Science.gov

Sample records for good manufacture practices

  1. [Drug flow. Good manufacturing practices, good clinical practices].

    PubMed

    Dupin-Spriet, T; Spriet, A

    1991-01-01

    On a worldwide basis, the drug development circuit in clinical trials undergoes a general movement towards improvement which is sensitive to the degree of quality. The methods used to achieve this are found at the interface of Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP). They consist primarily of two types, for which examples are given here: strengthening of controls (verification of the resemblance of test drugs in double-blind comparison by a "jury" and computerized systems of drug accountability), improvement in "compliance with therapy at the site of investigation" (use of more "intelligent" drug packages and labels). PMID:2020929

  2. 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...

  3. 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...

  4. 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...

  5. 21 CFR 110.5 - Current good manufacturing practice.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 2 2011-04-01 2011-04-01 false Current good manufacturing practice. 110.5 Section...) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD General Provisions § 110.5 Current good manufacturing practice. (a) The criteria...

  6. 21 CFR 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...

  7. 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,...

  8. 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,...

  9. 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,...

  10. 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...

  11. 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...

  12. 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,...

  13. 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...

  14. 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...

  15. 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,...

  16. 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...

  17. 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,...

  18. 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,...

  19. 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,...

  20. 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...

  1. 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...

  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 129.1 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... Current good manufacturing practice. The applicable criteria in part 110 of this chapter, as well as...

  3. 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 129.1 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... Current good manufacturing practice. The applicable criteria in part 110 of this chapter, as well as...

  4. 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 129.1 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... Current good manufacturing practice. The applicable criteria in part 110 of this chapter, as well as...

  5. 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 129.1 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... Current good manufacturing practice. The applicable criteria in part 110 of this chapter, as well as...

  6. 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,...

  7. 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...

  8. 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...

  9. 21 CFR 113.5 - Current good manufacturing practice.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 2 2011-04-01 2011-04-01 false Current good manufacturing practice. 113.5 Section 113.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... CONTAINERS General Provisions § 113.5 Current good manufacturing practice. The criteria in §§ 113.10,...

  10. 21 CFR 123.5 - Current good manufacturing practice.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

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

    PubMed

    Allen, Loyd V

    2013-01-01

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

  12. 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...

  13. 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,...

  14. 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...

  15. 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...

  16. 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...

  17. 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...

  18. 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...

  19. 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) FOOD FOR HUMAN CONSUMPTION FISH AND FISHERY PRODUCTS General Provisions § 123.5 Current...

  20. 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) FOOD FOR HUMAN CONSUMPTION FISH AND FISHERY PRODUCTS General Provisions § 123.5 Current...

  1. 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) FOOD FOR HUMAN CONSUMPTION FISH AND FISHERY PRODUCTS General Provisions § 123.5 Current...

  2. 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) FOOD FOR HUMAN CONSUMPTION FISH AND FISHERY PRODUCTS General Provisions § 123.5 Current...

  3. 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

    ... 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.'' This... Manufacturing Practice for Positron Emission Tomography Drugs; Availability AGENCY: Food and Drug...

  4. 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

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

    PubMed

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

    2015-01-01

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

  6. 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)." PMID:20169678

  7. 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...

  8. 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.

  9. Enterobacteriaceae as indicators of good manufacturing practices in rendering plants.

    PubMed

    van Schothorst, M; Oosterom, J

    1984-01-01

    Finished products and samples from the environment of the production line in rendering plants were checked for Enterobacteriaceae and salmonellae. Improvements in hygiene and measures taken to limit multiplication of microorganisms in the dry area of the production lines resulted in reduction of both numbers of Enterobacteriaceae in environmental samples and frequency of their occurrence in finished products. Simultaneously, there was an equivalent reduction of salmonellae positives in environmental samples and finished products. Consequently, the determination of Enterobacteriaceae can be used as an effective tool to assess the improvements in good manufacturing practices. PMID:6721473

  10. 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...

  11. 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...

  12. 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...

  13. 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...

  14. 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...

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

    PubMed

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

    2015-12-01

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

  16. 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...

  17. 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...

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

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

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

    Code of Federal Regulations, 2014 CFR

    2014-04-01

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

  20. 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...

  1. 21 CFR 210.2 - Applicability of current good manufacturing practice regulations.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

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

  2. 21 CFR 210.2 - Applicability of current good manufacturing practice regulations.

    Code of Federal Regulations, 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...

  3. 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...

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

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Applicability of current good manufacturing... AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL § 210.2 Applicability of current good...

  5. 21 CFR 212.2 - What is current good manufacturing practice for PET drugs?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

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

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

    PubMed

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

    2013-01-01

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

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-17

    ... Current Good Manufacturing Practices Framework for Preventing Cross- Contamination; Availability AGENCY... health risks associated with cross-reactivity. Although the existing current good manufacturing practices (CGMP) regulations require separation of manufacturing facilities to avoid cross-contamination, the...

  8. 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.

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

    PubMed Central

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

    2013-01-01

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

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

    PubMed

    Serra, Marta; Roseti, Livia; Bassi, Alessandra

    2015-01-01

    According to the European Regulation EC 1394/2007, the clinical use of Advanced Therapy Medicinal Products, such as Human Bone Marrow Mesenchymal Stem Cells expanded for the regeneration of bone tissue or Chondrocytes for Autologous Implantation, requires the development of a process in compliance with the Good Manufacturing Practices. The Media Fill test, consisting of a simulation of the expansion process by using a microbial growth medium instead of the cells, is considered one of the most effective ways to validate a cell production process. Such simulation, in fact, allows to identify any weakness in production that can lead to microbiological contamination of the final cell product as well as qualifying operators. Here, we report the critical aspects concerning the design of a Media Fill test to be used as a tool for the further validation of the sterility of a cell-based Good Manufacturing Practice-compliant production process. PMID:25096172

  11. 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. PMID:7800642

  12. 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. PMID:10574696

  13. 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. PMID:11709773

  14. 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. PMID:21083425

  15. 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

  16. 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

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

    PubMed

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

    2013-01-01

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

  18. 78 FR 17142 - Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-20

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

  19. 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

    ... Meeting on Proposed Rule AGENCY: Food and Drug Administration, HHS. ACTION: Notification of public meeting... proposed rule to establish requirements for current good manufacturing practice and hazard analysis and risk-based preventive controls for animal food. This proposed rule is one of several proposed...

  20. 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.

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

    PubMed

    2014-06-10

    The Food and Drug Administration (FDA or we) is issuing a final rule that adopts, with some modifications, the interim final rule (IFR) entitled "Current Good Manufacturing Practices, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports, for Infant Formula'' (February 10, 2014). This final rule affirms the IFR's changes to FDA's regulations and provides additional modifications and clarifications. The final rule also responds to certain comments submitted in response to the request for comments in the IFR. PMID:24922980

  2. 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

    .... The guidance is intended for any HCT/P establishment that performs a manufacturing step and is... 1271, subpart E. The guidance is intended for any HCT/P establishment that performs a manufacturing... 16, 2009 (74 FR 3055), FDA announced the availability of the draft guidance of the same title...

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

    PubMed

    Van Pham, Phuc; Phan, Ngoc Kim

    2015-01-01

    Human umbilical cord blood-derived mesenchymal stem cells (UCB-MSCs) are multipotent stem cells that can be differentiated into several specific cell types such as adipocytes, osteoblasts, and chondroblasts. They also were demonstrated to trans-differentiate into other cell lineages such as muscle cells and neurons. Thus, they are considered a promising stem cell source for therapeutic use. Here, we describe a method for production of good manufacturing practice-grade human UCB-MSCs for therapeutic use. The obtained UCB-MSCs are free of allogenous or xenogenous proteins. In addition, these MSCs could maintain the MSC phenotype in long-term culture. PMID:25239529

  4. 78 FR 4307 - Current Good Manufacturing Practice Requirements for Combination Products

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-22

    ... Register of October 4, 2004 (69 FR 59239), the Agency announced the availability of a Draft Guidance for... 23, 2009 (74 FR 48423), as part of FDA's ongoing effort to improve the consistency and aid... constituent parts that are manufactured and marketed separately from one another (see 74 FR 48423 at 48424...

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

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

    PubMed

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

    2013-07-01

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

  11. 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

  12. 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. PMID:26075255

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

    PubMed

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

    2015-01-01

    Manufacturing of 64Cu-1,4,7,10-tetraazacyclododecane-N,N',N'',N'''-tetraacetic acid (DOTA)-rituximab injection under good manufacturing practices (GMP) was validated for imaging of patients with CD20+ B-cell non-Hodgkin lymphoma. Rituximab was purified by size exclusion high performance liquid chromatography (HPLC) and conjugated to DOTA-mono-(N-hydroxysuccinimidyl) ester. 64CuCl2, buffers, reagents, and other raw materials were obtained as high-grade quality. Following a semi-automated synthesis of 64Cu-DOTA-rituximab, a series of quality control tests was performed. The product was further tested in vivo using micro-positron emission tomography/computed tomography (PET/CT) to assess targeting ability towards human CD20 in transgenic mice. Three batches of 64Cu-DOTA-rituximab final product were prepared as per GMP specifications. The radiolabeling yield from these batches was 93.1 ± 5.8%; these provided final product with radiopharmaceutical yield, purity, and specific activity of 59.2 ± 5.1% (0.9 ± 0.1 GBq of 64Cu), > 95% (by HPLC and radio-thin layer chromatography), and 229.4 ± 43.3 GBq/µmol (or 1.5 ± 0.3 MBq/µg), respectively. The doses passed apyrogenicity and human serum stability specifications, were sterile up to 14 days, and retained > 60% immunoreactivity. In vivo micro-PET/CT mouse images at 24 hours postinjection showed that the tracer targeted the intended sites of human CD20 expression. Thus, we have validated the manufacturing of GMP grade 64Cu-DOTA-rituximab for injection in the clinical setting. PMID:25762106

  14. Good Practices for Hood Use.

    ERIC Educational Resources Information Center

    Mikell, William G.; Drinkard, William C.

    1984-01-01

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

  15. 78 FR 16824 - Tobacco Product Manufacturing Practice; Establishment of a Public Docket

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-19

    ... docket to obtain input on recommendations for regulations on good manufacturing practice for tobacco... current good manufacturing practice, or hazard analysis and critical control point methodology.'' On... Product Good Manufacturing Practices Regulation and Request for Meeting, submitted to FDA, January...

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

    PubMed

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

    2014-10-21

    We conducted a four-arm, double-blind, randomized controlled trial among 818 Bangladeshi infants between 10 and 12 months of age to establish equivalence among three lots of live attenuated SA 14-14-2 JE vaccine manufactured by the China National Biotec Group's Chengdu Institute of Biological Products (CDIBP) in a new Good Manufacturing Practice (GMP) facility and to evaluate non-inferiority of the product with a lot of the same vaccine manufactured in CDIBP's original facility. The study took place in two sites in Bangladesh, rural Matlab and Mirpur in urban Dhaka. We collected pre-vaccination (Day 0) and post-vaccination Day 28 (-4 to +14 days) blood samples to assess neutralizing anti-JE virus antibody titers in serum by plaque reduction neutralization tests (PRNT). Seroprotection following vaccination was defined as a PRNT titer ≥1:10 at Day 28 in participants non-immune at baseline. Follow-up for reactogenicity and safety was conducted through home visits at Day 7 and monitoring for serious adverse events through Day 28. Seroprotection rates ranged from 80.2% to 86.3% for all four lots of vaccine. Equivalence of the seroprotection rates between pairs of vaccine lots produced in the new GMP facility was satisfied at the pre-specified 10% margin of the 95% confidence interval (CI) for two of the three pairwise comparisons, but not for the third (-4.3% observed difference with 95% CI of -11.9 to 3.3%). Nevertheless, the aggregate seroprotection rate for all three vaccine lots manufactured in the GMP facility was calculated and found to be within the non-inferiority margin (within 10%) to the vaccine lot produced in the original facility. All four lots of vaccine were safe and well tolerated. These study results should facilitate the use of SA 14-14-2 JE vaccine as a routine component of immunization programs in Asian countries. PMID:25239483

  17. 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…

  18. 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.

  19. Practicing Good Habits, Grade 1.

    ERIC Educational Resources Information Center

    Huynh Cong Tu; And Others

    This primer, intended for use during the child's first year in elementary school in Vietnam, relates the story of the daily lives of Hong, age 10, and her brother Lac, age 7, at home and at school. The 64 lessons are divided into four chapters: (1) Good Habits (personal hygiene, grooming, dressing, obedience, truthfulness); (2) At Home: Father and…

  20. Integrating Education: Parekhian Multiculturalism and Good Practice

    ERIC Educational Resources Information Center

    McGlynn, Claire

    2009-01-01

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

  1. 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

  2. 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…

  3. 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.

  4. 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.

  5. 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…

  6. 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…

  7. [New guidelines on good scientific practice].

    PubMed

    Nielsen, Ole Haagen

    2009-05-25

    In 2009 the Danish Committees on Scientific Dishonesty released their new guidelines on good scientific practice (i.e. responsible conduct of research) with a particular focus on healthcare. These guidelines are intended to help Danish researchers avoid any discreditability of their scientific work, and especially to improve the general standard of their research. PMID:19486614

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

    ERIC Educational Resources Information Center

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

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

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

    SciTech Connect

    1998-12-01

    This Guide to Good Practices is written to enhance understanding of, and provide direction for, ``Shift Routines and Operating Practices,`` Chapter 2 of Department of Energy (DOE) Order 5480.19, Conduct of Operations Requirements for DOE Facilities. The practices in this guide should be considered when planning or reviewing shift routines and operating practices. ``Shift Routines and Operating Practices`` is an element of an effective Conduct of Operations program. The complexity and array of activities performed in DOE facilities dictate the necessity for a high standard of professional conduct and sound operating practices to promote safe and efficient operations. Recently, guidance pertaining to this element has been strengthened for nuclear power reactors. This additional guidance is given in Appendix C for information purposes. Though this guidance and good practices pertain to nuclear power reactors, DOE sites may choose to use a graded approach for implementing these in nuclear facilities.

  10. Guide to good practices for independent verification

    SciTech Connect

    1998-12-01

    This Guide to Good Practices is written to enhance understanding of, and provide direction for, Independent Verification, Chapter X of Department of Energy (DOE) Order 5480.19, Conduct of Operations Requirements for DOE Facilities. The practices in this guide should be considered when planning or reviewing independent verification activities. Contractors are advised to adopt procedures that meet the intent of DOE Order 5480.19. Independent Verification is an element of an effective Conduct of Operations program. The complexity and array of activities performed in DOE facilities dictate the necessity for coordinated independent verification activities to promote safe and efficient operations.

  11. Guide to good practices for logkeeping

    SciTech Connect

    1998-12-01

    This Guide to Good Practices is written to enhance understanding of, and provide direction for, Logkeeping, Chapter XI of Department of Energy (DOE) Order 5480.19, Conduct of Operations Requirements for DOE Facilities. The practices in this guide should be considered when planning or reviewing logkeeping programs. Contractors are advised to adopt procedures that meet the intent of DOE Order 5480.19. Logkeeping is an element of an effective Conduct of Operations program. The complexity and array of activities performed in DOE facilities dictate the need for a consistent logkeeping program to promote safe and efficient operations.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 75 FR 80011 - Good Laboratory Practice for Nonclinical Laboratory Studies

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-21

    ..., 1978 (43 FR 60013). As stated in its scope (Sec. 58.1), this regulation prescribes good laboratory..., sponsors have requested the ability to cite compliance with the applicable good manufacturing requirements... be required under a revised part 58, subpart F or the relevant good manufacturing requirements....

  17. 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 ADMINISTRATIVE PRACTICES AND PROCEDURES General Administrative Procedures § 10.115 Good guidance practices. (a) What are good guidance practices? Good...

  18. Prakriti-based research: Good reporting practices.

    PubMed

    Bhalerao, Supriya; Patwardhan, Kishor

    2016-03-01

    The recent advances in the fields of genomics, personalized medicine, and Ayurveda have motivated many researchers to look at the relationship between Prakriti (phenotype-based Ayurveda constitution) and various objective biological parameters. As a result, a number of studies reporting such a relationship have made their way into mainstream scholarly journals. However, when it comes to the protocols that these workers follow to identify one's Prakriti, there are several issues that are yet to be resolved. In this communication, we propose a few reporting practices that such workers are required to be encouraged to follow, while submitting their work on Prakriti to scholarly journals. We have arranged this proposal under the following domains that may serve as a preliminary checklist in this context: The textual references, validation process, assessment of characters, scoring pattern, weightage assignment, criterion for expressing the final Prakriti type, and a need to publish the complete Prakriti-determination tool. We advocate that only if the workers in the field adhere to these good reporting practices, one will be able to draw meaningful, generalizable, and applicable interpretations out of such studies. We also suggest that the editors of relevant scholarly journals may recommend these reporting practices while considering such reports for publication. PMID:27297513

  19. Guide to good practices for continuing training

    SciTech Connect

    Not Available

    1993-02-01

    The purpose of this Guide to Good Practices for Continuing Training is to provide contractor training organizations with information and methods useful in the development and implementation of a continuing training program. DOE Order 5480.18A, ``Accreditation of Performance-Based Training for Category A Reactors and Nuclear Facilities,`` and DOE Order 5480.20, ``Personnel Selection, Qualification and Training Requirements at DOE Reactor and Non-reactor Nuclear Facilities`` Chapter 1, Paragraph 7, require each facility to design and implement a continuing training program. Continuing training is necessary to ensure that facility personnel continually improve their ability to operate and maintain their facility in a safe and reliable manner. Continuing training also should enhance the professionalism of these individuals and should make them aware of the possible consequences of misoperation.

  20. 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.

  1. [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. PMID:15156764

  2. Good practice in multimedia courseware development.

    PubMed

    Schulz, C

    1998-01-01

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

  3. 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…

  4. 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. PMID:8495601

  5. Defense programs beryllium good practice guide

    SciTech Connect

    Herr, M.

    1997-07-01

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

  6. 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. 21 CFR 1271.150 - Current good tissue practice requirements.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Current good tissue practice requirements. 1271... HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS Current Good Tissue Practice § 1271.150 Current good tissue practice requirements. (a) General. This subpart D and subpart C of this part...

  8. 21 CFR 1271.150 - Current good tissue practice requirements.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Current good tissue practice requirements. 1271... HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS Current Good Tissue Practice § 1271.150 Current good tissue practice requirements. (a) General. This subpart D and subpart C of this part...

  9. 21 CFR 1271.150 - Current good tissue practice requirements.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Current good tissue practice requirements. 1271... HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS Current Good Tissue Practice § 1271.150 Current good tissue practice requirements. (a) General. This subpart D and subpart C of this part...

  10. 21 CFR 1271.150 - Current good tissue practice requirements.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

  11. 21 CFR 1271.150 - Current good tissue practice requirements.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Current good tissue practice requirements. 1271... HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS Current Good Tissue Practice § 1271.150 Current good tissue practice requirements. (a) General. This subpart D and subpart C of this part...

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

    PubMed

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

    2014-11-01

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

  13. 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…

  14. 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...

  15. 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...

  16. 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,...

  17. 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. PMID:18060692

  18. 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 RADIO BROADCAST SERVICES Noncommercial Educational FM Broadcast Stations § 73.508 Standards of good engineering practice. (a) All...

  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. 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…

  1. 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)…

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

    PubMed

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

    2016-01-01

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

  3. 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...

  4. 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.

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

    PubMed

    Osorio, Lyda

    2015-06-01

    An increasing number of countries are adopting good clinical practices guidelines as part of the regulation of clinical studies to register pharmaceutical products and other health-related products. Consequently, all parties involved in the research and development of these products should know them, implement them and ensure their compliance. However, good clinical practices guidelines are just one of the initiatives seeking to achieve the highest ethical and scientific standards in health research and in other areas where humans are research subjects. This review defines such practices and their objectives presenting in a practical manner their legal framework in Colombia, and clarifying their application in studies where interventions use no medications or those that are not clinical trials. Finally, the work discusses the challenges to ensure that good clinical practices contribute to the protection of research participants, the education of trustworthy health professionals, and a culture of respect for human beings. PMID:26535550

  6. 47 CFR 73.508 - Standards of good engineering practice.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

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

  7. 47 CFR 73.508 - Standards of good engineering practice.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

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

  8. 47 CFR 73.508 - Standards of good engineering practice.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

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

  9. 47 CFR 73.508 - Standards of good engineering practice.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

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

  10. Sharing Good Practice through Mash-Up Personal Learning Environments

    NASA Astrophysics Data System (ADS)

    Mödritscher, Felix; Wild, Fridolin

    Personal learning environments (PLEs) require new ways to motivate and scaffold learners. In particular, practice sharing is of importance for learnercentric approaches in the scope of (technology-enhanced) lifelong learning, as it is an enabler for community building and sustaining. In this paper we elaborate prerequisites for ‘good practice sharing’ and explain how we realized these aspects in our PLE solution named Mash-Up Personal Learning Environments (MUPPLE.org). Finally, we argue for the utility of our MUPPLE approach by highlighting two different strategies of good practice sharing and their benefits for learning and community building.

  11. 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...

  12. 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...

  13. 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...

  14. 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...

  15. 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...

  16. 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...

  17. 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...

  18. 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...

  19. 40 CFR 59.603 - How must manufacturers apply good engineering judgment?

    Code of Federal Regulations, 2014 CFR

    2014-07-01

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

  20. 40 CFR 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...

  1. 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.

  2. 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.

  3. Guide to good practices for operator aid postings

    SciTech Connect

    Not Available

    1993-06-01

    This Guide to Good Practices is written to enhance understanding of, and provide direction for, Operator Aid Postings, Chapter XVII of Department of Energy (DOE) Order 5480.19, Conduct of Operations Requirements for DOE Facilities.'' The practices in this guide should be considered when planning or reviewing operator aid postings. Contractors are advised to adopt procedures that meet the intent of DOE Order 5480.19.

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

    PubMed

    Tuckett, A

    1999-09-01

    This article reviews the literature on deception to illuminate the phenomenon as a background for an appraisal within nursing. It then describes nursing as a practice of caring. The character of the Good Samaritan is recommended as indicative of the virtue of compassion that ought to underpin caring in nursing practice. Finally, the article concludes that a caring nurse, responding virtuously, acts by being compassionate, for a time recognizing the prima facie nature of the rules or principles of truth telling. PMID:10696185

  5. Robust data enables managers to promote good practice.

    PubMed

    Bassett, Sally; Westmore, Kathryn

    2012-11-01

    This is the third in a series of articles examining the components of good corporate governance. The effective and efficient use of information and sources of information is crucial for good governance. This article explores the ways in which boards and management can obtain and use information to monitor performance and promote good practice, and how boards can be assured about the quality of information on which they rely. The final article in this series will look at the role of accountability in corporate governance. PMID:23189532

  6. Seven Principles for Good Practice in Distance Learning.

    ERIC Educational Resources Information Center

    Tulloch, Jacquelyn

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

  7. 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... office level or if you feel that you are not making progress by going through the chain of command,...

  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,...

  9. 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,...

  10. 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,...

  11. Successful Tutoring: Good Practice for Managers and Tutors.

    ERIC Educational Resources Information Center

    Green, Muriel

    This document, which draws on the findings of a survey of further education (FE) colleges in the United Kingdom and case studies of 9 FE colleges, presents good practices for managers of tutoring programs and tutors. Chapter 1 provides an overview of the changing role of tutors in the post-16 sector and the importance of recruiting, training, and…

  12. 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.…

  13. 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…

  14. 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…

  15. Implementing HR Strategies: A Guide to Good Practice.

    ERIC Educational Resources Information Center

    Higher Education Funding Council for England, Bristol.

    This guide aims to help institutions of higher education in England develop and implement their human resources (HR) strategies. It provides advice and examples of good practice in key areas, in response to requests from institutions. The report supplements earlier guidance on developing HR strategies (March 2002) and presents information for…

  16. 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.

  17. DEVELOPMENT OF GOOD COMBUSTION PRACTICE FOR MUNICIPAL WASTE COMBUSTORS

    EPA Science Inventory

    The paper summarizes the rationale for EPA's good combustion practice (GCP) strategy. OTE: The EPA is developing new air pollution rules for all new and existing municipal waste combustors (MWCs), rules requiring all MWCs to use GCP. The goals of GCP are to maximize furnace destr...

  18. 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…

  19. 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…

  20. 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…

  1. 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…

  2. 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…

  3. 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.

  4. 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…

  5. 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...

  6. 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.

  7. 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. PMID:21979432

  8. 75 FR 73101 - Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-29

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

  9. 78 FR 17215 - Agency Information Collection Activities: Proposed Collection; Comment Request; Current Good...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-20

    ... Collection; Comment Request; Current Good Manufacturing Practice for Positron Emission Tomography Drugs... regulations on current good manufacturing practice (CGMP) for positron emission tomography (PET) drugs. DATES... of information technology. Current Good Manufacturing Practice for Positron Emission Tomography...

  10. 76 FR 45262 - Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-28

    ... Collection; Comment Request; Current Good Manufacturing Practices and Related Regulations for Blood and Blood... current good manufacturing practice (CGMP) and related regulations for blood and blood components; and... of information technology. Current Good Manufacturing Practices and Related Regulations for Blood...

  11. A model for reflection for good clinical practice.

    PubMed

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

    2009-12-01

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

  12. 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.

  13. [Good practice for medical surveillance by occupational physicians].

    PubMed

    Roscelli, F; Frigeri, G; Quercia, A; De Rosa, A

    2006-01-01

    Society--employers, workers, trade unions, public--demands the highest standards of professional competence and ethical conduct from occupational physicians. However, defining what exactly constitutes good medical practice and acceptable standards of professional competence and conduct is not so easily done. Good practice in occupational medicine should be aimed not only at improving the effectiveness of preventive action in the strict sense, but also at constantly adopting rigorous methodologies based on evidence and procedures breaking loose from rigid formats, which must be as uniform as possible throughout the country. It's essential, therefore, to develop consensus documents on workers' health surveillance, meeting with approval of occupational health physicians both operating in a free market context or within the framework of public sector health service. PMID:17144422

  14. 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.

  15. 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.

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

    PubMed

    Gillon, Raanan

    2015-01-01

    This paper argues that the four prima facie principles-beneficence, non-maleficence, respect for autonomy and justice-afford a good and widely acceptable basis for 'doing good medical ethics'. It confronts objections that the approach is simplistic, incompatible with a virtue-based approach to medicine, that it requires respect for autonomy always to have priority when the principles clash at the expense of clinical obligations to benefit patients and global justice. It agrees that the approach does not provide universalisable methods either for resolving such moral dilemmas arising from conflict between the principles or their derivatives, or universalisable methods for resolving disagreements about the scope of these principles-long acknowledged lacunae but arguably to be found, in practice, with all other approaches to medical ethics. The value of the approach, when properly understood, is to provide a universalisable though prima facie set of moral commitments which all doctors can accept, a basic moral language and a basic moral analytic framework. These can underpin an intercultural 'moral mission statement' for the goals and practice of medicine. PMID:25516950

  17. 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.

  18. 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.

  19. Holding children and young people: defining skills for good practice.

    PubMed

    Page, Andrea; McDonnell, Andrew

    Physical holds are used to help children and young people receive clinical care in situations where their behaviour may limit the ability of nurses and allied professionals to deliver treatment effectively. This article provides an overview of a qualitative study of 11 nurses and allied professionals who were interviewed with semi-structured questions. The major findings suggest there is a lack of clear and agreed terminology and nurses and allied professionals are guessing at how to describe the practice. As a result, there was no discussion or documentation of the practices of holding (whether successful or unsuccessful) within the clinical area. For the last decade, professional opinion was that this is an 'uncontested practice'. It can therefore be questioned whether this practice has moved from being 'uncontested' to 'indifferent'. Nurses and allied professionals need to revive a common definition of 'good' around the actions of holding, which can hopefully lead to holding skills being more clearly defined and evidence-based. PMID:24225549

  20. Good practices in migrant health: the European experience.

    PubMed

    Mladovsky, Philipa; Ingleby, David; McKee, Martin; Rechel, Bernd

    2012-06-01

    Migrants comprise a growing proportion of European populations. Although many are healthy, those who do need healthcare often face barriers and the care they receive may be inappropriate to their needs. This paper summarises good practices identified in a review of health services for migrants in Europe. Governments should ensure that migrants are entitled to health services, that the services are appropriate to their needs and that data systems are in place to monitor utilisation and detect inequities. Health services should adopt a 'whole organisation approach', in which cultural competence is viewed as much as a task for organisations as for individuals. Health workers should take steps to overcome language, social and cultural barriers to care. In each case, existing examples of good practice are provided. At a time when support is growing in some countries for political parties pursuing anti-immigrant agendas and governments in all countries are pursuing austerity policies, there is a greater need than ever for the public health community to ensure that migrants have access to services that are effective and responsive to their needs. PMID:22783777

  1. 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.

  2. Validation of good agricultural practices (GAP) on Minnesota vegetable farms.

    PubMed

    Hamilton, Karin E; Umber, Jamie; Hultberg, Annalisa; Tong, Cindy; Schermann, Michele; Diez-Gonzalez, Francisco; Bender, Jeff B

    2015-02-01

    The United States Food and Drug Administration and the Department of Agriculture jointly published the "Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables," which is used as a basis for Good Agricultural Practices (GAP) audits. To understand barriers to incorporation of GAP by Minnesota vegetable farmers, a mail survey completed in 2008 was validated with visits to a subset of the farms. This was done to determine the extent to which actual practices matched perceived practices. Two hundred forty-six producers completed the mail survey, and 27 participated in the on-farm survey. Over 75% of the on-farm survey respondents produced vegetables on 10 acres or less and had 10 or fewer employees. Of 14 questions, excellent agreement between on-farm interviews and mail survey responses was observed on two questions, four questions had poor or slight agreement, and eight questions had no agreement. Ninety-two percent of respondents by mail said "they took measures to keep animals and pests out of packing and storage buildings." However, with the on-site visit only 45% met this requirement. Similarly, 81% of respondents by mail said "measures were taken to reduce the risk of wild and/or domestic animals entering into fruit and vegetable growing areas." With direct observation, 70% of farms actually had taken measures to keep animals out of the growing areas. Additional, on-farm assessments were done regarding employee hygiene, training, presence of animals, water sources, and composting practices. This validation study demonstrated the challenge of creating nonleading and concise questions that are not open to broad interpretation from the respondents. If mail surveys are used to assess GAP, they should include open-ended questions and ranking systems to better assess farm practices. To provide the most accurate survey data for educational purposes or GAP audits, on-farm visits are recommended. PMID:25564923

  3. 75 FR 16345 - Administrative Practices and Procedures; Good Guidance Practices; Technical Amendment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-01

    ... 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 Drug Administration, HHS. ACTION: Final rule; technical amendment. SUMMARY: The Food and Drug Administration (FDA)...

  4. 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. PMID:16936621

  5. 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.

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

    PubMed

    Bartlett, Maggie; Potts, Jessica; McKinley, Bob

    2016-07-01

    Keele medical students spend 113 days in general practices over our five-year programme. We collect practice data thought to indicate good quality teaching. We explored the relationships between these data and two outcomes for students; Objective Structured Clinical Examination (OSCE) scores and feedback regarding the placements. Though both are surrogate markers of good teaching, they are widely used. We collated practice and outcome data for one academic year. Two separate statistical analyses were carried out: (1) to determine how much of the variation seen in the OSCE scores was due to the effect of the practice and how much to the individual student. (2) to identify practice characteristics with a relationship to student feedback scores. (1) OSCE performance: 268 students in 90 practices: six quality indicators independently influenced the OSCE score, though without linear relationships and not to statistical significance. (2) Student satisfaction: 144 students in 69 practices: student feedback scores are not influenced by practice characteristics. The relationships between the quality indicators we collect for practices and outcomes for students are not clear. It may be that neither the quality indicators nor the outcome measures are reliable enough to inform decisions about practices' suitability for teaching. PMID:27117344

  7. A European code of good practice for hyperbaric oxygen therapy.

    PubMed

    Kot, Jacek; Desola, Jordi; Simao, Antonio Gata; Gough-Allen, Roly; Houman, Robert; Meliet, Jean-Luis; Galland, Francois; Mortensen, Christian; Mueller, Peter H J; Sippinen, Seppo

    2004-01-01

    In 2001 the Working Group (WG) "Safety" was created within the European COST Action B14 "Hyperbaric Oxygen Therapy" with the main objectives to elaborate recommendations of good practice for hyperbaric medicine and to follow the European normalisation process of hyperbaric chambers. During three years of preparation of the European Code of Good Practice (ECGP) for HBO, the relevant documents concerning safety in hyperbaric chambers from each European country have been revised. The initial document drew on the BHA "Health and Safety for Therapeutic Hyperbaric Facilities: A Code-of Practice" (2000), and later on it was modified using national regulations and standards (from Belgium, Finland, France, Germany, Greece, Italy, Portugal, and Spain), as well as European Norms and existing experience from experts of hyperbaric centres, committees, professional and scientific associations. The ECGP for HBO consists of chapters dedicated to staffing (including responsibilities, competencies and education, minimum team during hyperbaric sessions, fitness and health surveillance), equipment, gas supply, risk management and procedures (including standard and emergency operating procedures, maintenance, record keeping, and patient safety). It also includes ECHM Educational and Training Standards for the Staff of Hyperbaric Centres (1997), ECHM Recommendation for Safety in Multiplace Medical Hyperbaric Chambers (1998), as well as COST B14 Working Group "Technical Aspects" Final Report (2001) including a risk analysis conducted specifically for therapeutic hyperbaric facilities. Many efforts have been spent to make the ECGP for HBO compatible with the new project of the European Norm prEN 14931 "Pressure vessels for human occupancy (PVHO)--Multiplace pressure chamber system for hyperbaric therapy--Performance, safety requirements and testing", which has been prepared at the same time by the CEN/BT/TF 127. Both groups (CEN/BT/TF 127 and COST B14 WG "Safety") cooperated extensively

  8. 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.

  9. [Procedural guidelines. Good tissue practice for cornea banks].

    PubMed

    Schroeter, J; Maier, P; Bednarz, J; Blüthner, K; Quenzel, M; Pruss, A; Reinhard, T

    2009-03-01

    A cornea bank must have an organizational structure in which responsibility and authority to issue directives are clearly defined. It must also use a documented quality management system on the basis of good practice procedures which is maintained to the current standards. The personnel of a cornea bank must be present in sufficient numbers and be suitably qualified. A cornea bank must be in possession of appropriate facilities which are suitable for the main purpose of conservation of donor corneas. All equipment must be designed and maintained corresponding to the intended purpose. Deviations from the stipulated quality and safety standards must give rise to documented investigations which include decisions on options for correctional and preventive measures. Acquisition of donors and tissue sampling must be strictly controlled and documented. This also applies to entry of donor tissue in the cornea bank. During conservation a microscopic examination of the endothelial cell layer must be carried out at least once. Measures must be taken to keep the risk of contamination as low as possible. Donor corneal tissue can only be released if defined criteria are fulfilled. Any suspicion of severe undesired reactions and events for the recipient of a corneal transplant must be registered with the authorities. The activities of a cornea bank must maintain and adapt the state-of-the-art with respect to scientific progress. PMID:19263054

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

    PubMed

    Xie, Yan-Ming; Tian, Feng

    2013-09-01

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

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

    PubMed

    Kellerman, R

    1990-09-01

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

  12. 75 FR 78715 - Small Entity Compliance Guide: Current Good Manufacturing Practice in Manufacturing, Packaging...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-16

    ... rule published in the Federal Register of June 25, 2007, and is intended to set forth in plain language..., 301-436-1440. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of June 25, 2007 (72 FR... Federal Register (72 FR 34959), FDA also issued an interim final rule (the identity testing interim...

  13. 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

    ..., FDA, in the Federal Register of August 3, 1993 (58 FR 41348), amended the packaging and labeling... packaging equipment.'' As noted in the proposed rule (62 FR 40489 at 40491), this additional control... . SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of July 29, 1997 (62 FR 40489) (the...

  14. 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

  15. 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…

  16. 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…

  17. 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

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

    ERIC Educational Resources Information Center

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

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

  19. Stem Cell Therapy for Corneal Epithelium Regeneration following Good Manufacturing and Clinical Procedures

    PubMed Central

    Ramírez, Beatriz E.; Sánchez, Ana; Herreras, José M.; Fernández, Itziar; García-Sancho, Javier; Nieto-Miguel, Teresa; Calonge, Margarita

    2015-01-01

    Objective. To evaluate outcomes of cultivated limbal epithelial transplantation (CLET) for management of ocular surface failure due to limbal stem cell deficiency (LSCD). Design. Prospective, noncomparative, interventional case series and extensive comparison with recent similar studies. Participants. Twenty eyes with LSCD underwent CLET (11 autologous; 9 allogeneic) and were followed up for 3 years. Etiologies were divided into 3 prognostic categories: Group 1, chemical injuries (7 eyes); Group 2, immune-based inflammation (4 eyes); and Group 3, noninflammatory diseases (9 eyes). Intervention. Autologous and allogeneic limbal epithelial cells were cultivated on amniotic membranes and transplanted. Evaluations were based on clinical parameters, survival analysis, and in vivo confocal microscopy (IVCM). European Union Tissues/Cells Directive and good manufacturing procedures were followed. Main Outcome Measures. Improved clinical parameters, absence of epithelial defects, and improved central corneal epithelial phenotype. Results. Success rate was 80% at 1-2 years and 75% at 3 years. Autografts and allografts had similar survival. Success rate was significantly lower in prognostic Group 1 (42.9%) than in Groups 2-3 (100% each). All clinical parameters improved substantially. By IVCM, 80% of cases improved in epithelial status. Conclusions. CLET improved corneal epithelium quality, with subsequent improvement in symptoms, quality of life, and vision. These results confirm that CLET is a valid therapy for ocular surface failure. PMID:26451369

  20. 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. PMID:22591464

  1. 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

  2. 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…

  3. Good Practices in Model-Informed Drug Discovery and Development: Practice, Application, and Documentation.

    PubMed

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

    2016-03-01

    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

  4. 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…

  5. Budget Theory and Budget Practice: How Good the Fit?

    ERIC Educational Resources Information Center

    Rubin, Irene S.

    1990-01-01

    Describes the past and present and projects the future of the relationship between theory and practice for normative and descriptive budget theory. Considers the present and future of normative theory gloomy because budgeting has changed and traditional reform ideas have outlived their usefulness. States that descriptive theory has improved and…

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

    PubMed

    Hills, Laura

    2013-01-01

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

  7. 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...

  8. 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...

  9. 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...

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

    PubMed

    Grainger, Angela

    2010-07-01

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

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

    Technology Transfer Automated Retrieval System (TEKTRAN)

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

  12. 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

    ... amount or redistribute budgeted funds, as appropriate, by at least the differential established in 2 CFR... 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...

  13. 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

    ... appropriate, by at least the differential established in 2 CFR 176.110(a). (3) Unless the Federal Government... 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...

  14. 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

    ... amount or redistribute budgeted funds, as appropriate, by at least the differential established in 2 CFR... 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...

  15. 2 CFR 176.170 - Notice of Required Use of American Iron, Steel, and Manufactured Goods (covered under...

    Code of Federal Regulations, 2011 CFR

    2011-01-01

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

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

    PubMed

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

    2016-06-01

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

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

    PubMed

    Mattingly, C

    1998-09-01

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

  18. 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

  19. 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

  20. Overcoming the effects of acute stress through good teamwork practices

    SciTech Connect

    Harrington, D.K. ); Gaddy, C.D. )

    1992-01-01

    Two recent industry studies have taken a look at operators in stressful situations. In the context of severe-accident management, Mumaw et al. discussed four approaches to training operators for severe accidents: (1) training for knowledge or procedural skills; (2) training decision makers about goals and plans; (3) training to avoid cognitive biases; and (4) training within a realistic setting. These four approaches address directly the cognitive skills important for decision making. These types of training can also address indirectly the effects of stress on performance. First, effects of stress on decision making, such as reduced working memory, can be addressed by training cognitive skills. Second, exposure to realistically stressful situations can reduce the novelty and uncertainty, which is a primary cause of stress reactions. In a second study reported by Desaulniers, the stress of requalification exams was the focus. Desaulniers concluded that repeated changes in the exam process, inconsistency in interpretation of examiner guidelines, and some content and grading practices resulted in undue stress for the operators. The US Nuclear Regulatory Commission staff actions to remedy these sources of undue stress were described.

  1. Think INN, prescribe INN, dispense INN: good professional practice.

    PubMed

    2000-12-01

    (1) International nonproprietary names (INN) for drugs were invented about fifty years ago, under the aegis of the World Health Organisation, to provide a common language for health professionals and patients worldwide. (2) No country forbids INN prescriptions. Some countries actively recommend using INNs. (3) INN prescription empowers prescribers and pharmacists in their choice of treatment. (4) The choice between a prescription based on the INN or the brand name will depend on the type of treatment (short term or chronic), the nature of the drug (especially its therapeutic margin) and any specific risks related to the patient (age, disease condition, allergy, and adherence). (5) A pharmacist's decision to dispense a brand name drug from an INN prescription must be based on usual dispensing precautions. (6) Adopting INN prescribing means having to reflect on one's knowledge of drugs, and to challenge the quality of one's initial and continuing education in pharmacology and therapeutics. The INN system is a means of improving prescribing and dispensing practices: it involves paying more attention to the patient, explaining the treatment in greater detail, and respecting his/her choice. PMID:11475502

  2. De praeceptis ferendis: good practice in multi-model ensembles

    NASA Astrophysics Data System (ADS)

    Kioutsioukis, I.; Galmarini, S.

    2014-06-01

    Ensembles of air quality models have been formally and empirically shown to outperform single models in many cases. Evidence suggests that ensemble error is reduced when the members form a diverse and accurate ensemble. Diversity and accuracy are hence two factors that should be taken care of while designing ensembles in order for them to provide better predictions. There exists a trade-off between diversity and accuracy for which one cannot be gained without expenses of the other. Theoretical aspects like the bias-variance-covariance decomposition and the accuracy-diversity decomposition are linked together and support the importance of creating ensemble that incorporates both the elements. Hence, the common practice of unconditional averaging of models without prior manipulation limits the advantages of ensemble averaging. We demonstrate the importance of ensemble accuracy and diversity through an inter-comparison of ensemble products for which a sound mathematical framework exists, and provide specific recommendations for model selection and weighting for multi model ensembles. To this end we have devised statistical tools that can be used for diagnostic evaluation of ensemble modelling products, complementing existing operational methods.

  3. 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…

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

    ERIC Educational Resources Information Center

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

    2012-01-01

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

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

    PubMed

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

    2014-01-01

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

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

    PubMed

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

    2012-01-01

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

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

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 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 52.225-24 - 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...

  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...

  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...