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 for such laboratories, i.e. Good practices for pharmaceutical quality control laboratories (GPCL) (1) and the relevant parts of good manufacturing practices (GMP) (2). 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 (1) and the relevant parts of GMP (2); and
- monitoring of performance of prequalified laboratories.
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Table of contents
1.1 Publication of
invitation for Expressions of Interest
1.2 Submission of
Expressions of Interest 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 quality control laboratories
1.9 Monitoring of
complaint(s)
WHO TRS (Technical Report Series) 961, 2011 Annex 12:
