21CFR210中英文对照版(SMART).pdf

Part 210 - CURRENT GOOD MANUFACTURING 210 部分— 人用及兽用药 品的生产 、加工、包装或贮存 的 PRACTICE IN MANUFACTURING, PROCESSING, CGMP PACKING, OR HOLDING OF DRUGS; GENERAL 210.1 Status of current good manufacturing practice 210.1 cGMP法规的地位 regulations. 210.2 Applicability of current good manufacturing practice 210.2 cGMP法规的适用性 regulations. 210.3 Definitions. 210.3 定义 § 210.1 Status of current good manufacturing practice 210.1 cGMP法规的地位 regulations. (a) The regulations set forth in this part and in Parts 211 through 226 of this chapter contain the minimum current (a) 在本部分及21CFR 211—226部分中陈述的法规是在药 good manufacturing practice for methods to be used in, 品生产、加工、包装或贮存中使用的现行生产质量管理规 and the facilities or controls to be used for, the 范及使用的设施或控制的最低标准，以保证该药品符合联 manufacture, processing, packing, or holding of a drug to 邦食品、药品及化妆品法对安全性的要求，具有均一性和 assure that such drug meets the requirements of the act 效价(或含量)并符合或代表其生产过程的质量及纯度等特 as to safety, and has the identity and strength and meets 征。 the quality and purity characteristics that it purports or is (b) The failure to comply with any regulation set forth in this part and in Parts 211 through 226 of this chapter in (b) 凡是在药品生产、加工、包装或贮存过程中存在任何 the manufacture, processing, packing, or holding of a 不符合本部分及21CFR 211—226部分中陈述的法规的药 drug shall render such drug to be adulterated under 品，依据联邦食品、药品及化妆品法501 (a)(2)-(B)，该 section 501(a)(2)(B) of the act and such drug, as well as 药应被视为劣药，同时导致该事故发生的负责人应受相应 the person who is responsible for the failure to comply, 的法规的制裁。 shall be subject to regulatory action. § 210.2 Applicability of current good manufacturing