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WHO Expert Committee on Specifications for Pharmaceutical Preparations

Fiftieth Report

WHO Expert Committee on Specifications for Pharmaceutical Preparations by WHO
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The World Health Organization (WHO) ExpertCommittee on Specifications for PharmaceuticalPreparations advises the Director-General of WHO inthe area of medicines quality assurance. It providesindependent expert recommendations and guidance toensure that medicines meet standards of quality safetyand efficacy in all WHO Member States. Its advice isdeveloped through a broad consensus-building processand covers all areas of quality assurance of medicines from their development to their distribution to patients.In the area of quality control the Expert Committeereviewed new and revised specifications and generaltexts for inclusion in The International Pharmacopoeia and received the annual report of the EuropeanDirectorate for the Quality of Medicines & HealthCare(EDQM) the custodian centre for International ChemicalReference Substances (ICRS). The Committee adopteda number of monographs general texts and ICRS. Itnoted the report on Phase 6 of the External QualityAssurance Assessment Scheme (EQAAS) and on newapproaches to ensure sustainability of this schemethrough user fees. The Committee further acknowledged the progress of good pharmacopoeialpractices (GPhP) and adopted the document onGPhP which was prepared by the consecutive internationalmeetings of world pharmacopoeias.In the various quality assurance-related areas theExpert Committee was presented with a numberof new and revised guidelines related to goodmanufacturing practices (GMP) distribution and tradeof pharmaceuticals and regulatory practice. It adopted10 guidelines as listed below as well as 22 new specifications and general texts for inclusion in The International Pharmacopoeia. The Committee took note of ongoing work to promote collaborationand information exchange through the good regulatorypractice project and welcomed the development ofa comprehensive set of guidelines for all national regulatory authorities through this project.
World Health Organization; February 2016
374 pages; ISBN 9789240695481
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Title: WHO Expert Committee on Specifications for Pharmaceutical Preparations
Author: WHO
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