Prequalification of Quality Control Laboratories. Procedure for Assessing the Acceptability, in Principle, of Quality Control Laboratories for Use by United Nations Agencies. WHO Technical Report Series, No. 961, 2011, Annex 12
(2011; 10 pages) [French]

Resumen

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 for such laboratories, i.e. Good practices for pharmaceutical quality control laboratories (GPCL) and the relevant parts of good manufacturing practices (GMP). 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 quality control of pharmaceutical products meet the requirements recommended by WHO for such laboratories.

Participation in the prequalification procedure is voluntary and any pharmaceutical quality control laboratory (governmental or private) 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:

  • commitment of the laboratory to providing services of testing of pharmaceutical products to United Nations agencies;
  • a general understanding of the 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 quality control laboratories, i.e. GPCL and the relevant parts of GMP; and
  • 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 quality control laboratories. 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 (OMCL) network) of their submission for prequalification. This procedure is to be followed for prequalification of quality control laboratories for use by the United Nations agencies.

 
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