WHO Expert Committee on Specifications for Pharmaceutical Preparations

Abstract

The production, distribution and sale of counterfeit or substandard pharmaceutical products on the world market are of increasing concern to drug authorities and the international agencies that recommend standards for ensuring the quality, efficacy and safety of drugs. This report of an international group of experts convened by the World Health Organization presents recommendations concerning the quality assurance of pharmaceuticals and specifications for drug substances and dosage forms. It looks at activities related to the further development of The international pharmacopoeia and also covers good manufacturing practices, inspection and monitoring, and drug regulatory legislation. The aim of the report, of particular relevance to drug regulatory authorities, is to provide guidance to promote harmonization at an international level and encourage countries to establish and strengthen their own regulatory systems through national legislation and training programmes. A number of annexes attached to the report further develop areas where countries might themselves take action, and include detailed examples of provisional legislation and guidelines on specific aspects of good manufacturing practice, the inspection of drug distribution channels, and the development of training programmes for the inspection and examination of counterfeit pharmaceuticals.