WHO TRS (Technical Report Series) 917 Annex 4

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

1. Introduction:

The World Health Organization (WHO) could provide United Nations agencies with advice on the acceptability, in principle, of quality control laboratories that are found to meet WHO recommended quality standards, for use by such agencies. This will be done through a standardized quality assessment procedure. The purpose of the quality assessment procedure is to evaluate whether quality control laboratories meet the requirements recommended by WHO for such laboratories to be used for the analysis of pharmaceutical products purchased as part of the pre-qualification procedure for products including, but not limited to, those for the treatment of HIV/AIDS, tuberculosis (TB) and malaria. Participation in the pre-qualification 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.

The quality assessment procedure established by WHO is based on the following principles:

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WHO TRS (Technical Report Series) 917 Annex 4: