intravenous therapy: a guide to good practice.

    PubMed

    Scales, Katie

    This article provides an overview of the principles of good practice that underpin intravenous (IV) therapy. The indications for choosing the IV route and selecting an appropriate vascular access device (VAD) are explained. Common insertion sites for VAD placement and the care and management of VADs are reviewed. Infection control aspects of IV therapy are be highlighted, including the management of IV equipment and the importance of the nurse's role in the prevention of infection associated with IV therapy. Common complications of IV therapy are explained and strategies suggested for their prevention. The article addresses the issues associated with general IV therapy, it does not address specialist subjects such as parenteral nutrition, chemotherapy or blood transfusion.

  17. Guidelines on Good Clinical Laboratory Practice

    PubMed Central

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

    2008-01-01

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

  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. [Good laboratory practice in occupational hygiene].

    PubMed

    Stetkiewicz, Jan

    2004-01-01

    Good laboratory practice (GLP) is the system that ensures quality assessment, defines the organization rules of institutions performing non-clinical studies in the area of human and environmental safety in general, and of chemicals and chemical preparations in particular as well as sets the conditions of planning, performing and monitoring of studies, the outcome of which is recorded, stored and reported. Occupational hygiene is an area of activities that involves anticipation, assessment and surveillance of health hazards in the work environment aimed at protecting health of workers and the population at large (IOHA). Assessment and control of harmful agents, which occur in the work environment, technological processes or methods of work should be carried out by research units (laboratories) with well documented competencies in the environment and/or biological monitoring, and those granted accreditation according to EN/ISO 17025. Anticipated risks should be based on analyses of physical, chemical and toxic properties of harmful agents, performed in line with the rules of good laboratory practice. Accredited laboratories and the quality of their tests are monitored by governmental agencies. The application of the GLP system provides: the opportunity to investigate analytical procedures and data (the documentation concerning each stage of a given analysis should ensure a complete reconstruction of the whole analytical process); the confirmed reliability of the results; the recognition of the results in European Union member states and by the Organization for Economic Cooperation and Development (OECD); the opportunity to avoid repetition of analyses and studies; a better care of the human health and environment.

  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.

  1. 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.

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

    Code of Federal Regulations, 2013 CFR

    2013-01-01

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

  3. 2 CFR 176.110 - Evaluating proposals of foreign iron, steel, and/or manufactured goods.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

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

  4. 2 CFR 176.110 - Evaluating proposals of foreign iron, steel, and/or manufactured goods.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

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

  5. 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…

  6. Seven Principles for Good Practice in Legal Education: Principle 2: Good Practice Encourages Cooperation among Students.

    ERIC Educational Resources Information Center

    Dominguez, David

    1999-01-01

    One of a series of articles on principles of good practice in legal education, this article focuses on the importance of encouraging cooperation among students. Considers the value of the learning community and the relationship of cooperative learning and academic excellence. Includes examples of cooperative learning in a variety of law school…

  7. 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…

  8. Scientific dishonesty and good scientific practice.

    PubMed

    Andersen, D; Axelsen, N H; Riis, P

    1993-04-01

    Scientific dishonesty has been the subject of much public interest in recent years. Although the problem has had a low profile in Denmark, there is no reason to believe that it is non-existent. Several preconditions known to be important prevail here as well as in other countries, such as pressure to publish and severe competition for research grants and senior academic positions. The Danish Medical Research Council (DMRC) decided to respond to this problem by preparing a report on scientific dishonesty with suggestions to the research institutions on rules for good scientific practice and procedures for investigation of suspected dishonesty. To this end, an investigatory system was suggested. The system should consist of two regional committees and one national committee. They should be headed by high court judges and experienced health sciences researchers as members. The committees will investigate cases reported to them and conclude on whether dishonesty has been established and on whether the scientific work should be retracted. Sanctions shall remain the task of the institutions. Preventive measures comprise open access to and a long storage period for scientific data.

  9. 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. © 2014 The Authors. British Journal of Haematology published by John Wiley & Sons Ltd.

  10. 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 Central

    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

    2014-01-01

    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

  11. 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

  12. Safety climate practice in Korean manufacturing industry.

    PubMed

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

    2008-11-15

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

  13. 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...

  14. 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. Copyright © 2016 John Wiley & Sons, Inc.

  15. 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...

  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. Twenty-Two Good Educational Practices.

    ERIC Educational Resources Information Center

    Mark, Jorie Lester

    1989-01-01

    Twenty-two educational practices are drawn from nine settings: K-12, vocational and continuing education, proprietary schools, military training, corporate training, union-sponsored programs, second-chance training, job training, and adult education. They are categorized as process-type practices, techniques, and physical teaching props. (SK)

  18. Workplace practices for engineered nanomaterial manufacturers.

    PubMed

    Woskie, Susan

    2010-01-01

    The growth in nanotechnology has prompted a focus on the development of occupational health and safety recommendations for those working with engineered nanomaterials (ENM) at both the laboratory and the manufacturing levels. Although the nascent field of nanotoxicology has shown that some nanoparticles may present a health hazard to humans, risk assessments for all types of ENM are not possible. Hence, a precautionary approach to handling of these materials is recommended along with the development of a comprehensive health and safety program for the workplace. The traditional hierarchy of exposure controls emphasizes reducing the hazard as close to the source as possible by using elimination or substitution. Alternative control methods include engineering controls, administrative or work practice controls, and finally personal protective equipment, in order of decreasing priority. There is now ample evidence that some degree of exposure control can be achieved with each of these control methods, so that a comprehensive program will incorporate each, depending on the circumstances of the engineered nanomaterial use. © 2010 John Wiley & Sons, Inc.

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

    ERIC Educational Resources Information Center

    Huws, Ursula; And Others

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

  20. 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…

  1. 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…

  2. Getting to Scale with Good Educational Practice.

    ERIC Educational Resources Information Center

    Elmore, Richard F.

    1996-01-01

    School organization and incentive structures help thwart large-scale adoption of innovative educational practices. Evidence from the progressive movement and past curriculum reform efforts suggest that wide-scale reforms are ineffective under current conditions. Change requires external normative structures, organizations that focus intrinsic…

  3. 40 CFR 1068.5 - How must manufacturers apply good engineering judgment?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

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

  4. 40 CFR 1068.5 - How must manufacturers apply good engineering judgment?

    Code of Federal Regulations, 2014 CFR

    2014-07-01

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

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

    Code of Federal Regulations, 2011 CFR

    2011-07-01

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

  6. 40 CFR 59.603 - How must manufacturers apply good engineering judgment?

    Code of Federal Regulations, 2012 CFR

    2012-07-01

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

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

    Code of Federal Regulations, 2013 CFR

    2013-07-01

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

  8. 40 CFR 59.603 - How must manufacturers apply good engineering judgment?

    Code of Federal Regulations, 2014 CFR

    2014-07-01

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

  9. 40 CFR 1068.5 - How must manufacturers apply good engineering judgment?

    Code of Federal Regulations, 2012 CFR

    2012-07-01

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

  10. 40 CFR 1068.5 - How must manufacturers apply good engineering judgment?

    Code of Federal Regulations, 2013 CFR

    2013-07-01

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

  11. 40 CFR 59.603 - How must manufacturers apply good engineering judgment?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

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

  12. 40 CFR 1068.5 - How must manufacturers apply good engineering judgment?

    Code of Federal Regulations, 2011 CFR

    2011-07-01

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

  13. 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

    ..., Steel, and Manufactured Goods (covered under International Agreements)-Section 1605 of the American... Award term—Required Use of American Iron, Steel, and Manufactured Goods (covered under International... involves iron, steel, and/or manufactured goods materials covered under international agreements,...

  14. 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)…

  15. [Good practice of image-guided radiotherapy].

    PubMed

    de Crevoisier, R; Créhange, G; Castelli, J; Lafond, C; Delpon, G

    2015-10-01

    Image-guided radiotherapy (IGRT) aims to take into account the anatomical variations occurring during the course of radiotherapy, by direct or indirect visualization of the target volume followed by a corrective action. The movements of the target, or at least the set-up errors are corrected by moving the treatment table, corresponding to the simplest and most validated IGRT modality in a standard practice. The deformations of the target volume and organs at risk are however much more common, and unfortunately much more complicated to consider, requiring multiple planning before or during the treatment, corresponding to the adaptive radiotherapy strategies. The planning target volume must be carefully chosen according to these anatomic variations. This article reviews the modalities of IGRT, standard or under evaluation, according to the different tumour sites. Copyright © 2015. Published by Elsevier SAS.

  16. Biological nurse specialist: goodwill to good practice.

    PubMed

    Palmer, Deborah; El Miedany, Yasser

    The extensive use of biological agents in recent years for the treatment of rheumatological diseases has required a steep learning curve for the specialist nurses who manage and work in this specialty. Safe prescribing of biological therapies requires good infrastructure and specialist nursing personnel. With additional training, the specialist nurse may take responsibility for a number of tasks in the patient pathway including screening, treatment administration, patient education, prescription coordination for home drug delivery, patient support, monitoring and data collection. Biological treatment is becoming more widely used in several specialities, in particular gastroenterology, dermatology and ophthalmology. Since 2002, rheumatology specialist nurses have taken the lead in assessment and providing biologic therapy, not only for patients suffering from rheumatic diseases but also for those with immune-mediated inflammatory disorders. The unique nature and variable safety profiles of these agents led to the development of immune-mediated inflammatory disease infusion (IMID) centres and highlighted the importance of having biological specialist nurses. This article will discuss the evolution of the IMID/biologic specialist nurse role and how IMID services started with goodwill from the rheumatology nurse specialists to develop into a main component of the holistic approach to care.

  17. [Good laboratory practice of equilibrium solubility measurement].

    PubMed

    Baka, Edit

    2011-01-01

    The biggest part of my PhD work was the standardization of the classical saturation shake-flask solubility method. During the experiments we examined systematically which parameters have significant influence on the solubility value and how large experimental error (standard deviation) is caused by them in the solubility method. Hydrochlorothiazide was used as model compound. Modification in temperature, sedimentation time, composition of aqueous buffer and the technique of separation of solid and liquid phases were found to influence the equilibrium solubility results strongly. However, variations in the amount of solid excess and stirring time were found to have less influence. Based on this standardization study, we developed a new shorter (36 hours) protocol for measurements of equilibrium solubility of drug molecules. The new protocol was validated with the aid of 6 structurally different compounds. The equilibrium solubility was measured by both (standard and new) protocols. The results were in good agreement, so the shorter protocol can be applied to measure the equilibrium solubility of drug compounds.

  18. [Blood components and good practices in transfusion].

    PubMed

    Andreu, Georges

    2015-02-01

    Each year, more than three millions of blood components are transfused to more than five hundred thousand patients in France. The optimal use of blood components requires that physicians prescribing blood components master the clinical indications of red blood cells concentrates, platelet concentrates and fresh frozen plasma. In addition, physicians in charge of blood component prescription should provide adequate pre- and post-transfusion information to their patients. Compliance of blood components administration in patients with safety guidelines contributes as well to their optimal use. In addition, for each blood component transfused, a proper evaluation of its safety and its efficacy should be done. Finally, a regular evaluation of transfusion practice in hospital services were blood components are used, through audits made in cooperation with their blood component provider, either blood transfusion centre or the hospital blood bank, enables to appreciate the level of compliance with safety and clinical guidelines, and more globally how the transfusion process is mastered. Copyright © 2014 Elsevier Masson SAS. All rights reserved.

  19. 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…

  20. 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…

  1. 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…

  2. 75 FR 80011 - Good Laboratory Practice for Nonclinical Laboratory Studies

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-21

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

  3. 2 CFR 176.170 - Notice of Required Use of American Iron, Steel, and Manufactured Goods (covered under...

    Code of Federal Regulations, 2010 CFR

    2010-01-01

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

  4. Manufacturing Exploration. Practical Arts. Instructor's Manual. Competency-Based Education.

    ERIC Educational Resources Information Center

    Keeton, Martha; And Others

    This manual provides curriculum materials for implementing a career exploration class in manufacturing occupations within a Practical Arts Education program for middle/junior high school students. Introductory materials include the program master sequence, a list of manufacturing occupations, an overview of the competency-based instructional…

  5. 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.

  6. 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 with...

  7. 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…

  8. 78 FR 76836 - Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-19

    ... Collection; Comment Request; Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or... on the information collection provisions of FDA's regulations regarding current good manufacturing... appropriate, and other forms of information technology. Current Good Manufacturing Practice in...

  9. Top 10 metrics for life science software good practices

    PubMed Central

    2016-01-01

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

  10. 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.

  11. Good Security Practices for Electronic Commerce, Including Electronic Data Interchange

    DTIC Science & Technology

    1993-12-01

    FROM - TO) xx-xx-2002 to xx-xx-2002 4. TITLE AND SUBTITLE Good Security Practices for Electronic Commerce , Including Electronic Data Interchange...Report 12/1/1993 4. TITLE AND SUBTITLE Good Security Practices for Electronic Commerce , Including Electronic Data Interchange 5. FUNDING NUMBERS 6...Maximum 200 Words) Electronic commerce (EC) is the use of documents in electronic form, rather than paper, for carrying out functions of business or

  12. Guide to good practices for operations organization and administration

    SciTech Connect

    Not Available

    1992-12-01

    The purpose of this Guide to Good Practices is to provide Department of Energy (DOE) contractors with information that can be used to validate and/or modify existing programs relative to Conduct of Operations. This Guide to Good Practices is part of a series of guides designed to enhance the guidelines set forth in DOE Order 5480.19, Conduct of Operations Requirements for DOE Facilities.''

  13. Guide to good practices for operations organization and administration

    SciTech Connect

    Not Available

    1992-12-01

    The purpose of this Guide to Good Practices is to provide Department of Energy (DOE) contractors with information that can be used to validate and/or modify existing programs relative to Conduct of Operations. This Guide to Good Practices is part of a series of guides designed to enhance the guidelines set forth in DOE Order 5480.19, ``Conduct of Operations Requirements for DOE Facilities.``

  14. 47 CFR 73.508 - Standards of good engineering practice.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... RADIO BROADCAST SERVICES Noncommercial Educational FM Broadcast Stations § 73.508 Standards of good... American National Standards Institute. These stations must be operated, tuned, and adjusted so that... 47 Telecommunication 4 2014-10-01 2014-10-01 false Standards of good engineering practice....

  15. Good Schools for Middle Grade Youngsters: Characteristics, Practices, and Recommendations.

    ERIC Educational Resources Information Center

    Morrison, William

    Operating on the assumption that good middle schools differ significantly from other schools and that the differences should be identifiable by a disinterested observer, the author of this document visited 39 schools and attended 3 conferences to learn at first hand the characteristics of good middle schools and to identify the practices that made…

  16. 47 CFR 73.508 - Standards of good engineering practice.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

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

  17. 47 CFR 73.508 - Standards of good engineering practice.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

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

  18. Evaluation Instruments and Good Practices in Online Education

    ERIC Educational Resources Information Center

    Baldwin, Sally J.; Trespalacios, Jesús

    2017-01-01

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

  19. 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....

  20. 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...

  1. [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.

  2. 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.

  3. 2 CFR 176.170 - Notice of Required Use of American Iron, Steel, and Manufactured Goods (covered under...

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 2 Grants and Agreements 1 2013-01-01 2013-01-01 false Notice of Required Use of American Iron... Required Use of American Iron, Steel, and Manufactured Goods (covered under International Agreements... repair of a public building or public work, and involve iron, steel, and/or manufactured goods covered...

  4. 2 CFR 176.170 - Notice of Required Use of American Iron, Steel, and Manufactured Goods (covered under...

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 2 Grants and Agreements 1 2012-01-01 2012-01-01 false Notice of Required Use of American Iron... Required Use of American Iron, Steel, and Manufactured Goods (covered under International Agreements... repair of a public building or public work, and involve iron, steel, and/or manufactured goods covered...

  5. 2 CFR 176.170 - Notice of Required Use of American Iron, Steel, and Manufactured Goods (covered under...

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 2 Grants and Agreements 1 2014-01-01 2014-01-01 false Notice of Required Use of American Iron... Iron, Steel, and Manufactured Goods (covered under International Agreements)—Section 1605 of the... building or public work, and involve iron, steel, and/or manufactured goods covered under international...

  6. 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.

  7. 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.

  8. Principles of Good Practice in SoTL

    ERIC Educational Resources Information Center

    Felten, Peter

    2013-01-01

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

  9. 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…

  10. Didactic Scenarios and ICT: A Good Practice Guide

    NASA Astrophysics Data System (ADS)

    Dagdilelis, Vassilios; Papadopoulos, Ioannis

    In this paper a 'good practice guide' is presented for creating Didactic Scenarios (D.S.) with the support of ICT. This guide is based on: a) empirical data collected during longitudinal training programs addressed to secondary education teachers, b) observation of the way ICT is used in both levels of education and c) modern didactical theories.

  11. Seven Principles for Good Practice in Undergraduate Education.

    ERIC Educational Resources Information Center

    Chickering, Arthur W.; Gamson, Zelda F.

    1987-01-01

    Seven principles that can help to improve undergraduate education are identified. Based on research on college teaching and learning, good practice in undergraduate education: (1) encourages contacts between students and faculty; (2) develops reciprocity and cooperation among students; (3) uses active learning techniques; (4) gives prompt…

  12. Investment Decision Making: A Guide to Good Practice.

    ERIC Educational Resources Information Center

    Higher Education Funding Council for England, Bristol.

    This "good practice" guide is aimed at anyone in higher education in England who is involved in making decisions on investments. It focuses on the principles to be followed, rather than the techniques of appraisal. The guide outlines the steps for developing an outline business case and then refining it into a full business case for the…

  13. 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…

  14. Developing Good Practice in New Deal in Colleges.

    ERIC Educational Resources Information Center

    Ratcliffe, Michael; Atkinson, John; Burgess, Carol; Cartner, Nadine

    This document explains how further education colleges, employment services, and other providers can develop the delivery of full-time education and training (FTET) within the United Kingdom's New Deal programs for 18- to 24-year-olds. The document identifies principles of good practice related to the following aspects of New Deal FTET: (1)…

  15. 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.

  16. Principles for Good Practice in Graduate and Professional Student Engagement

    ERIC Educational Resources Information Center

    Pontius, Jason L.; Harper, Shaun R.

    2006-01-01

    Student engagement represents a critical benchmark of educational effectiveness for graduate as well as undergraduate students. This chapter presents seven principles for good practice in engaging and connecting graduate and professional students to the larger campus community and provides examples of exemplary programs.

  17. 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…

  18. Achievement of Black Caribbean Pupils: Good Practice in Lambeth Schools

    ERIC Educational Resources Information Center

    Demie, Feyisa

    2005-01-01

    The aim of this research article is to investigate how pupils from Black Caribbean backgrounds are helped to achieve high standards in British schools and to identify a number of significant common themes for success in raising the achievement. It draws evidence of good practice from 13 case study schools in the local education authority (LEA).…

  19. 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…

  20. 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…

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

    ERIC Educational Resources Information Center

    Curtis, Pinsent

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

  2. 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.…

  3. "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.

  4. 21 CFR 10.115 - Good guidance practices.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Good guidance practices. 10.115 Section 10.115 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL... guidance documents do not legally bind FDA, they represent the agency's current thinking. Therefore,...

  5. 21 CFR 10.115 - Good guidance practices.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 1 2011-04-01 2011-04-01 false Good guidance practices. 10.115 Section 10.115 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL... guidance documents do not legally bind FDA, they represent the agency's current thinking. Therefore,...

  6. 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…

  7. 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, you...

  8. 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, you...

  9. 21 CFR 10.115 - Good guidance practices.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 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, you...

  10. 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.…

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

    ERIC Educational Resources Information Center

    Forum on Education Abroad, 2011

    2011-01-01

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

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

    ERIC Educational Resources Information Center

    Hanson, Jana Marie

    2013-01-01

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

  13. 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.

  14. Guide to good practices for developing learning objectives. DOE guideline

    SciTech Connect

    Not Available

    1992-07-01

    This guide to good practices provides information and guidance on the types of, and the development of learning objectives in performance-based training system at reactor and nonreactor nuclear facilities. Contractors are encouraged to consider this guidance as a reference when developing new learning objectives or refining existing ones. Training managers, designers, developers, and instructors are the intended audiences.

  15. 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.

  16. 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.

  17. 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.

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

    NASA Astrophysics Data System (ADS)

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

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

  19. Health physics manual of good practices for accelerator facilities

    SciTech Connect

    Casey, W.R.; Miller, A.J.; McCaslin, J.B.; Coulson, L.V.

    1988-04-01

    It is hoped that this manual will serve both as a teaching aid as well as a useful adjunct for program development. In the context of application, this manual addresses good practices that should be observed by management, staff, and designers since the achievement of a good radiation program indeed involves a combined effort. Ultimately, radiation safety and good work practices become the personal responsibility of the individual. The practices presented in this manual are not to be construed as mandatory rather they are to be used as appropriate for the specific case in the interest of radiation safety. As experience is accrued and new data obtained in the application of this document, ONS will update the guidance to assure that at any given time the guidance reflects optimum performance consistent with current technology and practice.The intent of this guide therefore is to: define common health physics problems at accelerators; recommend suitable methods of identifying, evaluating, and managing accelerator health physics problems; set out the established safety practices at DOE accelerators that have been arrived at by consensus and, where consensus has not yet been reached, give examples of safe practices; introduce the technical literature in the accelerator health physics field; and supplement the regulatory documents listed in Appendix D. Many accelerator health physics problems are no different than those at other kinds of facilities, e.g., ALARA philosophy, instrument calibration, etc. These problems are touched on very lightly or not at all. Similarly, this document does not cover other hazards such as electrical shock, toxic materials, etc. This does not in any way imply that these problems are not serious. 160 refs.

  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. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  1. 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.

  2. 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.

  3. 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.

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

    SciTech Connect

    Not Available

    1992-07-01

    The purpose of the Department of Energy (DOE) Guide to Good Practices for On-the-Job Training (OJT) is to provide DOE contractor organizations with information that can be used to modify existing programs or to develop new programs. This guide replaces the Guide to Good Practices for On-the-Job Training that was distributed to DOE and DOE contractors in 1987. DOE contractors should not feel obligated to adopt all parts of this guide. Rather, they can use the information in this guide to develop programs that apply to their facility. This guide can be used as an aid in the design and development of a facility's OJT programs and to assist the instructors who conduct OJT and performance tests in the areas of facility operations, maintenance, and technical supports.

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

    PubMed

    Rodríguez-Dorta, Manuela; Borges, África

    2017-01-01

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

  6. Behavioral Patterns in Special Education. Good Teaching Practices

    PubMed Central

    Rodríguez-Dorta, Manuela; Borges, África

    2017-01-01

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

  7. Emergency management training program: Guide to good practice

    SciTech Connect

    Not Available

    1991-07-01

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

  8. Emergency management training program: Guide to good practice

    SciTech Connect

    Not Available

    1991-07-01

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

  9. Good practice in school based alcohol education programmes.

    PubMed

    Thom, Betsy

    2017-01-01

    To identify elements of good practice in designing and delivering alcohol education programmes in schools. Literature reviews and published programme evaluations were used to identify key elements of good practice. Principles of good practive are identified and discussed. Five main issues are highlighted: choosing a universal or targetted approach, the need for theoretical frameworks, adopting a stand-alone or multi-component approach; issues of delivery and programme fidelity, and balancing programme fidelity and cultural relevance. Programme objectives, programme fidelity and cultural context are important factors in designing programmes and will influence outcomes and evaluation of success. In developing alcohol education programmes, there is a need to draw on the evidence and experience accrued from previous efforts. Programme development and implementation can draw on results from evaluated programmes to design alcohol education programmes suited to specific contexts, the availability of resources, the perceived needs of the target group and the problem to be addressed. Copyright © 2016. Published by Elsevier B.V.

  10. 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.

  11. 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

  12. 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.

  13. Commentary on the MID3 Good Practices Paper

    PubMed Central

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

    2017-01-01

    During the last 10 years the European Medicines Agency (EMA) organized a number of workshops on modeling and simulation, working towards greater integration of modeling and simulation (M&S) in the development and regulatory assessment of medicines. In the 2011 EMA – European Federation of Pharmaceutical Industries and Associations (EFPIA) Workshop on Modelling and Simulation, European regulators agreed to the necessity to build expertise to be able to review M&S data provided by companies in their dossier. This led to the establishment of the EMA Modelling and Simulation Working Group (MSWG). Also, there was agreement reached on the need for harmonization on good M&S practices and for continuing dialog across all parties. The MSWG acknowledges the initiative of the EFPIA Model‐Informed Drug Discovery and Development (MID3) group in promoting greater consistency in practice, application, and documentation of M&S and considers the paper is an important contribution towards achieving this objective. PMID:28653481

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

    ERIC Educational Resources Information Center

    Hermans, Chris

    2017-01-01

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

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

    PubMed

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

    2013-01-01

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

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

    PubMed Central

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

    2013-01-01

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

  17. 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.

  18. [Good Practice of Secondary Data Analysis (GPS): guidelines and recommendations].

    PubMed

    Swart, E; Gothe, H; Geyer, S; Jaunzeme, J; Maier, B; Grobe, T G; Ihle, P

    2015-02-01

    In 2005, the Working Group for the Survey and Utilisation of Secondary Data (AGENS) of the German Society for Social Medicine and Prevention (DGSMP) and the German Society for Epidemiology (DGEpi) first published "Good Practice in Secondary Data Analysis (GPS)" formulating a standard for conducting secondary data analyses. GPS is intended as a guide for planning and conducting analyses and can provide a basis for contracts between data owners. The domain of these guidelines does not only include data routinely gathered by statutory health insurance funds and further statutory social insurance funds, but all forms of secondary data. The 11 guidelines range from ethical principles and study planning through quality assurance measures and data preparation to data privacy, contractual conditions and responsible communication of analytical results. They are complemented by explanations and practical assistance in the form of recommendations. GPS targets all persons directing their attention to secondary data, their analysis and interpretation from a scientific point of view and by employing scientific methods. This includes data owners. Furthermore, GPS is suitable to assess scientific publications regarding their quality by authors, referees and readers. In 2008, the first version of GPS was evaluated and revised by members of AGENS and the Epidemiological Methods Working Group of DGEpi, DGSMP and GMDS including other epidemiological experts and had then been accredited as implementation regulations of Good Epidemiological Practice (GEP). Since 2012, this third version of GPS is on hand and available for downloading from the DGEpi website at no charge. Especially linguistic specifications have been integrated into the current revision; its internal consistency was increased. With regards to contents, further recommendations concerning the guideline on data privacy have been added. On the basis of future developments in science and data privacy, further revisions will

  19. Short communication: guidelines to good manufacturing practices (g.m.p.) in pharmaceutical manufacturing.

    PubMed

    Shaikh, R H; Sial, A A

    1995-01-01

    The object of the GMP and associated rules is the assurance of the quality of the products for the safety, well being and protection of the patient. In achieving this aim it is impossible to over-emphasise the importance of people, at all levels, in the assurance of the quality of medicinal products. The great majority of reported defective medicinal products has resulted from human error or carelessness and not from failure in technology. All the people involved with the production, quality control or distribution of medicinal products, whether key personnel, production or quality control staff, inspectors or other involved in the many activities which lead to a patient taking a medicine, should bear this constantly in mind when performing their duties.

  20. Dynamic Learning and Practice. HMIE Early Years Good Practice Conference (December 3, 2007). Conference Report

    ERIC Educational Resources Information Center

    Her Majesty's Inspectorate of Education, 2007

    2007-01-01

    This is the third in a series of Early Years Good Practice conferences provided by Her Majesty's Inspectorate of Education (HMIE). The purpose of these is to support early years practitioners from pre-school and the early years of primary school to share ideas and learn from one another about the practical aspects of managing the continuity of…

  1. 75 FR 16345 - Administrative Practices and Procedures; Good Guidance Practices; Technical Amendment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-01

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 10 (formerly Docket No. 1999N-4783) Administrative Practices and Procedures; Good Guidance Practices; Technical Amendment AGENCY: Food and...

  2. Good practice in health, environment and safety management in enterprise.

    PubMed

    Michalak, J

    2001-01-01

    Good practice in health, environment and safety management in enterprise (GP HESME) is a process that aims at continuous improvement in health, environment and safety performance, involving all stakeholders within and outside the enterprise. This WHO program is supported by other international organizations, and the declaration of Ministers of Health and Ministers of Environment adopted in 1999. The basic issues of the GP HESME concept are presented as well as its prerequisites, benefits and participants. The key partners in GP HESME are employers and their organizations, representatives of employees, governmental agencies, local authorities, financial and insurance institutions, occupational health services, environmental and social services, associations of professionals, research and training institutions. The HESME system is intended to function at different levels: international, national, local community, and enterprise settings. The lists of expected benefits for each group of stakeholders are discussed. Evaluation of GP HESME is based on the criteria and indicators, the most important of them are briefly presented.

  3. Good clinical practice: historical background and key aspects.

    PubMed

    Otte, Andreas; Maier-Lenz, Herbert; Dierckx, Rudi A

    2005-07-01

    Clinical research trials (both academic and industry sponsored) are increasingly playing a role in various medical disciplines, including younger fields of clinical trial interest, such as nuclear medicine research. Knowledge for and compliance with good clinical practice (GCP) is essential for anyone involved. In this review article, key aspects of GCP and the responsibilities of investigators, monitors and sponsors are described. In addition, a comprehensive overview of the historical background on the development of GCP from the US Pure Food and Drugs Act of 1906 over the Nuremberg Code, the Kefauver-Harris Amendments and the Declaration of Helsinki until now is given. Knowledge of the historical background may help understand the developments in GCP.

  4. [Good Laboratory Practice (GPL) and quality control in Dutch laboratories].

    PubMed

    Goudswaard, J

    1991-03-15

    A review of the origin of GLP (Good Laboratory Practice) and ISO (International Standard Organisation) directives is followed by a number of definitions of concepts such as quality, guarantees of quality, quality systems, etc. by laboratories (NEN 2653). These requirements are discussed in the paper. Certification is one of the guarantees of quality assessment by laboratories. Certification of laboratories is carried out by STERLAB (Laboratory Accreditation Board of The Netherlands) or the CCKL (National Coordination Committee for Quality Assurance for Health Care Laboratories in The Netherlands). In addition to certification, laboratories in the Netherlands are extremely active as regards external quality control (QC). QC is carried out by the various occupational groups. The paper finally closes with a discussion of future developments regarding quality control and certification in medical and veterinary diagnostic laboratories.

  5. 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.

  6. 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.

  7. Bioseparation in antibody manufacturing: the good, the bad and the ugly.

    PubMed

    Gottschalk, Uwe

    2008-01-01

    Improvements in upstream production have boosted productivity in the biomanufacturing industry, but this is leading to bottlenecks in downstream processing as current technology platforms reach their limits of throughput and scalability. Although chromatography remains an indispensible component of downstream processing due to its simplicity and high resolving power (The Good), there is virtually no economy of scale effect so more product translates almost linearly into greater production costs. Bind-and-elute processes (such as the initial capture step in antibody manufacturing) are volume-driven and therefore have knock-on effects that impact on the entire production facility since the space required for preparation, storage, and cleaning steps has to be similarly adapted (The Bad). During long-term operations with multiple cycles, thorough cleaning is necessary to prevent progressive fouling and microbial contamination (The Ugly). Innovative solutions are required, which may include revisiting simpler and less expensive separation technologies, the use of disposable modules, and the integration of improved processes that are scalable to cope with increased demands. Among the alternatives that have been put forward, membrane adsorbers are beginning to make a real impact on the industry, particularly for flow-through applications such as polishing and viral clearance.

  8. 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...

  9. 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...

  10. 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...

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

  12. Harmonization of good laboratory practice requirements and laboratory accreditation programs.

    PubMed

    Royal, P D

    1994-09-01

    Efforts to harmonize Good Laboratory Practice (GLP) requirements have been underway through the Organization for Economic Cooperation and Development (OECD) since 1981. In 1985, a GLP panel was established to facilitate the practical implementation of the OECD/GLP program. Through the OECD/GLP program, Memoranda of Understanding (MOU) agreements which foster requirements for reciprocal data and study acceptance and unified GLP standards have been developed among member countries. Three OECD Consensus Workshops and three inspectors training workshops have been held. In concert with these efforts, several OECD countries have developed GLP accreditation programs, managed by local health and environmental ministries. In addition, Canada and the United States are investigating Laboratory Accreditation programs for environmental monitoring assessment and GLP-regulated studies. In the European Community (EC), the need for quality standards specifying requirements for production and international trade has promoted International Standards Organization (ISO) certification for certain products. ISO-9000 standards identify requirements for certification of quality systems. These certification programs may affect the trade and market of laboratories conducting GLP studies. Two goals identified by these efforts are common to both programs: first, harmonization and recognition of requirements, and second, confidence in the rigor of program components used to assess the integrity of data produced and study activities. This confidence can be promoted, in part, through laboratory inspection and screening processes. However, the question remains, will data produced by sanctioned laboratories be mutually accepted on an international basis?(ABSTRACT TRUNCATED AT 250 WORDS)

  13. 2 CFR 176.140 - Award term-Required Use of American Iron, Steel, and Manufactured Goods-Section 1605 of the...

    Code of Federal Regulations, 2010 CFR

    2010-01-01

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

  14. 2 CFR 176.150 - Notice of Required Use of American Iron, Steel, and Manufactured Goods-Section 1605 of the...

    Code of Federal Regulations, 2010 CFR

    2010-01-01

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

  15. 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.

  16. Practical Strategies for Integrating Final Ecosystem Goods and ...

    EPA Pesticide Factsheets

    The concept of Final Ecosystem Goods and Services (FEGS) explicitly connects ecosystem services to the people that benefit from them. This report presents a number of practical strategies for incorporating FEGS, and more broadly ecosystem services, into the decision-making process. Whether a decision process is in early or late stages, or whether a process includes informal or formal decision analysis, there are multiple points where ecosystem services concepts can be integrated. This report uses Structured Decision Making (SDM) as an organizing framework to illustrate the role ecosystem services can play in a values-focused decision-process, including: • Clarifying the decision context: Ecosystem services can help clarify the potential impacts of an issue on natural resources together with their spatial and temporal extent based on supply and delivery of those services, and help identify beneficiaries for inclusion as stakeholders in the deliberative process. • Defining objectives and performance measures: Ecosystem services may directly represent stakeholder objectives, or may be means toward achieving other objectives. • Creating alternatives: Ecosystem services can bring to light creative alternatives for achieving other social, economic, health, or general well-being objectives. • Estimating consequences: Ecosystem services assessments can implement ecological production functions (EPFs) and ecological benefits functions (EBFs) to link decision alt

  17. [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).

  18. 2 CFR 176.160 - Award term-Required Use of American Iron, Steel, and Manufactured Goods (covered under...

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ..., Steel, and Manufactured Goods (covered under International Agreements)-Section 1605 of the American... American Recovery and Reinvestment Act of 2009 § 176.160 Award term—Required Use of American Iron, Steel..., maintenance, or repair of a public building or public work that involves iron, steel, and/or...

  19. 2 CFR 176.160 - Award term-Required Use of American Iron, Steel, and Manufactured Goods (covered under...

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 2 Grants and Agreements 1 2012-01-01 2012-01-01 false Award term-Required Use of American Iron...—Required Use of American Iron, Steel, and Manufactured Goods (covered under International Agreements... construction, alteration, maintenance, or repair of a public building or public work that involves iron, steel...

  20. 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

    ... 2 Grants and Agreements 1 2011-01-01 2011-01-01 false Notice of Required Use of American Iron... American Recovery and Reinvestment Act of 2009 § 176.170 Notice of Required Use of American Iron, Steel... work, and involve iron, steel, and/or manufactured goods covered under international agreements, the...

  1. 2 CFR 176.160 - Award term-Required Use of American Iron, Steel, and Manufactured Goods (covered under...

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 2 Grants and Agreements 1 2014-01-01 2014-01-01 false Award term-Required Use of American Iron... American Iron, Steel, and Manufactured Goods (covered under International Agreements)—Section 1605 of the..., alteration, maintenance, or repair of a public building or public work that involves iron, steel, and/or...

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

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 2 Grants and Agreements 1 2013-01-01 2013-01-01 false Award term-Required Use of American Iron...—Required Use of American Iron, Steel, and Manufactured Goods (covered under International Agreements... construction, alteration, maintenance, or repair of a public building or public work that involves iron, steel...

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

    USDA-ARS?s Scientific Manuscript database

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

  4. Good clinical practice in resource-limited settings: translating theory into practice.

    PubMed

    Tinto, Halidou; Noor, Ramadhani A; Wanga, Charles L; Valea, Innocent; Mbaye, Maimouna Ndour; D'Alessandro, Umberto; Ravinetto, Raffaella M

    2013-04-01

    A Good Clinical Practices (GCPs) course, based on the combination of theoretical modules with a practical training in real-life conditions, was held in 2010 in Burkina Faso. It was attended by 15 trainees from nine African, Asian, and Latin American countries. There were some discrepancies between the average good results at the end of the theoretical phase and the GCP application during the first days of the practical phase, underlying the difficulties of translating theoretical knowledge into good practices. Most of the findings were not unexpected and reflected the challenges commonly faced by clinical investigators in resource-poor contexts (i.e., the high workload at peripheral health facilities, the need to conciliate routine clinical activities with clinical research, and the risk of creating a double standard among patients attending the same health facility [free care for recruited patients versus user fees for non-recruited patients with the same medical condition]). Even if limited in number and time, these observations suggest that a theoretical training alone may not be sufficient to prepare trainees for the challenges of medical research in real-life settings. Conversely, when a practical phase immediately follows a theoretical one, trainees can immediately experience what the research methodology implicates in terms of work organization and relationship with recruited and non-recruited patients. This initial experience shows the complexity of translating GCP into practice and suggests the need to rethink the current conception of GCP training.

  5. Gene transfer: regulatory issues and their impact on the clinical investigator and the good manufacturing production facility.

    PubMed

    Grilley, B J; Gee, A P

    2003-01-01

    The first human gene-transfer study was submitted to the Recombinant DNA Advisory Committee (RAC) in 1988, thus initiating a new era in clinical research. As per the RAC Website (last updated 22nd November 2002), almost 550 human gene-transfer studies have been submitted to the RAC. However, there are currently no licensed gene-therapy products available in the USA. The natural evolution of the review process to accommodate these novel protocols, as well as the death of Jesse Gelsinger in 1999, have led to significant changes in the initial and ongoing review of gene-transfer studies. However, the basic framework of the review process remains unchanged.Gene-transfer protocols require oversight by the Food and Drug Administration (FDA), the Recombinant DNA Advisory Committee (RAC), the Institutional Biosafety Committee (IBC), and the Institutional Review Board (IRB). Such oversight includes both initial review of the protocol and ongoing review of the study through the review of annual reports, adverse events, and proposed amendments to the study. In addition to such review of the protocol, the product itself is required by the FDA to be prepared under current good manufacturing practices (cGMP). This article discusses both regulatory oversight and current GMP issues in depth.

  6. [Decree on the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use].

    PubMed

    Schwerdtfeger, W K

    2005-02-01

    In Germany, Directive 2001/20/EC is implemented by articles 40 to 42a of the Federal Drug Act and by the Decree on Good Clinical Practice. Pivotal provisions have been included into the Federal Drug Act, such as those aiming at the clinical trial subject's protection and defining responsibilities for the evaluation of applications as well as for pharmacovigilance and surveillance. The Decree comprises: relevant definitions; requirements for manufacturing, importation and labelling of investigational medicinal products; the procedures to obtain the ethics committee's opinion and the authorization from the competent authority on the trial application and on amendments thereof; documentation and information tasks of the investigator, sponsor and competent authority; rules for inspection to verify compliance with good clinical and manufacturing practice. Finally, the decree lists infringements within the meaning of article 97, paragraph 2, no. 31 of the Federal Drug Act, and lays down the necessary provisions for a transitional period and the entering into force of the new provisions.

  7. 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.

  8. 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…

  9. 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…

  10. 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

  11. 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.

  12. [The IDEFICS primary prevention as a good practice example].

    PubMed

    Pigeot, Iris; De Henauw, Stefaan; Ahrens, Wolfgang

    2016-11-01

    Worldwide the prevalence of childhood overweight and obesity is strikingly high. Prevention programs are therefore of high priority at a national and international level. In the framework of the IDEFICS study a primary prevention program was developed, implemented and evaluated. This paper investigates to what degree the IDEFICS intervention may serve as good practice example. For this purpose, the single modules are described and the achieved effects are discussed. In eight European countries 16,228 children aged 2 to 9.9 years were recruited from kindergartens and schools. About half of them participated in a primary prevention program. In each country the intervention region was matched to a control region with a similar socio-demographic profile. All children participated in an extensive examination program at baseline, which was repeated two years later to assess the development of the children and the intervention effects. In addition, a further follow-up examination took place five years after the intervention in the framework of the I.Family study. After two years the IDEFICS intervention showed only minor effects on an individual level, but sustainable effects on the community and the setting level. After five years a beneficial change in the consumption of sugar and water could be observed in the intervention families and children who were overweight and obese at baseline showed favorable weight trajectories. The reasons for the weak intervention effects may be, among others, due to the limited penetration of intervention messages, an insufficient intensity of local intervention activities and our limited ability to induce structural changes of the obesogenic environment.

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

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... viruses, bacteria, fungi, parasites, and transmissible spongiform encephalopathy agents. CGTP requirements govern the methods used in, and the facilities and controls used for, the manufacture of HCT/Ps... § 1271.190(a) and (b); (2) Requirements relating to environmental control in § 1271.195(a); (3...

  14. 21 CFR 1271.150 - Current good tissue practice requirements.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... viruses, bacteria, fungi, parasites, and transmissible spongiform encephalopathy agents. CGTP requirements govern the methods used in, and the facilities and controls used for, the manufacture of HCT/Ps... § 1271.190(a) and (b); (2) Requirements relating to environmental control in § 1271.195(a); (3...

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

    PubMed

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

    2017-01-01

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

  16. 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…

  17. 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…

  18. Addressing the challenge of diversity in the graduate ranks: good practices yield good outcomes.

    PubMed

    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 the Division of Biology and Medicine, would have a positive effect on underrepresented minority (URM) recruitment and retention and objective measures of student success. These practices include: 1) develop strategic partnerships with selected undergraduate institutions; 2) provide a personalized education program of student support and skill-based modules to supplement discipline-based course work; and 3) transform institutional culture by engaging faculty in supporting diversity-related goals and practices. Data comparing URM numbers and key academic milestones before and after implementation of IMSD practices support the initial hypothesis and effectiveness of these practices at Brown. Program components are broadly applicable as best practices for others seeking to improve URM recruitment and achievements of graduate students traditionally underrepresented in the sciences.

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

    PubMed Central

    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 the Division of Biology and Medicine, would have a positive effect on underrepresented minority (URM) recruitment and retention and objective measures of student success. These practices include: 1) develop strategic partnerships with selected undergraduate institutions; 2) provide a personalized education program of student support and skill-based modules to supplement discipline-based course work; and 3) transform institutional culture by engaging faculty in supporting diversity-related goals and practices. Data comparing URM numbers and key academic milestones before and after implementation of IMSD practices support the initial hypothesis and effectiveness of these practices at Brown. Program components are broadly applicable as best practices for others seeking to improve URM recruitment and achievements of graduate students traditionally underrepresented in the sciences. PMID:23463225

  20. 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…

  1. 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…

  2. 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…

  3. 48 CFR 52.225-23 - 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 Under Trade Agreements. 52....225-23 Required Use of American Iron, Steel, and Manufactured Goods—Buy American Act—Construction... American Iron, Steel, and Manufactured Goods—Buy American Act—Construction Materials Under Trade...

  4. 48 CFR 52.225-23 - 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 Under Trade Agreements. 52....225-23 Required Use of American Iron, Steel, and Manufactured Goods—Buy American Act—Construction... American Iron, Steel, and Manufactured Goods—Buy American Act—Construction Materials Under Trade...

  5. 48 CFR 52.225-23 - 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 Under Trade Agreements....225-23 Required Use of American Iron, Steel, and Manufactured Goods—Buy American Statute—Construction... American Iron, Steel, and Manufactured Goods—Buy American Statute—Construction Materials Under...

  6. 48 CFR 52.225-23 - 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 Under Trade Agreements. 52....225-23 Required Use of American Iron, Steel, and Manufactured Goods—Buy American Act—Construction... American Iron, Steel, and Manufactured Goods—Buy American Act—Construction Materials Under Trade...

  7. 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...

  8. 48 CFR 52.225-21 - Required Use of American Iron, Steel, and Manufactured Goods-Buy American Statute-Construction...

    Code of Federal Regulations, 2014 CFR

    2014-10-01

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

  9. 48 CFR 52.225-24 - Notice of Required Use of American Iron, Steel, and Manufactured Goods-Buy American Statute...

    Code of Federal Regulations, 2014 CFR

    2014-10-01

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

  10. 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 Act—Construction...

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

    Code of Federal Regulations, 2013 CFR

    2013-10-01

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

  12. 48 CFR 52.225-22 - Notice of Required Use of American Iron, Steel, and Manufactured Goods-Buy American Statute...

    Code of Federal Regulations, 2014 CFR

    2014-10-01

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

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

    Code of Federal Regulations, 2012 CFR

    2012-10-01

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

  14. 48 CFR 52.225-21 - Required Use of American Iron, Steel, and Manufactured Goods-Buy American Act-Construction...

    Code of Federal Regulations, 2011 CFR

    2011-10-01

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

  15. 48 CFR 52.225-24 - Notice of Required Use of American Iron, Steel, and Manufactured Goods-Buy American Act...

    Code of Federal Regulations, 2013 CFR

    2013-10-01

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

  16. 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 Act—Construction...

  17. Good Practice in Transcultural Counselling: An Asian Perspective.

    ERIC Educational Resources Information Center

    Johnson, Amanda Webb; Nadirshaw, Zenobia

    1993-01-01

    Addresses the therapeutic needs of South Asian communities in Great Britain. Challenges assumptions and beliefs held by therapists and counselors, and provides some guidelines for transcultural counseling practices. (JPS)

  18. Validation of analytical methods in compliance with good manufacturing practice: a practical approach

    PubMed Central

    2013-01-01

    Background The quality and safety of cell therapy products must be maintained throughout their production and quality control cycle, ensuring their final use in the patient. We validated the Lymulus Amebocyte Lysate (LAL) test and immunophenotype according to International Conference on Harmonization Q2 Guidelines and the EU Pharmacopoeia, considering accuracy, precision, repeatability, linearity and range. Methods For the endotoxin test we used a kinetic chromogenic LAL test. As this is a limit test for the control of impurities, in compliance with International Conference on Harmonization Q2 Guidelines and the EU Pharmacopoeia, we evaluated the specificity and detection limit. For the immunophenotype test, an identity test, we evaluated specificity through the Fluorescence Minus One method and we repeated all experiments thrice to verify precision. The immunophenotype validation required a performance qualification of the flow cytometer using two types of standard beads which have to be used daily to check cytometer reproducibly set up. The results were compared together. Collected data were statistically analyzed calculating mean, standard deviation and coefficient of variation percentage (CV%). Results The LAL test is repeatable and specific. The spike recovery value of each sample was between 0.25 EU/ml and 1 EU/ml with a CV% < 10%. The correlation coefficient (≥ 0.980) and CV% (< 10%) of the standard curve tested in duplicate showed the test's linearity and a minimum detectable concentration value of 0.005 EU/ml. The immunophenotype method performed thrice on our cell therapy products is specific and repeatable as showed by CV% inter -experiment < 10%. Conclusions Our data demonstrated that validated analytical procedures are suitable as quality controls for the batch release of cell therapy products. Our paper could offer an important contribution for the scientific community in the field of CTPs, above all to small Cell Factories such as ours, where it is not always possible to have CFR21 compliant software. PMID:23981284

  19. 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

  20. 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…

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

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... Section 73.508 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) BROADCAST RADIO SERVICES RADIO BROADCAST SERVICES Noncommercial Educational FM Broadcast Stations § 73.508 Standards of good... watts transmitter power output shall be subject to all of the provisions of the FM Technical...

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

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... Section 73.508 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) BROADCAST RADIO SERVICES RADIO BROADCAST SERVICES Noncommercial Educational FM Broadcast Stations § 73.508 Standards of good... watts transmitter power output shall be subject to all of the provisions of the FM Technical...

  3. 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…

  4. 2 CFR 176.150 - Notice of Required Use of American Iron, Steel, and Manufactured Goods-Section 1605 of the...

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 2 Grants and Agreements 1 2014-01-01 2014-01-01 false Notice of Required Use of American Iron... Reinvestment Act of 2009 § 176.150 Notice of Required Use of American Iron, Steel, and Manufactured Goods... repair of a public building or public work, and do not involve iron, steel, and/or manufactured goods...

  5. 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

  6. 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,…

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

    SciTech Connect

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

    2006-04-01

    The Pearl River Delta is a major manufacturing region on the south coast of China that produces more than $100 billion of goods annually for export to North America, Europe, and other parts of Asia. Considerable air pollution is caused by the manufacturing industries themselves and by the power plants, trucks, and ships that support them. It is estimated that 10-40% of emissions of primary SO{sub 2}, NOx, RSP, and VOC in the region are caused by export-related activities. Using the STEM-2K1 atmospheric transport model, it is estimated that these emissions contribute 5-30% of the ambient concentrations of SO{sub 2}, NOx, NOz, and VOC in the region. (NO{sub Z}=PAN, HONO, HNO{sub 3}, N{sub 2}O{sub 5} and organic nitrates). One reason that the exported goods are cheap and therefore attractive to consumers in developed countries is that emission controls are lacking or of low performance. It is estimated that state-of-the-art controls could be installed at an annualized cost of $0.3-3 billion, representing 0.3-3% of the value of the goods produced. Mitigation measures could be adopted without seriously affecting the prices of exported goods and would achieve considerable human health and other benefits in the form of reduced air pollutant concentrations in densely populated urban areas. 22 refs., 5 figs., 5 tabs.

  8. 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…

  9. 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…

  10. Considering the Physical Environment: An Essential Component of Good Practice.

    ERIC Educational Resources Information Center

    Gutheil, Irene A.

    1992-01-01

    Discusses physical environment and its effect on behavior. Reviews theories about impact of space organization and concepts useful to understanding people's relationships with their environments. Focuses on application of theory about people's physical settings to social work practice. Presents case examples, reviews skills for translating…

  11. Professional Learning in Higher Education: Making Good Practice Relevant

    ERIC Educational Resources Information Center

    Daniels, Jeannie

    2017-01-01

    Professionals working in a range of contexts are increasingly expected to engage in ongoing professional learning to maintain their skills and develop their practices. In this paper, I focus on professional learning in Higher Education and challenge the standardisation of professional learning that is becoming prevalent in a number of countries. I…

  12. 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…

  13. 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…

  14. 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.

  15. A compilation of Good Laboratory Practice questions and (where to get the) answers.

    PubMed

    Mayer, D E; Purdue, T W

    1995-12-01

    Since the inception of the Food and Drug Administration's Good Laboratory Practice Regulations and Environmental Protection Agency's Good Laboratory Practice Standards, many "questions and answer" documents have been produced. Our purpose in this presentation is to pull together some of these reference documents and provide a cross-reference index to sort through the many topics and questions. The combined reference resource and index provide the quality assurance professional a useful Good Laboratory Practice information tool.

  16. 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.

  17. 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.

  18. Reducing DfM to practice: the lithography manufacturability assessor

    NASA Astrophysics Data System (ADS)

    Liebmann, Lars; Mansfield, Scott; Han, Geng; Culp, James; Hibbeler, Jason; Tsai, Roger

    2006-03-01

    The need for accurate quantification of all aspects of design for manufacturability using a mutually compatible set of quality-metrics and units-of-measure, is reiterated and experimentally verified. A methodology to quantify the lithography component of manufacturability is proposed and its feasibility demonstrated. Three stages of lithography manufacturability assessment are described: process window analysis on realistic integrated circuits following layout manipulations for resolution enhancement and the application of optical proximity correction, failure sensitivity analysis on simulated achievable dimensional bounds (a.k.a. variability bands), and yield risk analysis on iso-probability bands. The importance and feasibility of this technique is demonstrated by quantifying the lithography manufacturability impact of redundant contact insertion and Critical Area optimization in units that can be used to drive an overall layout optimization. The need for extensive experimental calibration and improved simulation accuracy is also highlighted.

  19. 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.

  20. Developing good scientific publishing practices: one pharmaceutical company's perspective.

    PubMed

    Dowsett, Sherie A; Van Campen, Luann E; Bednar, Lisa A

    2010-06-01

    The scientific publishing practices of the pharmaceutical industry have been heavily criticized in recent years due to the inherent conflict of interest that arises when a pharmaceutical company publishes findings around its own drugs. Eli Lilly and Company ('Lilly') strives for transparency in its day-to-day activities, and, here, shares its principles, policies and practices on publishing "Lilly-sponsored" research. A conflict of interest does not necessarily equate to biased presentation of research findings, and operating a successful, for-profit business and maintaining a focus on improving the health of patients are not mutually exclusive goals. There is, however, potential for bias, and it is incumbent upon a for-profit to develop publication principles, policies and practices to address this. To this end, Lilly's Principles of Medical Research states that 'Lilly discloses publicly all medical research results that are important to patients, healthcare providers or payers--whether favorable or unfavorable to a Lilly product--in an accurate, objective, and balanced manner ...' The preparation of publications of Lilly-sponsored research involves close collaboration between external (i.e., academic or otherwise non-industry employees) and Lilly scientific researchers (including scientific writers), with both serving as authors. Lilly does not support 'ghost' or 'guest' authorship. Authorship is not just recognition of contribution but also public acknowledgement of responsibility for content, and all authors are expected to take an active role in developing the manuscript in line with the International Committee of Medical Journal Editors-based authorship requirements. This is agreed to by authors before the manuscript is started. Lilly provides external authors with access to the trial data for manuscript development. Lilly does not pay external authors for their involvement in manuscript development. Scientific writers at Lilly, often with advanced scientific

  1. 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.

  2. 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.

  3. Trauma informed care: a radical shift or basic good practice?

    PubMed

    Isobel, Sophie

    2016-12-01

    There is significant multidisciplinary work contributing to the implementation of trauma informed care (TIC) into mental health policy and practice in Australia. Within psychiatry, there may be potential confusion about how to navigate the integration of TIC into a speciality built upon treating psychological distress; creating dismissive reactions of a patronising approach and paradoxical radicalism. This paper aims to discuss the need for psychiatry to view TIC as a significant and urgent paradigm shift required to integrate existing knowledge about the prevalence and effects of trauma into a progressive articulation of the relational and interpersonal underpinnings of modern psychiatric practice; and to lead and support its widespread implementation. Active consideration of the intent of TIC may aid in reducing misunderstanding and misaligned resistance while allowing services and individuals an important opportunity to reflect on how to deliver mental health treatment that is universally sensitive to the dynamics of trauma in the care environment. © The Royal Australian and New Zealand College of Psychiatrists 2016.

  4. 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.

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

    PubMed

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

    2015-12-01

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

  6. 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

  7. Good practices in collecting umbilical cord and placental blood.

    PubMed

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

    2016-08-18

    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. 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). 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. 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. identificar fatores relacionados à qualidade das amostras do sangue de cordão umbilical e placentário e definir boas práticas para sua coleta em um banco público de sangue de cordão umbilical e placentário. pesquisa descritiva, abordagem quantitativa, realizada em um banco público de sangue de cordão umbilical e placentário, desenvolvida em duas etapas: 1) verificação dos fatores obstétricos, neonatais e operacionais, obtidos por coleta em instrumento próprio e observação não participante; 2) definição das boas práticas, por meio do agrupamento de não-conformidades observadas antes, durante e após a coleta do sangue. Os dados foram analisados por meio da estatística descritiva, utilizando-se dos softwares Statistica(r) e R(r). houve

  8. [Good practice guidelines for the treatment of autistic spectrum disorders].

    PubMed

    Fuentes-Biggi, J; Ferrari-Arroyo, M J; Boada-Muñoz, L; Touriño-Aguilera, E; Artigas-Pallarés, J; Belinchón-Carmona, M; Muñoz-Yunta, J A; Hervás-Zúñiga, A; Canal-Bedia, R; Hernández, J M; Díez-Cuervo, A; Idiazábal-Aletxa, M A; Mulas, F; Palacios, S; Tamarit, J; Martos-Pérez, J; Posada-De la Paz, M

    Due to the inexistence of an aetiology-based intervention for autistic spectrum disorders (ASD) families and professionals are exposed to diverse and sometimes conflictive recommendations when they have to decide the most adequate alternative for treatment. To elaborate treatment guidelines agreed by consensus at the ASD Study Group of the (National) Institute of Health Carlos III. Information about treatment of ASD was searched and gathered through available evidence based medical (EBM) databases. The data generated was complemented with practice parameters published elsewhere, reports from prestigious international institutions, focus oriented searches in PubMed and, finally, the opinion and experience of a multidisciplinary Study Group with extensive experience in treating ASD in Spain. Most popular treatment methods were reviewed as well as the common elements to be considered in successful support programs. No simple treatment algorithm can be produced at this time, and the level of available evidence based recommendations are in the weaker degrees of EBM classifications. Nevertheless, there is widespread agreement to stress that education, with special incidence in the development of communication and social competence, with the addition of community support are the main means of treatment. They can be complemented, depending on individual needs, with medication, behavioural approaches and cognitive-behavioural therapy for associated psychological problems in persons with higher cognitive level. Support to families and community empowerment are essential elements for the quality of life of persons with ASD.

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

    NASA Astrophysics Data System (ADS)

    Jais, Azlina Mohammad; Hassan, Najwa

    2017-01-01

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

  10. 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…

  11. 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.…

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

    ERIC Educational Resources Information Center

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

    2014-01-01

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

  13. 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.…

  14. 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…

  15. 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…

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

    PubMed Central

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

    2016-01-01

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

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

    PubMed

    Draksiene, Gailute

    2002-01-01

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

  18. 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.

  19. The seven principles of good practice: applications for online education in nursing.

    PubMed

    Koeckeritz, Jane; Malkiewicz, Judy; Henderson, Ann

    2002-01-01

    Traditional education has been studied over time for the purpose of documenting what constitutes good practice in teaching. Online education in nursing is still relatively new and has not endured the same scrutiny as classroom education. The authors discuss how Chickering and Gamson's Seven Principles of Good Practice for Undergraduate Education apply to online nursing education and provide practical examples of how the principles can be implemented in Web-based nursing courses.

  20. [Good practice is a means for preventing fraud in clinical research].

    PubMed

    Maisonneuve, H

    1996-01-01

    The aim of this article is to present the findings concerning scientific fraud that have appeared in case reports. Deliberate scientific fraud does exist. The fact that most of the documented cases have occurred in Anglo-Saxon countries seems to indicate, not that Anglo-Saxons are more prone to scientific fraud, but rather that they have been more successful in bringing it to light. Since 1974, 72 cases have been reported in which there was either conclusive evidence or else a strong presumption of fraud: one case in Switzerland, one in Canada, four in Australia, 14 in Great Britain and 52 in the United States. Fraud is estimated to affect 2-5% of clinical research trials. Referees and readers do not set out to track fraud. The American Commission has proposed the terms "misappropriation, interference, misrepresentation" to define fraud. Voluntary fraud is hidden and its detection delayed. In well-known cases, more than 5 years elapsed before the information reached the scientific community. Whistle blowers must sustain a determined effort to denounce fraud over a period of 1-3 years if they are to trigger an investigation. Some whistle blowers have themselves been accused of fraud because their claims proved so embarrassing. Fraud can lead to severe accidents and generate expenditure that those responsible, or the institutions they work for, will never pay back. Frauders are usually motivated by the desire for material gain or the desire to become well-known. The motivating factor may be personal enrichment, or a need for funds for a not-for-profit association. People found guilt of fraud always have good excuses. Some simply do not realize what they have done. A knowledge of research methodology and critical appraisal methods can help to prevent fraud. Good clinical, laboratory and manufacturing practice can help to prevent misconduct and trickery. Audits and inspections are another essential means of combatting fraud.

  1. 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,...

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

    Code of Federal Regulations, 2011 CFR

    2011-10-01

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

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

    Code of Federal Regulations, 2012 CFR

    2012-10-01

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

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

    Code of Federal Regulations, 2013 CFR

    2013-10-01

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

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

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 2 Grants and Agreements 1 2011-01-01 2011-01-01 false Notice of Required Use of American Iron... 2009 § 176.150 Notice of Required Use of American Iron, Steel, and Manufactured Goods—Section 1605 of... public building or public work, and do not involve iron, steel, and/or manufactured goods covered under...

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

    PubMed

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

    2017-03-01

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

  7. [Documentation of good distribution practice of medicines and its implementation in Lithuanian drug distribution companies].

    PubMed

    Draksiene, Gailute; Petkevicius, Henrikas; Radziūnas, Raimondas

    2003-01-01

    Good Distribution Practice of medicinal products for human use is a quality warranty system, which includes requirements for purchase, receiving, storage and export of drugs, intended human consumption. A drug is a specific product and its mishandling is dangerous to human health and life. Therefore it is necessary to strictly control the movement of the drug from the producer to the consumer so that poor quality drugs do not have access to the market. Good Distribution Practice rules set the general requirements for good wholesale distribution practice of drugs, intended for human consumption. In order for company to meet the specified requirements, the drug distribution company must have all suitable and necessary premises, machinery, equipment, the required number of employees and specified documentation. The preparation of the Good Distribution Practice documentation is one of the most important and complex aspects when implementing the Good Distribution Practice in the companies. The article deals with the analysis of results obtained during the research of drug distribution companies in Lithuania. The research revealed that drug distribution companies put emphasis on the equipment of storage premises. Less attention is being paid to the preparation of the documents of Good Distribution Practice. The article thus presents the analysis of Good Distribution Practice documents prepared by the drug distribution companies.

  8. 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.

  9. The practical aspects of quality assurance in Good Laboratory Practice studies in an emergency situation.

    PubMed

    Nomura, A; Takahashi, T

    1995-12-01

    In this report, the damage and countermeasures taken in relation to the Great Hanshin Earthquake are described. We report on the measures taken to counter damage in affected Good Laboratory Practice (GLP) studies by citing concrete examples. Case A: the testing facility was not affected, but a regulatory inspection had been scheduled for this day. Fortunately, official inspectors had reached the facility on schedule. Case B: The building for toxicology experiments was destroyed. Fortunately, most of the GLP-compliant experiments had been completed except one, the preparation of histological samples that was the last stage of the experiment. We asked the regulatory authority for appropriate countermeasures. The answer was that an inspection of the study could be conducted if an inspection is judged to be necessary. Case C: A necropsy was scheduled on this day. The study director decided that the necropsy should be postponed at least 1 week until he could secure the number of researchers needed to conduct the necropsy. Case D: The facility in Itami was destroyed. The facility was closed and the animals were moved to Kobe. The animal facility in Kobe was not affected, but because water supply stopped for 3 days, stocked water was used. Case E: Damage to computer systems in Kinki area was reported. Numerous computers fell from desks or were damaged from the impact shock. With the exception of a few, most of the damaged computers were repaired.

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

    NASA Astrophysics Data System (ADS)

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

    2017-03-01

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

  11. Serum eye drop preparation in Australia: Current manufacturing practice.

    PubMed

    Marks, Denese C; Fisher, Jenny; Mondy, Phillip; Segatchian, Jerard; Dennington, Peta M

    2015-08-01

    Serum eye drops are used to treat diseases such as dry eye syndrome (keratoconjunctivitis sicca), a disease of the surface of the eye that results in an unstable tear film. Patients are referred to the Australian Red Cross Blood Service by ophthalmologists for autologous serum eye drops when other therapies such as artificial tears or topical immunosuppressive agents have failed. In order to manufacture autologous serum eye drops, whole blood is collected from the patients using standard blood collection procedures. The blood is then allowed to clot to produce serum and processed into 20% serum eye drops, which are then returned to the patient for their own use. The eye drops are packaged into a long length of tubing, which is then heat-sealed to produce single-use segments. The demand for serum eye drops in Australia is increasing every year, with a 30% increase in the past 12 months.

  12. 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.

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

    Code of Federal Regulations, 2011 CFR

    2011-01-01

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

  14. 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...) Allow no visitors except under controlled conditions to minimize the introduction of Salmonella...

  15. 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,…

  16. 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…

  17. Institutional Inventory: Principles for Good Practice in Undergraduate Education, Fall 1990.

    ERIC Educational Resources Information Center

    Linksz, Donna

    In 1990, a survey of full-time faculty and staff was conducted at Catonsville Community College (CCC) in Maryland to assess perceptions of the college's climate, academic practices, curriculum, faculty, academic and student support services, and facilities. The "Seven Principles for Good Practices in Undergraduate Teaching" instrument was…

  18. Through the Lens of a Good Practice Framework. Looking at Our Workplace Education Programs.

    ERIC Educational Resources Information Center

    Taylor, Maurice

    A research study used trend analysis to examine case studies of 18 workplace literacy programs with a framework of good practice principles as a template to identify trends in practice. Each case study was examined using the nine components identified in the framework: program orientation, program evaluation, partnerships and participation,…

  19. 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…

  20. 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…

  1. 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,…

  2. 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…

  3. 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.

  4. 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.

  5. 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…

  6. 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…

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

    PubMed

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

    2008-12-13

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

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

    PubMed

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

    2015-11-01

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

  9. 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.

  10. 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.

  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. 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…

  13. 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…

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

    PubMed Central

    Overgaard, RV; Ingwersen, SH; Tornøe, CW

    2015-01-01

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

  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. Copyright © 2016 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

  16. 78 FR 4307 - Current Good Manufacturing Practice Requirements for Combination Products

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-22

    ... whether a prefilled syringe would be considered a combination product. (Response) The suggestion that...) (see, e.g., 21 CFR 880.5860). Accordingly, a prefilled syringe is a combination product and subject to... parts from components of syringes. We plan to address distinctions between devices and...

  17. 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 %).

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

    PubMed

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

    2016-09-13

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

  19. 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

    ... 2 Grants and Agreements 1 2014-01-01 2014-01-01 false Award term-Required Use of American Iron... Reinvestment Act of 2009 § 176.140 Award term—Required Use of American Iron, Steel, and Manufactured Goods... construction, alteration, maintenance, or repair of a public building or public work that does not involve iron...

  20. 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

    ... 2 Grants and Agreements 1 2013-01-01 2013-01-01 false Award term-Required Use of American Iron... and Reinvestment Act of 2009 § 176.140 Award term—Required Use of American Iron, Steel, and... that does not involve iron, steel, and/or manufactured goods covered under international agreements...

  1. 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

    ... 2 Grants and Agreements 1 2012-01-01 2012-01-01 false Award term-Required Use of American Iron... and Reinvestment Act of 2009 § 176.140 Award term—Required Use of American Iron, Steel, and... that does not involve iron, steel, and/or manufactured goods covered under international agreements...

  2. Benefits of Good Laboratory Practice as a tool to improve testing.

    PubMed

    Turnheim, D

    1993-11-01

    The Organization for Economic Cooperation and Development (OECD) has promoted Good Laboratory Practice (GLP) since the mid 1970s. This paper describes the development of the concept through international harmonisation, Quality Assurance (QA), and compliance monitoring. Ultimately this process permits Mutual Acceptance of Data (MAD). An important aspect of the OECD's programme is the promotion of related training and information exchange.

  3. 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…

  4. Good Practices in Roma Education in Bulgaria during the Years of Transition

    ERIC Educational Resources Information Center

    Kyuchukov, Hristo

    2007-01-01

    The aim of this paper is to present good educational practices from Bulgaria that relate to Roma education. In the so-called Years of Transition, educational conditions changed considerably. Non-governmental organizations have attempted to promote high-quality education for Roma children. The Bulgarian Ministry of Education has made various…

  5. 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…

  6. 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…

  7. Institutional Selectivity and Good Practices in Undergraduate Education: How Strong Is the Link?

    ERIC Educational Resources Information Center

    Pascarella, Ernest T.; Cruce, Ty; Umbach, Paul D.; Wolniak, Gregory C.; Kuh, George D.; Carini, Robert M.; Hayek, John C.; Gonyea, Robert M.; Zhao, Chun-Mei

    2006-01-01

    Academic selectivity plays a dominant role in the public's understanding of what constitutes institutional excellence or quality in undergraduate education. In this study, we analyzed two independent data sets to estimate the net effect of three measures of college selectivity on dimensions of documented good practices in undergraduate education.…

  8. 9 CFR 147.26 - Procedures for establishing isolation and maintaining sanitation and good management practices...

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... rodent population and other pests under control; (6) Tailor vaccination programs to needs of farm and... 9 Animals and Animal Products 1 2012-01-01 2012-01-01 false Procedures for establishing isolation and maintaining sanitation and good management practices for the control of Salmonella and Mycoplasma...

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

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... rodent population and other pests under control; (6) Tailor vaccination programs to needs of farm and... 9 Animals and Animal Products 1 2014-01-01 2014-01-01 false Procedures for establishing isolation and maintaining sanitation and good management practices for the control of Salmonella and Mycoplasma...

  10. 9 CFR 147.26 - Procedures for establishing isolation and maintaining sanitation and good management practices...

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... rodent population and other pests under control; (6) Tailor vaccination programs to needs of farm and... 9 Animals and Animal Products 1 2013-01-01 2013-01-01 false Procedures for establishing isolation and maintaining sanitation and good management practices for the control of Salmonella and Mycoplasma...

  11. Institutional Selectivity and Good Practices in Undergraduate Education: How Strong Is the Link?

    ERIC Educational Resources Information Center

    Pascarella, Ernest T.; Cruce, Ty; Umbach, Paul D.; Wolniak, Gregory C.; Kuh, George D.; Carini, Robert M.; Hayek, John C.; Gonyea, Robert M.; Zhao, Chun-Mei

    2006-01-01

    Academic selectivity plays a dominant role in the public's understanding of what constitutes institutional excellence or quality in undergraduate education. In this study, we analyzed two independent data sets to estimate the net effect of three measures of college selectivity on dimensions of documented good practices in undergraduate education.…

  12. 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…

  13. 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…

  14. 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…

  15. Empowerment and Voice: Standards of Good Practice in the Employment of Professional Staff in Higher Education

    ERIC Educational Resources Information Center

    American Federation of Teachers, 2006

    2006-01-01

    This document sets forth standards of good practice for the employment of professional staff. These guidelines serve as a blueprint for the appropriate treatment of professional staff based on the principle that recognition and equity must be coupled with job security and professional treatment. This publication is divided into two sections: (1)…

  16. VET Retention in Remote Aboriginal and Torres Strait Islander Communities. Good Practice Guide

    ERIC Educational Resources Information Center

    National Centre for Vocational Education Research (NCVER), 2017

    2017-01-01

    This good practice guide is based on the research project "Enhancing training advantage for remote Aboriginal and Torres Strait Islander learners" by John Guenther et al. on behalf of Ninti One Limited. The project examines five unique and successful vocational education and training (VET) programs in remote areas and identifies how…

  17. 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…

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

    ERIC Educational Resources Information Center

    Lovat, Terence

    2017-01-01

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

  19. 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…

  20. 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…

  1. Women and Training in Europe. Fifty Projects which Challenge Our Traditions. A Compendium of Good Practice.

    ERIC Educational Resources Information Center

    Commission of the European Communities, Brussels (Belgium).

    This document consists of descriptions of 50 projects that were selected as examples of good practice in providing relevant initial and continuing vocational training to women throughout the European Community regardless of their legal status, employment status, and geographic location. The projects are grouped under six key words (motivation,…

  2. Good Practice in Continuing Vocational Education: Financial Control and Encouragement. UCACE Occasional Paper No. 12.

    ERIC Educational Resources Information Center

    Geale, John

    Respondents to a good practice questionnaire (n=27) rated financial administration as the factor most impeding development of continuing vocational education (CVE) in Britain. A discussion paper identified four critical areas for this inquiry: costing, pricing, overheads, and incentives. Of the 30 universities to which the paper was sent, 21…

  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. 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…

  5. 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. © 2016 American Heart Association, Inc.

  6. 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…

  7. The Curriculum Committee: Role, Structure, Duties, and Standards of Good Practice. Adopted Fall 1996.

    ERIC Educational Resources Information Center

    Academic Senate for California Community Colleges, Sacramento.

    Developed in response to the expanding role of faculty in community college governance and curriculum development, this report reviews the role, structure, and duties of local college curriculum committees and presents standards of good practice. Following an introduction, the role of the curriculum committee is described, and relevant sections…

  8. Good Practices in Roma Education in Bulgaria during the Years of Transition

    ERIC Educational Resources Information Center

    Kyuchukov, Hristo

    2007-01-01

    The aim of this paper is to present good educational practices from Bulgaria that relate to Roma education. In the so-called Years of Transition, educational conditions changed considerably. Non-governmental organizations have attempted to promote high-quality education for Roma children. The Bulgarian Ministry of Education has made various…

  9. 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

    ...,'' pivotal efficacy studies must be conducted in accordance with Good Laboratory Practice (GLP) regulations... that is capable of performing pivotal studies under GLP at BSL-4. To break the current choke point in... to routinely perform pivotal studies in accordance with GLP. OCET seeks to support an effort to...

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

    EPA Science Inventory

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

  11. Off to a Good Start: Practical Nutrition for Family Day Care.

    ERIC Educational Resources Information Center

    Strobl, Catherine; Van Domelen, Nancy

    Written for adults and children, this basic nutrition resource book informs parents and day care providers about the importance of good nutrition, aids them in teaching basic nutritional concepts to children, and provides practical ways to use nutrition information in daily life. Some of the key elements include eating guidelines for adults and…

  12. 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)…

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

    PubMed

    Lie, Arve

    2008-08-01

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

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

    PubMed

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

    2016-01-01

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

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

    PubMed

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

    2015-01-01

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

  16. 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.

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

    PubMed

    Gabrielsson, Sebastian; Sävenstedt, Stefan; Olsson, Malin

    2016-10-01

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

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

    PubMed

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

    2014-01-01

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

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

    PubMed Central

    Braunack-Mayer, A

    2005-01-01

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

  20. 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.