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[Requirements on the production and testing of sera and vaccines]
Fortschritte Der Medizin
|June 16, 1977
Abstract:
After discussion of the legal basis for licencing and release of sera and vaccines the procedures practiced in Western Germany and in the USA are compared. The value of specified tests required in routine control for safety and efficacy of biological products is discussed. The best means to control biological products in the opinion of the author is a continuous quality control during the entire process of production.