WHO Technical Report Series Series 1003

WHO Expert Committee on Specifications for Pharmaceutical Preparations

Fifty-first Report

May 2017
More details
  • Publisher
    World Health Organization
  • Published
    11th May 2017
  • ISBN 9789241210034
  • Language English
  • Pages 246 pp.
  • Size 6.25" x 9.5"

The Expert Committee on Specifications for Pharmaceutical Preparations works toward 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 guideline on Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability (Annex 7, WHO Technical Report Series 992, 2015)

World Health Organization

World Health Organization is a Specialized Agency of the United Nations, charged to act as the world's directing and coordinating authority on questions of human health. It is responsible for providing leadership on global health matters, shaping the health research agenda, setting norms and standards, articulating evidence-based policy options, providing technical support to countries, and monitoring and assessing health trends.