21 Code of Federal Regulation(中英对照).doc

21 Code of Federal Regulations Parts 210 and 211 联邦法规21 210与211部分 Part 210 - CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL Part 211 - CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS 210部分---现行药品生产质量管理规范; 制造、加工、包装或贮存总则 211部分---现行药物制剂生产质量管理规范 Part 210 - CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL 210 -现行药品生产质量管理规范; 制造、加工、包装或贮存总则 210.1 Status of current good manufacturing practice regulations. 210.1现行药品生产质量管理规范法规的状况 210.2 Applicability of current good manufacturing practice regulations. 210.2现行药品生产质量管理规范法规的适用性 210.3 Definitions. 210.3 定义 AUTHORITY: Secs. 201, 501, 502, 505, 506, 507, 512, 701, 704 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 351, 352, 355, 356, 357, 360b, 371, 374). 参考文献：《联邦食品、药物和化妆品法》第（21 U.S.C. 321, 351, 352, 355, 356, 357, 360b, 371, 374）201、501、502、505、506、507、512、701、704章 SOURCE: 43 FR 45076, Sept. 29, 1978, unless otherwise noted. 原始资料：43 联邦法规45076，1978年9月29日。除非另有说明。 210.1 Status of current good manufacturing practice regulations. 210.1现行药品生产质量管理规范法规的状况 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. 本部分和本章211部分至226部分的法规，包含了在应用的方法、设施或控制装置的使用、制造、工艺、包装或贮存方面现行的最低限度的药品生产质量管理规范，目的在于确保这些药品达到法规中规定的安全标准，具有标示和剂量提示，并且符合应有的质量和纯度属性。 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 to be adulterated under section 501(a)(2)(B) of the act and such dr