cMGP中英对照版印刷版.pdfVIP

00cMGP 中英对照版印刷版2 210 and 211 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—人用及兽用药品的生产、加工、包装或贮存的CGMP （概述） 211 部分—制剂药品的 CGMP Part 210 - CURRENT GOOD 210 部分—人用及兽用药品的生产、加 MANUFACTURING PRACTICE IN 工、包装或贮存的 CGMP MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL 210.1 Status of current good manufacturing 210.1 cGMP 法规的地位 practice regulations. 210.2 cGMP 法规的适用性 210.2 Applicability of current good manufacturing practice regulations. 210.3 定义 210.3 Definitions. 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). SOURCE: 43 FR 45076, Sept. 29, 1978, unless otherwise noted. § 210.1 Status of current goo 210.1 cGMP 法规的地位 manufacturing practice regulations. (a) 在本部分及 21CFR 211—226 部分中陈 (a) The regulations set forth in this part and in 述的法规是在药品生产、加工、包装或贮存 Parts 211 through 226 of this chapter contain 中使用的现行生产质量治理规范及使用的 the minimum current good manufacturing 设施或操纵的最低标准，以保证该药品符合 practice for methods to be used in, and the 联邦食品、药品及化妆品法对安全性的要 facilities or controls to be used for, the 求，具有均一性和效价(或含量)并符合或代 manufacture, processing, packing, or holding of 表其生产过程的质量及纯度等特点。 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. (b) The failure to comply with any regulation set (b) 凡是在药品生产、加工、包装或贮存 forth in this part and in Part