8 general guidelines for the establishment

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).

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).