8 General guidelines for the establishment maintenance and distribution of

8 general guidelines for the establishment

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8. General guidelines for the establishment, maintenance and distribution of chemical reference substances. In: WHO Expert Committee on Specifications for Pharmaceutical Preparations. Forty-first 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:1995) 2008 (ISO/IEC Guide 98-3).
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122 11. Supplementary guidelines in good manufacturing practice: validation. Qualification of systems and equipment. In: WHO Expert Committee on Specifications 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 Specifications 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: — see background: 16. Computerised systems. In: The rules governing medicinal products in the European Union . Vol. 4. Good manufacturing practice (GMP) guidelines . Annex 11 ( pdfs-en/anx11en.pdf). 17. Official Medicines Control Laboratories Network of the Council of Europe, Quality Assurance Documents: PA/PH/OMCL (08) 69 3R — Validation of computerised systems — core document ( Validation_of_Computerised_Systems_Core_Documentpdf-en-8390-2.html) and its annexes: PA/PH/OMCL (08) 87 2R — Annex 1: Validation of computerised calculation systems: example of validation of in-house software ( calculationpdf-en-8391-2.html), PA/PH/OMCL (08) 88 R — Annex 2: Validation of Databases (DB), Laboratory Information Management Systems (LIMS) and Electronic Laboratory Notebooks (ELN) ( Validation_of_Databases_DB_Laboratory_pdf-en-8392-2.html), PA/PH/OMCL (08) 89 R — Annex 3: Validation of computers as part of test equipment ( of_computers_as_part_of_tespdf-en-8393-2.html).
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