Who Expert Committee on Specifications for Pharmaceutical Preparations: Thirty Eighth Report (Technical Report Series)

This report presents the recommendations of an international group of experts convened by the World Health Organization to consider matters concerning the quality assurance of pharmaceuticals and specifications for drug substances and dosage forms. Of particular relevance to drug regulatory authorities and pharmaceutical manufacturers, this report discusses the latest volume of the International Pharmacopoeia and quality specifications for pharmaceutical substances and dosage forms, as well as quality control of reference materials, good manufacturing practices (GMP), inspection, distribution and trade and other aspects of quality assurance of pharmaceuticals, and regulatory issues. The report is complemented by a number of annexes, including recommendations on good trade and distribution practices for pharmaceutical starting materials, guidelines on the WHO scheme for the certification of pharmaceutical materials moving in international commerce, draft procedures for assessing quality control laboratories and procurement agencies for use by the United Nations agencies, and guidelines for preparing a laboratory information file and a procurement agency information file