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WHO Expert Committee on Specifications for Pharmaceutical ...

WHO Expert Committee on Specifications for Pharmaceutical PreparationsThe Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new guidelines were adopted and recommended for use: Development of monographs for e International Pharmacopoeia; WHO good manufacturing practices: water for Pharmaceutical use; Pharmaceutical development of multisource (generic) Pharmaceutical products points to consider; Guidelines on submission of documentation for a multisource (generic) finished Pharmaceutical product for the WHO Prequalification of Medicines

iv WHO Technical Report Series No. 970, 2012 WHO Expert Committee on Specifications for Pharmaceutical Preparations Forty-sixth report 5. Quality control – national laboratories 27 5.1 External Quality Assurance Assessment Scheme 27

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