81 World Health Organization who technical Report Series, No. 957, 2010



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pharmaceutical analysis
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

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