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C G M P中英文对照Table of Contents 目录• SUBPART B 111.10 – 111.14: Personnel 人员• SUBPART C 111.15 – 111.23: Physical Plant and Grounds 工厂与场所• SUBPART D 111.25 – 111.35: Equipment and Utensils 设备与器具• SUBPART E 111.55-111.95: Production and Process Control System 生产与过程控制系统• SUBPART F 111.103-111.140: Production and Process Control System:• Requirements for Quality Control 生产与过程控制系统对质量控制的要求• SUBPART G 111.153 – 111.180: Production and Process Control System:• Requirements for components, packaging, and labels 生产与过程控制系统对成分，包装与标签的要求• SUBPART H 111.205-111.210: Production and Process Control System:• Requirements for the Master Manufacturing Record. 生产与过程控制系统对主要制造记录的要求• SUBPART I 111.255 – 111.260: Production and Process Control System:• Require ments for the Batch Production Record. 生产与过程控制系统对批生产记录的要求• SUBPART J 111.303 – 111.325: Production and Process Control System:• Requirements for Laboratory Operations 生产与过程控制系统对实验室操作的要求• SUBPART K 111.353 – 111.365: Production and Process Control System• Requirements for Manufacturing Operations 生产与过程控制系统对制造过程的要求• SUBPART L 111.403 – 111.425: Production and process control system• Requirements for Packaging and Labels Operation 生产与过程控制系统对包装与标签操作的要求• SUBPART M 111.453 – 111.475: Holding and Distributing 扣留与分发• SUBPART N 111.503 – 111.535: Return of Dietary Supplements 膳食补充剂的退货• SUBPART O 111.553 – 111.570: Product Complaints 产品投诉• SUBPART P 111.605 – 111.610: Records and Recordkeeping 记录与记录保留• 11.10 – 11.50: Electronic Records 电子记录• N SF/ANSI 173 Section 8.2:• Compliance with the Public Health Security and Bioterrorism 符合公共健康安全与生物反恐• NSF/ANSI 173 Section 8.3: Adverse Event Reporting 不利事件的报告• NSF/ANSI 173 Section 8.4: Recall Procedures 回收程序• Appendix 1 NSF 229 – Functional Food Guideline 功能性食品导则• Appendix 2 NSF 306 – GMP for Sport 运动食品的GMP要求• Appendix 3 NSF 306 – GMP for Sport & NSF 229 – Functional Food Guideline• 运动食品与功能性食品的GMP要求• PERSONNEL• B人员Question 1 CFR 111.10Procedures have been established that define work requirements for personnel to prevent microbial contamination from illnesshygienic practices.建立员工工作要求的程序以预防疾病的微生物污染• a. A written procedure shall exist and be current stating that personnel with medical conditions such as open lesions or infected• 规定员工身体状况如开放性伤害或感染的书面程序必须存在并且为当前的• wounds will be removed from the manufacturing process so as to prevent product adulteration during manufacturing or storage.• 在制造或存储时有伤口的员工远离制造流程，以避免产品被掺杂• The procedure shall state that such health conditions will be reported to supervision.• 必须建立上述身体情况向主管汇报的程序，以便于监管• b. Inspection verifies that such workers are not in areas where adulteration could occur.• 有检查的验证表明上述的员工不在掺杂可能发生的区域• c. Personnel shall be trained on the written procedure and knowledgeable of the disease cont rol policies • 员工必须进行疾病控制方针的书面程序与知识的培训Question 2 CFR 111.10Hygienic practices have been established to include appropriate garments, personal hygiene, hand washing and sanitization, etc. prior to starting work and at any time whereby personnel can become soiled/contaminated.在工作前或员工被污染时需要建立包括适当的服装，员工卫生，洗手与消毒等的卫生操作• a. A written dress code shall exist and be current stating appropriate attire for workers, supervisors, managers and visitors to all parts of the production, storage, packaging and testing facilities.•表明员工，主管，经理，参观者进入生产，储存，包装与测试区域穿着适当服装的书面服装规则必须存在且为当前的• b. Outer garments shall be donned prior to entering the facility and shall not be worn outside the production facility or home. Therefore proper changing areas are required. Outer garments shall have long sleeves and have secured fasteners. Above waist pockets (or carrying items in pockets) should be avoided. •进入工厂前必须穿工作衣，并且不能在生产工厂外面或家里穿工作衣。
美国FDA CGMP英汉对照版Subpart A-General Provisions§211.1 Scopea)The regulations in this part contain theminimum current good manufacturing practice for preparation of drug products for administration to humans or animals.b)The current good manufacturing practiceregulations in this chapter, as they pertain to drug products, and in parts 600 through 680 of this chapter, as they pertain to biological products for human use, shall be considered to supplement, not supersede, the regulations in this part unless the regulations explicitly provide otherwise. In the event it is impossible to comply with applicable regulations both in this part and in other parts of this chapter or in parts 600 through 680 of this chapter, the regulation specifically applicable to the drug product in question shall supersede the regulation in this part.c)Pending consideration of a proposedexemption, published in the Federal Register of September 29, 1978, the requirements in this part shall not be enforced for OTC drug products if the products and all their ingredients are ordinarily marketed and consumed as human foods, and which products may also fall within the legal definition of drugs by virtue of their intended use. Therefore, until further notice, regulations under part 110 of this chapter, and where applicable, parts 113 to 129 of this chapter, shall be applied in determining whether these OTC drug products that are also foods are manufactured, processed, packed, or held under current good manufacturing practice.§211.3 Definitions.The definitions set forth in §210.3 of this chapter apply in this part.A．总则211．1 范围（a）本部分的条例包含人用或兽用药品制备的现行最低限度的药品生产管理规范（GMP）。
美国现行药品生产质量管理规范（cGMP）目录A-总则 (3)B-组织与人员 (3)C-厂房与设施 (4)D-设备 (7)E-成份、药品容器和密封件的控制 (8)F-生产和加工控制 (11)G-包装和标签控制 (13)H-贮存和销售 (16)I-实验室控制 (17)J-记录和报告 (20)K-退回的药品和回收处理 (25)A．总则211·1 范围(a) 本部分的条例包含人用或兽用药品制备的现行最低限度的药品生产质量管理规范(GMP)。
(b) 在本章里的这些针对药品的现行GMP条例和本章600至800的所有部分针对人用生物制品的现行GMP条例，除非明确另有说明者外，应认为是对本部分条例的补充,而不是代替。
本章其他部分或本章600至680各部分和本部分均可适用的条例,前部分的条例可代替本部分条例。
(c) 在考虑经提议的，发表在1978年9月29日联邦注册表（FR）上一项免除时,若产品及其所有成份是以人用物品形式作一般销售和消费，且这些产品根据其预期用途,亦可列入药品的范围内，则不应对这些非处方药(OTC)实施本部分条例，直至进一步的通知为止。
本章110部分和113至119部分的条例用于鉴别这些亦是食品的OTC药品是否按照GMP的要求生产、加工、包装和贮存。
211·3 定义本章210·3的定义适用于本部分。
B. 组织与人员211.22 质量控制部门的职责(a) 本部门有批准和拒收所有成份、药品包装容器、密封件、中间体、包装材料、标签及药品的职责与权力。
复查生产记录的权力，保证不产生差错，或若发生差错，保证他们充分调查这些差错。
本部门负责根据合同，批准或拒收由其它公司,生产、加工、包装或贮存的产品。
(b) 适当的实验室检验设备、批准（或拒收）的各种成份、药品容器、密封件、包装材料及药品，质量控制部门是可以获得的。
(c) 本部门有批准或驳回影响药品的均一性、效价或含量、质量及纯度的所有程序或规格标准的职责。
目录A．总则 (1)211．1 范围 (1)211．3定义 (1)B组织与人员 (2)211．22质量控制部门的指责 (2)211．25人员资格 (3)211．28人员职责 (4)211.34顾问 (4)C．厂房和设施 (5)211．42设计与建造特征 (5)211．44照明 (7)211．46通风、空气过滤、空气加热与冷却 (7)211．48管件 (8)211.50 污水和废料 (8)211.52 洗涤和洗设备 (8)211.56环境卫生 (9)211.58 保养 (10)D. 设备 (10)211．63 设备的设计、尺寸及位置 (10)211．65 设备制造 (10)211．67 设备清洁与保养 (11)211．68 自动化设备、机械化设备和电子设备 (12)211．72 过滤器 (13)E. 成分、药品容器和密封件的控制 (13)211．80 总要求 (13)211．82 未检验的成份、药品容器和密封件的接收与贮存 (14)211．84 成分、药品容器和封口物品的试验、批准或拒收 (14)211.86 获准的成份、药品容器和密封件的使用 (17)211.87 获准的成份、药品容器＆密封件的复检 (17)211.89 拒收的成份、药品容器＆封口物品 (17)211.94 药品密容器和密封件 (18)F. 生产和加工控制 (18)211.100 成文的规程，偏差 (18)211.101 成份的进料 (19)211.103 产量计算 (20)211.105 设备鉴别 (20)211.111 生产时间限制 (21)211.113 微生物污染的控制 (21)211.115返工 (21)G、包装和标签控制 (22)211．122材料的检查和使用标准 (22)211．125标签的发放 (23)211．130包装和标签操作 (24)211．132人用非处方药（OTC）保险包装的要求 (25)211．134药品检查 (29)211．137有效期 (29)H．贮存和销售 (30)211．150 销售程序 (30)I 实验室控制 (31)211．160 总要求 (31)211．165 销售要求的检验与发放 (32)211．166 稳定性试验 (34)211．167 特别检验要求 (35)211．170 样品保存 (36)211．173 实验动物 (38)211．176 青霉素污染 (38)J．记录和报告 (39)211．180 总要求 (39)211．182 设备清洁和使用记录 (41)211．184 成份、药品容器、密封件及标签的记录 (41)211．186 主要生产和控制的记录 (42)211．188 批生产和控制记录 (44)211．192 产品记录复查 (45)211．194 实验室记录 (45)211．196 销售记录 (47)211．198 投诉档案 (48)K．退回的药品和回收处理 (50)211．204 退回的药品 (50)211．208药品的回收处理 (51)Subpart A-General Provisions§211.1 Scopea)The regulations in this part contain theminimum current good manufacturing practice for preparation of drug products for administration to humans or animals.b)The current good manufacturing practiceregulations in this chapter, as they pertain to drug products, and in parts 600 through 680 of this chapter, as they pertain to biological products for human use, shall be considered to supplement, not supersede, the regulations in this part unless the regulations explicitly provide otherwise. In the event it is impossible to comply with applicable regulations both in this part and in other parts of this chapter or in parts 600 through 680 of this chapter, the regulation specifically applicable to the drug product in question shall supersede the regulation in this part.c)Pending consideration of a proposedexemption, published in the Federal Register of September 29, 1978, the requirements in this part shall not be enforced for OTC drug products if the products and all their ingredients are ordinarily marketed and consumed as human foods, and which products may also fall within the legal definition of drugs by virtue of their intended use. Therefore, until further notice, regulations under part 110 of this chapter, and where applicable, parts 113 to 129 of this chapter, shall be applied in determining whether these OTC drug products that are also foods are manufactured, processed, packed, or held under current good manufacturing practice.§211.3 Definitions.The definitions set forth in §210.3 of this chapter apply in this part. A．总则211．1 范围（a）本部分的条例包含人用或兽用药品制备的现行最低限度的药品生产管理规范（GMP）。
GOOD MANUFACTURE PRACTICE 美国药品生产质量管理规范（CGMP）二○○三年十二月目 录210.1 cGMP法规的地位 (2)210.2 cGMP法规的适用性 (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 (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 (14)211-J- 记录和报告 (16)211-K- 退回的药品和回收处理 (20)210部分—人用及兽用药品的生产、加工、包装或贮存的CGMP210.1 cGMP法规的地位(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) 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，同时导致该事故发生的负责人应受相应的法规的制裁。
210.2 cGMP法规的适用性(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。
210.3 定义(a) 在联邦食品、药品及化妆品法201部分中包含的定义和解释、说明适用于21CFR 211—226部分中的术语。
(b) 下面定义的术语适用于本部分及21CFR 211—226。
PART 210 CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS;GENERAL210部分有关于生产、加工、包装和药品的储存的现行GMP —般准则Sec. 210.1 Status of current good manufacturing practice regulations.(a) The regulations set forth in this part and in parts 211 through 226 of this chaptercontain 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.(b) The failure to comply with any regulationset 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 undersection 501(a) (2)(B) of the act and such drug, as well as the person who is responsible forthe failure to comply, shall be subject to regulatory action.(c) Owners and operators of establishments engaged in the recovery, donor screening, testing (including donor testing), processing, storage, labeling, packaging, or distributionof human cells, tissues, and cellular andtissue-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 applicable210.1 cGMP 的法规地位。
Guidance for IndustryQuality Systems Approach to Pharmaceutical CGMP Regulations业界指南——制药企业CGMP规范的质量体系U.S. Department of Health and Human ServicesFood and Drug AdministrationCenter for Drug Evaluation and Research (CDER)Center for Biologics Evaluation and Research (CBER)Center for Veterinary Medicine (CVM)Office of Regulatory Affairs (ORA)September 2006Pharmaceutical CGMPs目录Ⅰ简介Ⅱ背景和目的A 背景B 指南的目标C 指南适用范围D 指南的组织结构Ⅲ CGMP和现代质量系统的概念A 质量B 质量设计和产品开发C 质量风险管理D CAPA（纠偏和预防措施）E 变更控制F 质量部门G 六系统检查模式IV 质量系统模型A 管理责任1 授予领导权2 构建组织3 建立符合要求的质量系统4 建立方针政策、目标和计划5 系统审核B资源1 授予领导权2人员提高3厂房和设备4对外包工作的控制C生产制造1产品和生产工艺的设计、开发和文件化2检查输入3运作的执行和监控4 非一致性D 评估活动1 数据的趋势分析2 内部审核3 质量风险管理4 纠偏措施5 预防措施6 推动改善V 结论术语表（本指南代表了FDA对质量体系当前的思考。
它既没有为任何人也不是为赋予任何人利益而制定。
并且其操作也不对FDA或公众形成约束。
只要能够满足对现行法规和规范的要求你可以采用其它方法。
如果你有兴趣讨论其它方法，可以联系负责执行本指南的FDA人员。
如果你无法确认恰当的FDA人员，可以拨打本指南公布的电话。
PART 210 CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING，PROCESSING，PACKING, OR HOLDING OF DRUGS；GENERAL210部分有关于生产、加工、包装和药品的储存的现行GMP;一般准则Sec. 210.1 Status of current goodmanufacturing practice regulations。
210.1 cGMP的法规地位。
(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. （a）在本部分及本章第211－226部分中所陈述的法规,为现行GMP最低要求，适用于药品制造、加工、包装或贮存中所采用的方法及所使用的设施或控制手段,以保证该药品符合《联邦食品、药品及化妆品法案》（以下简称法案）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。
美国食品和药品管理局Cosmetic Good Manufacturing Practice Guidelines化妆品良好生产规范指南联邦食品、药品和化妆品法案（The Federal Food, Drug and Cosmetic Act, 以下简称FD&C 法案）禁止在州际直接贸易的化妆品是掺杂的或贴假标签的情况。
(Sec. 301)以下4种情况下，化妆品被认为是可能掺杂的：1．在用户使用过程中，由于化妆品本身含有或在包装容器中有潜在的、对人体有害的成分而使用户受到伤害的；2．本身含有不洁成分的；3．本身含有禁用成分，例如：未认可的色素添加剂；4．在不卫生条件下生产的、或保留的，可导致产品伤害用户有害或被不洁成分所污染。
以下几种情况下，化妆品被认为可能会认为贴假标签(Sec. 602)：1.虚假的标签或存在误导信息的标签2.显著违反了联邦食品、药品和化妆品法案的要求在标签上声明的信息要求3.在容器上有误导的信息为了确定化妆品生产厂家是否保留或发货了掺杂的、或是贴假标签的化妆品，和防止这些违反了FD&C 法案生产的化妆品流入市场，法律给了FDA进入这些化妆品工厂检查的权利，包括检查相关工厂的设备，成品，原料，容器和标签。
（见Sec. 704(a) of the FD&C Act.）如果工厂严格的根据良好的操作规范（GMP）的要求生产，将最低限度的减少掺杂的，或贴假标签的情况。
随后的化妆品指导，引用于FDA检查操作手册（FDA's Inspection Operations Manual），可以作为指南，用来有效的进行自我检查除。
良好的检查得分则意味着工厂执行了良好的操作规范（GMP）的要求。
指南1．建筑物和设施：检查是否a.用于生产或存放化妆品的建筑物应大小合适，设计和结构应保证设备进出不受阻碍，材料存放整洁，操作卫生以及正确的清洁和维护；b.地面，墙壁和天花板结构表面应光滑，易于清洁，并保持干净和良好状况；c.安装的固定装置，管道的滴水或者冷凝水不会污染化妆品原料，器具，以及与化妆品原料，散装产品或成品接触的设备的表面；d.照明和排风系统应满足预期员工操作和舒适的要求；e.供水，清洗和卫生设施，地面排水和废水系统应充分满足清洁操作的要求，和设备、器具的清洁要求，以及满足员工的需要并易于让员工保持个人清洁2．设备：检查是否a.加工、盛放、中转和灌装过程使用的设备和器具应设计合理，使用的材料和工艺能防止腐蚀、污垢的堆积、以及被润滑油、灰尘或者消毒剂污染；b.器具，运送管道以及和化妆品接触的设备表面应维护良好，并定期清洁和消毒；c.清洁和消毒后的便携式设备和器具应妥善放置，与化妆品接触的设备表面应罩住，以防止飞溅，灰尘或其他污染物3．员工: 检查是否a.监督化妆品的生产或者控制的员工应具有一定的教育背景，培训和/或经验来执行指定的监督工作；b.为防止化妆品掺杂，与化妆品原料，散装成品或化妆品接触表面直接接触的员工，应穿戴适合的工作服，手套，头套等，并保持良好的个人清洁；c.吃东西，喝水，或者抽烟都应严格限制在制定的区域。
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 INMANUFACTURING, PROCESSING, PACKING, OR HOLDING OFDRUGS; GENERAL210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。
目录210.1 cGMP法规的地位 (2)210.2 cGMP法规的适用性 (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 (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 (14)211-J- 记录和报告 (16)211-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(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.[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(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。
(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 through680 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.(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.Sec. 210.3 Definitions.210.3 定义(a) The definitions and interpretations contained in section 201 of the act shall be applicable to such terms when used in this part and in parts 211 through 226 of this chapter.(a) 在联邦食品、药品及化妆品法201部分中包含的定义和解释、说明适用于21CFR 211—226部分中的术语。
