Prequalification of QC laboratories

The World health Organization (WHO) has released a new working document on how quality control laboratories qualify, in relation to GMP, for use by the United Nations.

The introduction reads:

“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:

– 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.

The document can be viewed here.

Posted by Dr. Tim Sandle