WHO Expert Committee on Specifications for Pharmaceutical Preparations
Forty-first Report
Technical Report Series, No 943
World Health Organization
ISBN-13    9789241209434 ISBN-10    9241209437
Order Number    11000943 Format    Package
Price    CHF    30.00 / US$    36.00 Developing countries:    CHF    21.00
English     2007        167   pages
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Summary
The Expert Committee on Specifications for Pharmaceutical Preparations reviews developments in the quality assurance of medicines and provides advice and recommendations to help combat problems caused by counterfeit and substandard medicines. In this respect, it coordinates activities that lead to the adoption of recommendations and provides tools to assure the quality of medicines and the materials from which they are prepared. The committee is involved in developing quality control specifications and International Chemical Reference Substances, focusing on essential medicines and on medicines for which no international quality requirements are publicly available but which are used to treat large numbers of people .

This report includes the following guidelines of direct relevance to the United Nations Prequalification Programme for Priority Essential Medicines and for quality control laboratories: procedures governing the assessment of pharmaceutical products for procurement by United Nations agencies and for assessing the acceptability of quality control laboratories for use by United Nations agencies, as well as guidance on variations to a prequalified product dossier. Adopted also were several monographs for inclusion in The International Pharmacopoeia; in particular for antiretrovirals, including fixed-dose combinations, TB medicines, and antimalarial and paediatric medicines.