药学英语药学英语 (40).pptVIP

Unit Twelve Good Manufacturing Practices (GMP) Part two 1. USA/ GMP Regulations 美国GMP法规 The USA Food, Drugs and Cosmetics Act (FDC Act) states that All drugs shall be manufactured, processed and packaged in accordance with current good manufacturing practice”. No distinction is drawn between the manufacture of drug products (secondary manufacture) and the manufacture of APIs (primary manufacture). 《联邦食品、药品和化妆品法案》(FD＆C 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)”。 It is also noted in the preamble [?pri??mbl]