Prequalification of quality control laboratories: procedure for assessing the acceptability, in principle, of quality control laboratories for use by United Nations agencies
Introduction:
This document provides an update of the procedure originally published as Annex 12 in World Health Organization (WHO) Technical Report Series, No. 961, 2011. WHO provides United Nations (UN) agencies, their partners, procurement agencies serving national authorities and UN agencies and/or national authorities of WHO Member States, on request, with advice on the acceptability, in principle, of quality control laboratories (QCLs) that are found to meet WHO-recommended quality standards for such laboratories. These standards are set out in Good practices for pharmaceutical quality control laboratories (GPCL) (1), and include, where applicable, good practices for pharmaceutical microbiology laboratories (2) and the relevant parts of good manufacturing practices (GMP) (3). This is done through a standardized quality assessment procedure. The purpose of the quality assessment procedure is to evaluate whether the QCLs to be used for the quality control of pharmaceutical products meet the requirements recommended by WHO for such laboratories.
Participation in the prequalification procedure is voluntary and any pharmaceutical QCL (governmental or private) providing quality control services for pharmaceutical products to UN agencies, their partners, procurement agencies serving national authorities and UN agencies and/or national authorities of WHO Member States is eligible.
Accreditation, such as ISO (in terms of ISO/IEC17025), is encouraged and will also be considered in the prequalification procedure. Laboratories are recommended to work towards obtaining accreditation.
The quality assessment procedure established by WHO is based on the following principles:
– evidence that the laboratory provides or is committed to offering quality control services for pharmaceutical products to UN agencies and their partners, procurement agencies serving national authorities and UN agencies and/or national authorities of WHO Member States;
– a general understanding of the documented quality assurance management and quality control testing activities of the laboratory;
– evaluation of information submitted by the laboratory;
– assessment of compliance with WHO-recommended quality standards for QCLs, i.e. GPCL (1), including, where applicable, good practices for pharmaceutical microbiology laboratories (2) and the relevant parts of GMP (3);
– monitoring of performance of prequalified laboratories.
WHO invites the national medicines regulatory authority (NMRA), having regulatory oversight over a laboratory participating in the prequalification procedure, to join as an observer in the inspection of the laboratory’s compliance with WHO-recommended standards for QCLs. WHO recommends that laboratories expressing an interest in participating in the prequalification procedure inform the regulatory authority of the country in which they are established as well as relevant networks (e.g. the official medicines control laboratories network) of their submission for prequalification.
This procedure is to be followed for prequalification of QCLs for use by UN agencies and their partners, procurement agencies serving national authorities and UN agencies and/or national authorities of WHO Member States.
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Table of Contents
1.1 Publication of
invitation for Expressions of Interest
1.2 Submission of EOIs
and laboratory information
1.3 Screening of
submitted laboratory information
1.4 Evaluation of the
laboratory information
1.6 Report and outcome
of inspection
1.8 Monitoring of
prequalified QCLs
WHO TRS (Technical Report Series) 1003, 2017 Annex 3:
