WHO Good Practices for Pharmaceutical Quality Control Laboratories. WHO Technical Report Series, No. 957, 2010, Annex 1

The WHO Expert Committee on Specifications for Pharmaceutical Products adopted in 1999 the guidelines entitled WHO Good practices for national pharmaceutical control laboratories, which were published as Annex 3 of the WHO Technical Report Series, No. 902, 2002. As the other guidelines related to laboratory quality assurance have been updated and subsequent inspections for the compliance with the guidelines on good practices for national pharmaceutical control laboratories indicated that some sections were in need of improvement and clarification, it was considered necessary to prepare a revised text. These guidelines provide advice on the quality management system within which the analysis of active pharmaceutical ingredients (APIs), excipients and pharmaceutical products should be performed to demonstrate that reliable results are obtained.