美国cGMP 中英文对照版
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(a) The regulations in this part and in parts 211 through 226 of this chapter as they may pertain to a drug; in parts 600 through 680 of this chapter as they may pertain to a biological product for human use; and in part 1271 of this chapter as they are applicable to a human cell, tissue, or cellular or tissue-based product (HCT/P) that is a drug (subject to review under an application submitted under section 505 of the act or under a biological product license application under section 351 of the Public Health Service Act); shall be considered to supplement, not supersede, each other, unless the regulations explicitly provide otherwise. In the event of a conflict between applicable regulations in this part and in other parts of this chapter, the regulation specifically applicable to the drug product in question shall supersede the more general. (a) 本部分及21CFR 211—226适用于普通药品，21CFR 600—680适用于人用生物制品，除非另 有明确规定，否则上述两者之间应该是相互补充而不是相互取代。如有上述两部分的法规不适用 的药品，则可用特定的具体法规来替代。
美国 cGMP 中英文对照版
美国药品生产质量管理规范
210部分和211部分 PART 210 CURRENT GOOD MANUFACTURING PRACTICE IN
MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL 210部分 人用及兽用药品的生产、加工、包装或贮存的CGMP
编者说明：英文版2010-05-23取自FDA官方网站 中文版取自中国GMP网友关大鹏2009-12-18的发的2003-12译本 两个版本可能稍有不同，不同之处红字标示。
1-58
美国 cGMP 中英文对照版
目
录
210.1 cGMP法规的地位……………………………………………………
2
210.2 cGMP法规的适用性…………………………………………………
(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. (a) 在本部分及21CFR 211—226部分中陈述的法规是在药品生产、加工、包装或贮存中使用的 现行生产质量管理规范及使用的设施或控制的最低标准，以保证该药品符合联邦食品、药品及化 妆品法对安全性的要求，具有均一性和效价(或含量)并符合或代表其生产过程的质量及纯度等特 征。
(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 to be adulterated under section 501(a)(2)(B) of the act and such drug, as well as the person who is responsible for the failure to comply, shall be subject to regulatory action. (b) 凡是在药品生产、加工、包装或贮存过程中存在任何不符合本部分及21CFR 211—226部分中 陈述的法规的药品，依据联邦食品、药品及化妆品法501 (a)(2)-(B)，该药应被视为劣药，同时
2-58
美国 cGMP 中英文对照版 导致该事故发生的负责人应受相应的法规的制裁。
(c) Owners and operators of establishments engaged in the recovery, donor screening, testing (including donor testing), processing, storage, labeling, packaging, or distribution of human cells, tissues, and cellular and tissue-based products (HCT/Ps), as defined in 1271.3(d) of this chapter, that are drugs (subject to review under an application submitted under section 505 of the act or under a biological product license application under section 351 of the Public Health Service Act), are subject to the donor-eligibility and applicable current good tissue practice procedures set forth in part 1271 subparts C and D of this chapter, in addition to the regulations in this part and in parts 211 through 226 of this chapter. Failure to comply with any applicable regulation set forth in this part, in parts 211 through 226 of this chapter, in part 1271 subpart C of this chapter, or in part 1271 subpart D of this chapter with respect to the manufacture, processing, packing or holding of a drug, renders an HCT/P adulterated under section 501(a)(2)(B) of the act. Such HCT/P, as well as the person who is responsible for the failure to comply, is subject to regulatory action.
2
210.3 定义…………………………………………………………………
2
211-A- 总则…………………………………………………………………
4
211-B- 组织与人员…………………………………………………………
4
211-C- 厂房和设施…………………………………………………………
5
211-D- 设备…………………………………………………………………
(b) If a person engages in only some operations subject to the regulations in this part, in parts 211 through 226 of this chapter, in parts 600 through 680 of this chapter, and in part 1271 of this chapter, and not in others, that person need only comply with those regulations applicable to the operations in which he or she is engaged.
3-58
美国 cGMP 中英文对照版 (c) An investigational drug for use in a phase 1 study, as described in 312.21(a) of this chapter, is subject to the statutory requirements set forth in 21 U.S.C. 351(a)(2)(B). The production of such drug is exempt from compliance with the regulations in part 211 of this chapter. However, this exemption does not apply to an investigational drug for use in a phase 1 study once the investigational drug has been made available for use by or for the sponsor in a phase 2 or phase 3 study, as described in 312.21(b) and (c) of this chapter, or the drug has been lawfully marketed. If the investigational drug has been made available in a phase 2 or phase 3 study or the drug has been lawfully marketed, the drug for use in the phase 1 study must comply with part 211.
14
211-J- 记录和报告…………………………………………………………
16
Biblioteka Baidu211-K- 退回的药品和回收处理……………………………………………
20
Sec. 210.1 Status of current good manufacturing practice regulations. 210.1 cGMP法规的地位
7
211-E- 成份、药品容器和密封件的控制…………………………………
8
211-F- 生产和加工控制……………………………………………………
10
211-G- 包装和标签控制……………………………………………………
11
211-H- 贮存和销售…………………………………………………………
13
211-I- 实验室控制…………………………………………………………
[43 FR 45076, Sept, 29, 1978, as amended at 69 FR 29828, May 25, 2004]
Sec. 210.2 Applicability of current good manufacturing practice regulations. 210.2 cGMP法规的适用性
美国 cGMP 中英文对照版
美国药品生产质量管理规范
210部分和211部分 PART 210 CURRENT GOOD MANUFACTURING PRACTICE IN
MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL 210部分 人用及兽用药品的生产、加工、包装或贮存的CGMP
编者说明：英文版2010-05-23取自FDA官方网站 中文版取自中国GMP网友关大鹏2009-12-18的发的2003-12译本 两个版本可能稍有不同，不同之处红字标示。
1-58
美国 cGMP 中英文对照版
目
录
210.1 cGMP法规的地位……………………………………………………
2
210.2 cGMP法规的适用性…………………………………………………
(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. (a) 在本部分及21CFR 211—226部分中陈述的法规是在药品生产、加工、包装或贮存中使用的 现行生产质量管理规范及使用的设施或控制的最低标准，以保证该药品符合联邦食品、药品及化 妆品法对安全性的要求，具有均一性和效价(或含量)并符合或代表其生产过程的质量及纯度等特 征。
(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 to be adulterated under section 501(a)(2)(B) of the act and such drug, as well as the person who is responsible for the failure to comply, shall be subject to regulatory action. (b) 凡是在药品生产、加工、包装或贮存过程中存在任何不符合本部分及21CFR 211—226部分中 陈述的法规的药品，依据联邦食品、药品及化妆品法501 (a)(2)-(B)，该药应被视为劣药，同时
2-58
美国 cGMP 中英文对照版 导致该事故发生的负责人应受相应的法规的制裁。
(c) Owners and operators of establishments engaged in the recovery, donor screening, testing (including donor testing), processing, storage, labeling, packaging, or distribution of human cells, tissues, and cellular and tissue-based products (HCT/Ps), as defined in 1271.3(d) of this chapter, that are drugs (subject to review under an application submitted under section 505 of the act or under a biological product license application under section 351 of the Public Health Service Act), are subject to the donor-eligibility and applicable current good tissue practice procedures set forth in part 1271 subparts C and D of this chapter, in addition to the regulations in this part and in parts 211 through 226 of this chapter. Failure to comply with any applicable regulation set forth in this part, in parts 211 through 226 of this chapter, in part 1271 subpart C of this chapter, or in part 1271 subpart D of this chapter with respect to the manufacture, processing, packing or holding of a drug, renders an HCT/P adulterated under section 501(a)(2)(B) of the act. Such HCT/P, as well as the person who is responsible for the failure to comply, is subject to regulatory action.
2
210.3 定义…………………………………………………………………
2
211-A- 总则…………………………………………………………………
4
211-B- 组织与人员…………………………………………………………
4
211-C- 厂房和设施…………………………………………………………
5
211-D- 设备…………………………………………………………………
(b) If a person engages in only some operations subject to the regulations in this part, in parts 211 through 226 of this chapter, in parts 600 through 680 of this chapter, and in part 1271 of this chapter, and not in others, that person need only comply with those regulations applicable to the operations in which he or she is engaged.
3-58
美国 cGMP 中英文对照版 (c) An investigational drug for use in a phase 1 study, as described in 312.21(a) of this chapter, is subject to the statutory requirements set forth in 21 U.S.C. 351(a)(2)(B). The production of such drug is exempt from compliance with the regulations in part 211 of this chapter. However, this exemption does not apply to an investigational drug for use in a phase 1 study once the investigational drug has been made available for use by or for the sponsor in a phase 2 or phase 3 study, as described in 312.21(b) and (c) of this chapter, or the drug has been lawfully marketed. If the investigational drug has been made available in a phase 2 or phase 3 study or the drug has been lawfully marketed, the drug for use in the phase 1 study must comply with part 211.
14
211-J- 记录和报告…………………………………………………………
16
Biblioteka Baidu211-K- 退回的药品和回收处理……………………………………………
20
Sec. 210.1 Status of current good manufacturing practice regulations. 210.1 cGMP法规的地位
7
211-E- 成份、药品容器和密封件的控制…………………………………
8
211-F- 生产和加工控制……………………………………………………
10
211-G- 包装和标签控制……………………………………………………
11
211-H- 贮存和销售…………………………………………………………
13
211-I- 实验室控制…………………………………………………………
[43 FR 45076, Sept, 29, 1978, as amended at 69 FR 29828, May 25, 2004]
Sec. 210.2 Applicability of current good manufacturing practice regulations. 210.2 cGMP法规的适用性