Presents three sets of detailed guidelines intended to assist manufacturers and national control authorities in their efforts to assure that vaccines and other biological products are safe and efficacious. The guidelines respond to several specific problems of quality control that arise whenever biological processes and materials, such as cultivation of cells or extraction of material from living organisms, are used to manufacture pharmaceutical products. The first guidelines, which cover good manufacturing practices specific to biological products, are intended to supplement the more general guidelines on "Good manufacturing practices for pharmaceutical products", also issued by WHO in 1992 (see below). Because tests of the final biological product can fail to detect certain deficiencies and therefore cannot alone guarantee quality, the guidelines concentrate on the strict in-process controls that must be adhered to at each stage of production, beginning with the production of active ingredients. The second guidelines describe the measures that should be taken by national control authorities and national control laboratories toassure the safety and efficacy of biological products. The third guidelines set out requirements for assuring the quality of murine and human monoclonal antibodies for use in humans, including in vivo diagnosis and ex vivo treatment. Presented in two parts, with the first addressed to manufacturers and the second to national control authorities, the guidelines emphasize the strict precautions needed to prevent microbial contamination, especially by viruses. Each section includes requirements, which may be used as definitive national requirements, and comments and recommendations for guidance. Other sections provide an updated, complete list of codes for antimicrobic susceptibility discs and a list of laboratories approved by WHO for the production of yellow fever vaccine. The report also issues updated information on changes in the status of international reference materials, which are held and distributed by four main international laboratories for use in the standardization and control of biologicals.

eng fre rus spa.

WHODOC

WHO monograph

4