CGMP20100820中英整理版.docVIP

CURRENT GOOD MANUFACTURE PRACTICE (Part 210 211) 美国药品生产质量管理规范（CGMP） 210及211部分 中英对照版 Content 210 CGMP of Drugs；general 药品生产，加工，包装，储存CGMP总则……………..….... 2 211 CGMP For Finished Pharmaceuticals 成品药物的CGMP……………..…………………. 8 211-A General Provision总则…………………………………………………..…… ………… 8 211-B Organization Personnel机构与人员………………………………..……………… … 9 211-C Building Facilities厂房和设施…………………………………..…………………… 11 211-D Equipment设备………………………………………………….………………………. 14 211-E Control of Components Drug Product Containers Closures成份，药品容器和密封件的控制……………………………..………………………….……………………….. 16 211-F Production Process Control生产与过程控制……………………………………….... 21 211-G Packaging Labeling Control包材与标签控制…………………...……………….…... 24 211-H Holding Distribution贮存与销售……………………….…………………..………... 31 211- I Laboratory Controls实验室控制………………………………………………………... 32 211- J Records Reports记录与报告…………………………………………..……………... 38 211- k Returned and Salvaged Drug Products 退货的药品和回收处理………………………... 46 Part 210 CURRENT GOOD MANUFACTURING PRACTICE IN MAUNUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL 210 部分 药品生产，加工，包装和储存CGMP；总则 Sec. 210.1 Status of current good manufacturing practice regulations. CGMP法规的地位 (a) The regulations set forth in this part and in parts 211 through 226 of this chapter contain the minimum current good manufacturing practice for methods to be used in, and the facilities or controls to be used for, the manufacture, processing, packing, or holding of a drug to assure that such drug meets the requirements of the act as to safety, and has the identity and strength and meets the quality and purity characteristics that it purports or is represented to possess. 在本部分及211—226部分章节中陈述的法规是在厂房设施及药品生产、加工、包装或贮存控制中使用的现行生产质量管理规范的最低标准，用于保证该药品符合法规对安全、特性和规格的要求，以及所示质量和纯度要求。 (b) The failure to comply with any regulation set forth in this part and in parts 211 through 226 of this chapter in the manufacture, processing, packing, or holding of a drug shall render such drug