Reports the work of an expert committee commissioned to identify and establish international standards and reference reagents for biological substances. Held and distributed by WHO International Laboratories for Biological Standards, these reference materials are widely used by national control authorities and manufacturers to ensure worldwide uniformity when designating the potency, activity, or specificity of biologicals used in prophylaxis, therapy or diagnosis of disease. The committee also issues guidelines and detailed requirements for the manufacturing and quality control of selected biologicals. The report has two parts. The first part briefly considers general issues affecting the committee s work, explains the decision to issue new or revised requirements for two vaccines, and reviews the need to establish, replace, or discontinue some 55 international reference materials. Ten new or replacement reference materials were established. The second and most extensive part issues detailed requirements for the manufacturing and quality control of two vaccines. Revised requirements were issued for live varicella vaccine. Revisions reflect the extensive experience gained by manufacturers since the initial requirements were established in 1984. The committee also issued new requirements for inactivated vaccine against haemorrhagic feverwith renal syndrome, an acute interstitial nephropathy caused by viruses belonging to the Hantavirus genus of the family Bunyaviridae.

DC.HQ

eng fre rus spa.

WHODOC

WHO monograph

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