[Requirements on the production and testing of sera and vaccines].
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.
D001428:Bacterial Vaccines / Q000032:analysis; D004340:Drug Contamination; D005860:Germany, West; D006801:Humans; D007106:Immune Sera / Q000032:analysis / Q000592:standards*; D007880:Legislation, Drug; D011786:Quality Control; D014612:Vaccines / Q000032:analysis / Q000592:standards*; D014613:Vaccines, Attenuated / Q000032:analysis; D014765:Viral Vaccines / Q000032:analysis
D001428:Bacterial Vaccines; D007106:Immune Sera; D014612:Vaccines; D014613:Vaccines, Attenuated; D014765:Viral Vaccines
Anforderungen an die Herstellung und Prüfung von Sera und Impfstoffen.