WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 1003 - Fifty-first Report (Geneva, 17–21 October 2016)
(2017; 252 pages)

Abstract

The 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. WHO guidelines for selecting marker substances of herbal origin for quality control of herbal medicines; The International Pharmacopoeia: revised concepts and future perspectives; Prequalification of quality control laboratories. Procedure for assessing the acceptability, in principle, of quality control laboratories for use by United Nations agencies; WHO Global Model Regulatory Framework for Medical Devices including in vitro diagnostic medical devices; General background notes on the list of international comparator pharmaceutical products; Equilibrium solubility experiments for the purpose of classification of active pharmaceutical ingredients according to the Biopharmaceutics Classification System, as an appendix to the WHO guidelines on Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability (Annex 7, WHO Technical Report Series, No. 992, 2015).

 
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