药学英语药学英语 (40).ppt
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1、 Unit Twelve Good Manufacturing Practices (GMP)Part two 1.USA/GMP Regulations 美国美国GMP法规法规vThe USA Food,Drugs and Cosmetics Act(FD&C Act)states that All drugs shall be manufactured,processed and packaged in accordance with current good manufacturing practice”.vNo distinction is drawn between the manu
2、facture of drug products(secondary manufacture)and the manufacture of APIs(primary manufacture).v联邦食品、药品和化妆品法案(FDC Act)中规定,无论是制剂生产(二次制造)还是原料药生产(一次制造)“所有药品的生产、加工和包装必须符合现行药品生产质量管理规范(cGMP)”。vIt is also noted in the preamble primbl 序言 to the FD&C Act that the act applies to all drugs for human use,and t
3、his therefore includes the requirement for both APIs and drug products manufactured for clinical trials,to be manufactured according to Current Good Manufacturing Practice(cGMP).v在FDC Act的序言中,注明了该法案用于所有的人用药物,因而临床试验用的原料药和制剂生产也要符合cGMP。vThe requirements for compliance to cGMP are laid down 被主张 in the f
4、ollowing Code of Federal Regulations(21CFR):vPart 210 Current Good Manufacturing Practice in manufacturing,processing,packing or holding of drugs:vPart 211 Current Good Manufacturing Practice for finished pharmaceuticals.v在以下的联邦法规21CFR中对遵守cGMP作了要求:v210部分 药品生产、加工、包装和贮存的 cGMPv211部分 成品的cGMPvIt must be
5、noted that the US regulations refer to current GMP.vThe regulations as detailed in 21CFR parts 210 and 211,give the pharmaceutical manufacturer plenty of scope to interpret the requirements appropriately for his specific facility and process,but in doing this,the regulations require the manufacturer
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