WHO Expert Committee on Specifications for Pharmaceutical Preparations. Forty-first report

Abstract

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. The report is complemented by a number of annexes. These include: guidance notes on related substances tests concerning the dosage form monographs of The International Pharmacopoeia; a list of available International Chemical Reference Substances and International Infrared Reference Spectra; a revision of the general guidelines for the establishment, maintenance and distribution of chemical reference substances; the procedure for assessing the acceptability, in principle, of pharmaceutical products for purchase by United Nations agencies; the procedure for assessing the acceptability, in principle, of quality control laboratories for use by United Nations agencies; and guidance on variations to a prequalified product dossier.