81 World Health Organization who technical Report Series, No. 957, 2010
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| References 1. Quality assurance of pharmaceuticals. A compendium of guidelines and related materials. Vol. 2, 2nd updated edition. Good manufacturing practices and inspection. Geneva, World Health Organization, 2007. 2. International Organization for Standardization. General requirements for the competence of testing and calibration laboratories. ISO/IEC 17025:2005. 3. Model certifi cate of analysis. In WHO Expert Committee on Specifi cations for Pharmaceutical Preparations. Thirty-sixth report. Geneva, World Health Organization, 2002, Annex 10 (WHO Technical Report Series, No. 902). 4. International vocabulary of metrology — Basic and general concepts and associated terms. VIM rd ed., Joint Committee for Guides in Metrology (JCGM) 200:2008 (http://www.bipm.org/utils/common/documents/jcgm/ JCGM_200_2008.pdf). 5. Guidance for industry — Investigating out-of-specifi cation test results for pharmaceutical production. US Food and Drug Administration, Center for Drug Evaluation and Research (CDER), October 2006 (http://www.fda.gov/ downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ UCM070287.pdf). 6. Guidelines for inspection of drug distribution channels. In WHO Expert Committee on Specifi cations for Pharmaceutical Preparations. Thirty fth report. Geneva, World Health Organization, 1999, Annex 6 (WHO Technical Report Series, No. 885). 7. Good manufacturing practices supplementary guidelines for the manufacture of pharmaceutical excipients. In WHO Expert Committee on Specifi cations for Pharmaceutical Preparations. Thirty fth report. Geneva, World Health Organization, 1999, Annex 5 (WHO Technical Report Series, No. 885). 8. General guidelines for the establishment, maintenance and distribution of chemical reference substances. In WHO Expert Committee on Specifi cations for Pharmaceutical Preparations. Forty rst report. Geneva, World Health Organization, 2007, Annex 3 (WHO Technical Report Series, No. 943). 9. International Organization for Standardization. Guidance for the use of repeatability, reproducibility and trueness estimates in measurement uncertainty estimation. 2004 (ISO Guide 21748). 10. International Organization for Standardization/International Electrotechnical Commission. Uncertainty of measurement — Part 3: Guide to the expression of uncertainty in measurement (GUM) 2008 (ISO/IEC Guide 98-3). TRS957.indd 121 21.04.10 11:03 122 11. Supplementary guidelines in good manufacturing practice validation. Qualifi cation of systems and equipment. In WHO Expert Committee on Specifi cations for Pharmaceutical Preparations. Fortieth report. Geneva, World Health Organization, 2006, Annex 4, Appendix 6 (WHO Technical Report Series, No. 937). 12. Supplementary guidelines in good manufacturing practice validation. Validation of computerized systems. In WHO Expert Committee on Specifi cations for Pharmaceutical Preparations. Fortieth report. Geneva, World Health Organization, 2006, Annex 4, Appendix 5 (WHO Technical Report Series, No. 937). 13. Good automated manufacturing practice (GAMP) Good Practice Guides: Validation of laboratory computerized systems. International Society for Pharmaceutical Engineering (ISPE), 2005. 14. Good automated manufacturing practice (GAMP) Good Practice Guides Electronic data archiving. International Society for Pharmaceutical Engineering (ISPE),2007. 15. Title 21 Code of Federal Regulations (21 CFR Part 11): Electronic records electronic signatures. US Food and Drug Administration. The current status of 21 CFR Part 11 Guidance is located under Regulations and Guidance at http://www.fda.gov/cder/gmp/index.htm — see background http://www.fda.gov/OHRMS/DOCKETS/98fr/03-4312.pdf 16. Computerised systems. In The rules governing medicinal products in the Download 176.21 Kb. Share with your friends:
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