WHO TRS (Technical Report Series) 943 Annex 5

Prequalification of quality control laboratories. Procedure for assessing the acceptability, in principle, of quality control laboratories for use by United Nations agencies

Introduction:

The World Health Organization (WHO) provides United Nations agencies, on request, with advice on the acceptability, in principle, of quality control laboratories that are found to meet WHO recommended quality standards, i.e. Good Practices for National Pharmaceutical Control Laboratories (1) and good manufacturing practices (GMP) as recommended by WHO (2), for such laboratories. This is done through a standardized quality assessment procedure. The purpose of the quality assessment procedure is to evaluate whether the quality control laboratories to be used for the analysis of pharmaceutical products meet the requirements recommended by WHO for such laboratories. 

Participation in the prequalification procedure is voluntary and any laboratory (private or governmental) could participate. Certification such as ISO (in terms of ISO/IEC17025) is encouraged and will also be considered in the prequalification procedure. It is recommended that laboratories should work towards obtaining certification. 

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WHO TRS (Technical Report Series) 943 Annex 5: