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生物制品是一种特殊的药品,分为预防类生物制品、诊断类生物制品和治疗类生物制品三大类。由于生物制品不同于普通药品,有其独特的属性和特性,国家对生物制品的管理也有特别要求,实行从原材料、中间品、成品、运输、贮存、使用、生产全过程监控[1]。国家对疫苗类制品、血液制品、用于血源筛查的体外诊断试剂,以及国家食品药品监督管理局规定的其他生物制品,每批出厂上市或者进口时进行强制性检验、审核的制度。
Biological products is a special kind of medicine, divided into three categories of preventive biological products, diagnostic biological products and therapeutic biological products. Since biological products are different from ordinary drugs, they have unique properties and characteristics. Countries also have special requirements for the management of biological products. Monitoring and monitoring of the whole process of raw materials, intermediate products, finished products, transportation, storage, use and production have been carried out. The state carries out compulsory examination and approval system for vaccine products, blood products, in vitro diagnostic reagents for blood screening and other biological products regulated by the State Food and Drug Administration.