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WHO good practices for pharmaceutical quality control laboratories
General considerations:
The WHO Expert Committee on Specifications for Pharmaceutical Products adopted in 1999 the guidelines entitled WHO Good practices for national pharmaceutical control laboratories, which were published as Annex 3 of the WHO Technical Report Series, No. 902, 2002. As the other guidelines related to laboratory quality assurance have been updated and subsequent inspections for the compliance with the guidelines on good practices for national pharmaceutical control laboratories indicated that some sections were in need of improvement and clarification, it was considered necessary to prepare a revised text.
These guidelines provide advice on the quality management system within which the analysis of active pharmaceutical ingredients (APIs), excipients and pharmaceutical products should be performed to demonstrate that reliable results are obtained.
Compliance with the recommendations provided in these guidelines will help promote international harmonization of laboratory practices and will facilitate cooperation among laboratories and mutual recognition of results.
Special attention should be given to ensure the correct and efficient functioning of the laboratory. Planning and future budgets should ensure that the necessary resources are available inter alia for the maintenance of the laboratory, as well as for an appropriate infrastructure and energy supply. Means and procedures should be in place (in case of possible supply problems) to ensure that the laboratory can continue its activities.
These guidelines are applicable to any pharmaceutical quality control laboratory, be it national, commercial or nongovernmental. However, they do not include guidance for those laboratories involved in the testing of biological products, e.g. vaccines and blood products. Separate guidance for such laboratories is available.
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Table of contents
Part one. Management and
infrastructure
1. Organization and
management
8. Equipment,
instruments and other devices
Part two. Materials,
equipment, instruments and other devices
11. Reference substances
and reference materials
Part three. Working
procedures
16. Validation of
analytical procedures
18. Evaluation of test
results
Appendix: Equipment for a first-stage and medium-sized pharmaceutical quality control laboratory
WHO TRS (Technical Report Series) 957, 2010 Annex 1:
