With the recent update of the WHO Guidelines on Good Practices for Pharmaceutical Quality Control Laboratories, the WHO has decided to revise two guidelines on this matter too. These have now been published in the WHO Technical Report Series, No. 961, 2011:
Prequalification of quality control laboratories. Procedures for assessing the acceptability, in principle, of quality control laboratories for use by United Nations agencies (Annex 12, pages 393 - 402)
WHO Guidelines for preparing laboratory information file (Annex 13, pages 403 - 408)
Upon request, the WHO provides the United Nations information about which QC Laboratories comply with the standard required, i.e. with the Good Practices for Pharmaceutical Quality Control Laboratories (GPCL) and the relevant parts of GMP. This is enabled through a standardised quality assessment procedure.
The participation in Annex 12 Prequalification Procedure is voluntary. Any pharmaceutical quality control laboratory (whether governmental or private) can participate. In this case, ISO 17025 certification is recommended. Beside the evaluation of the information submitted, the WHO may also carry out an inspection of the laboratory.
In the WHO Guideline on Preparing a Laboratory Information File, you can find requirements about what information regarding the laboratory is needed. The most important pieces of information a laboratory must provide are listed in 13 sections.
Dr Günter Brendelberger
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)