WHO Technical Report Series, No. 981 - World Health Organization

11. Prequalification of quality control laboratories
11.1 Update on the prequalification of quality control laboratories
The prequalification procedure for quality control laboratories (QCLs) was
originally established in 2004 for Africa only and has since expanded globally.
Any QCL (whether public or private) may now participate in the programme.
Participation is voluntary and 55 laboratories have asked to participate since 2004
(73% being national QCLs). The Expert Committee heard that 24 laboratories are
currently prequalified, with at least one in each WHO region. The programme
also includes capacity-building, with training and technical assistance provided
for national QCLs in developing countries.
An informal network of QCLs, which have been prequalified, have
submitted an application for prequalification or have actively participated in
prequalification testing projects or other activities, is currently being set up in
cooperation with a WHO collaborating centre in South Africa. The objectives
are to support the quality of laboratory testing within the network, to facilitate
reliable testing of medicines procured by United Nations agencies, and to facilitate
information exchange, networking and work-sharing.
The benefits to QCLs of prequalification include the possibility to provide
testing services to United Nations agencies and other organizations, the recognition
that comes of being listed as a WHO-prequalified laboratory, the learning process
of improving laboratory standards, and the possibility of being assisted by WHO
expert consultants and of participating in WHO-organized training. The Expert
Committee heard that countries appreciate having prequalified laboratories in
their own region for the convenience and speed of service that these laboratories
provide.
The Expert Committee expressed its appreciation for the report.
WHO Technical Report Series, No. 981, 2013
11.2 Update on WHO quality monitoring projects
PQP organizes quality monitoring of medicines projects to monitor the quality
of prequalified products and of medicines procured by United Nations agencies.
It was noted that this contributes to the quality control of medicines in Member
States and to capacity-building through cooperation with NMRAs. The Expert
Committee heard that, in response to a complaint of poor quality, a survey of the
quality of antimalarials supplied within phase 1 of the Affordable Medicines Facility
malaria project (AMFm), which is managed by GFATM, is being conducted. The
evaluation will cover both the product itself and the storage conditions.
The Expert Committee expressed its appreciation for the report.
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