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A model quality assurance system for procurement agencies : recommendations for quality assurance systems focusing on prequalification of products and manufacturers, purchasing, storage and distribution of pharmaceutical products


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This report is intended to assist organisations purchasing pharmaceutical products, vaccines or other health sector goods, or who are otherwise involved in the prequalification, purchasing, storage and distribution of such products. It addresses the general requirement for the quality assurance system that needs to be in place at all procurement agencies and sets out recommendations that these agencies should implement when evaluating product needs, assessing the products offered and the manufacturing and supply arrangements. It also describes principles of purchasing pharmaceutical products, how to receive and store them; good distribution practices; and monitoring and reassessment of products and contracted-out activities. This document was previously published as Annex 6 of the 40th Report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations (Technical report 937, 2006).


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