Quality assurance is a wide-ranging concept covering all matters that individually or collectively influence the quality of a product. With regard to pharmaceuticals, quality assurance can be divided into major areas, including quality control, production, distribution and inspections. The development of norms, standards and guidelines to promote quality assurance is an integral part of WHO’s Constitution and has been endorsed and supported through numerous World Health Assembly resolutions, and in those on the Revised Drug Strategy.

The WHO guidelines relating to quality assurance included in this collection have been prepared in consultation with the WHO Expert Advisory Panel on The International Pharmacopoeia and Pharmaceutical Preparations, with specialists from industry, national institutions, nongovernmental organizations, etc., through a vast global consultative process. The draft guidelines are evaluated during the meetings of the WHO Expert Committee on Specifications for Pharmaceutical Preparations and, if found suitable, adopted as international standards. This Committee meets every year and each report (published in the WHO Technical Report Series) includes all adopted guidelines in the form of annexes. Full reports can be retrieved on the web as follows:

All these elements are intended for use by national and regional regulatory authorities, manufacturers and other interested parties.

Please consult the Help page for any help or to set the search preferences.