WHO Expert Committee on Biological Standardization [meeting held in Geneva from 24 to 31 October 1989] : fortieth report

Abstract

Reports the work of an expert committee commissioned to coordinate the international activities needed to assure the production of safe, potent, and stable prophylatic and therapeutic agents. Work includes the establishment and monitoring of international standard reference materials, in line with changing patterns of clinical use, and the recommendation of requirements to e fulfilled by individual preparations in order to assure their quality and effectiveness. The publication of recommended requirements and advice on the status of international reference materials is intended to facilitate the exchange of biological substances between different countries and to provide guidance to manufacturers, national licensing and control authorities, and others who may have to decide upon appropriate methods of assay and control. The most extensive part of the report issues revised requirements for the manufacturing and control of poliomyelitis vaccine and for diphtheria, tetanus, pertussis, and combined vaccines. The revised requirements for diphtheria, tetanus, pertussis, and combined vaccines place special emphasis on methods of determining the potency of vaccines that would require a smaller number of animals and, for combined vaccines, on the further tests required after blending. The report also sets out detailed procedures to be followed in the preparation, characterization, and establishment of international biological reference materials, including guidelines that can assist national control authorities and individual laboratories in the preparation and establishment of national or laboratory working standards