Prequalification of quality control laboratories

The Secretariat informed the Committee of the progress made in this area. To date 15 laboratories had expressed an interest in being assessed under this new procedure. Eight laboratories had so far been inspected and two had been listed as prequalified. 

A proposal to amend the procedure, to make provision for the review of a Quahty Manual (in place of a Laboratory Information File (LIF)) and to include an inventory audit was discussed. The Committee agreed that the proposed amended procedure be presented to the WHO Legal Counsel for comments before finalization. 

The Committee was informed that there had been a move towards the prequalification of manufacturers of APIs. The focus so far had been on ARVs, antituberculosis and antimalarial substances. A proposed amendment of the WHO GMP guidelines for APIs had been discussed previously but had not been adopted by the Committee. The Committee recommended that  

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