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WHO Quality Assurance Compendium

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: en/index.html

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


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All WHO medicines quality assurance guidelines are included in the following groupings:

· Distribution
· Inspections
· Production
· Quality control
· Related regulatory standards
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About this CD-ROM
This CD-ROM was produced by the WHO Medicines Quality Assurance Programme with the help of Human Info NGO/WIT and its logistic partner HumanityCD Ltd, and the University of Waikato, New Zealand, using the Greenstone software of the New Zealand Digital Library. It also includes Mozilla Firefox, distributed by Human Info NGO/WIT.
© World Health Organization, 2010