WHO Expert Committee on Specifications for Pharmaceutical Preparations [meeting held in Geneva from 10 to 15 December 1990] : thirty second report

Abstract

Issues five sets of detailed guidelines intended to assist drug regulatory authorities in implementing a rigorous, comprehensive system for the quality control of pharmaceutical products. Focused on key components in a national system for quality assurance, the guidelines set out up-to-date principles, procedures, standards and requirements that can assist both regulators and manufacturers in their efforts to control the safety, quality, potency, and efficacy of pharmaceutical products The first and most extensive guidelines present updated requirements for good manufacturing practices in pharmaceutical production. The requirements, which are presented in three main parts, have been considerably revised and expanded from the 1975 version to reflect advances in pharmaceutical manufacturing technology. Part one outlines the general concepts and essential elements of quality assurance in the production of pharmaceuticals. The second part, on good practices in production and quality control, offers guidance on actions to be taken separately by production and by quality control personnel for the implementation of the general principles of quality assurance. The third part sets out supplementary guidelines for the manufacture of sterile preparations and the production of active pharmaceutical ingredients. The second guidelines provide a step-by-step description of the procedures to be followed during the inspection of pharmaceutical manufacturing facilities in order to ascertain adherence to good manufacturing practices. The third guidelines cover implementation of the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce, which has also been revised and considerably strengthened. To make the certification procedures better suited to rigorous control, particularly in view of the increasingly numerous reports of substandard and counterfeit drugs found on the market in developing countries, three different forms of attestation are proposed. Additional guidelines cover the quality of pharmaceutical and biological products prepared by recombinant DNA technology, and the validation of analytical procedures used in the examination of pharmaceutical products to ensure safety and efficacy at all stages of shelf-life, including storage, distribution and use. The remaining sections provide updated lists of available international chemical reference substances and of adopted international infrared reference spectra, and outline a protocol for a study on the quality of selected drugs at the point of use in developing countries