美国cGMP 中英文对照版

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。

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。

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）。

新药研发一、名词解释GMP （Good Manufacturing Practice）药品生产质量管理规范GSP（Good Supply Practice）药品经营质量管理规范GAP（Good Agriculture Practice）良好药材种植规范AMP (Adenosine monophosphate)，腺嘌呤核糖核苷酸cGMP cyclic guanosine monophosphate环磷酸鸟苷GLP Good Laboratory Practice药物非临床研究质量管理规范GCP Good Clinical Practice 药品临床试验管理规范FDA Food and Drug Administration 美国食品药物管理局NDA New Drug Application 新药申请IND Investigational new drug 研发中的新药NAS New active substances 新的活性物质NOSNO nitrogen monoxide一氧化氮CO carbon monoxide一氧化碳Qbd Quality by design 设计决定质量NCE New chemical entities 新化学实体SFDA State Food and Drug Administration国家食品药品监督管理局CDE CENTER FOR DRUG EVALUATION国家食品药品监督管理局药品审评中心CP chinese pharmacopoeia中华人民共和国药典USP United States Pharmacopoeia 美国药典BE bioequivalence 生物等效性BA Bioavailability 生物利用度ADME 吸收（absorption）分布(distribution) 代谢(metabolism) 排泄(excretion) CFR Case report form 病例报告表DMF Drug Master File 药品主文件EDMF European Drug Master File欧盟药品主文件CTD Common Technical Document国际注册用常规技术文件COS（Certificate of Suitability）欧洲药典适应性认证CEP（Certificate of Suitability of Ph Eur）欧洲药典适用性认证Pharmacodynamics（药效学）pharmacokinetics（药动学）adverse reaction（不良反应HTS (High-throughput screening) 高通量筛选药物靶点是指药物在体内的作用结合位点，包括基因位点、受体、酶、离子通道、核酸等生物大分子。

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。

[Code of Federal Regulations][Title 21, Volume 2][Revised as of April 1, 2015][CITE: 21CFR111]TITLE 21--FOOD AND DRUGSCHAPTER I--FOOD AND DRUG ADMINISTRATIONDEPARTMENT OF HEALTH AND HUMAN SERVICESSUBCHAPTER B--FOOD FOR HUMAN CONSUMPTIONPART 111 CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS 第111部分饮食添加剂生产、包装、标签和储藏操作的CGMP规范Subpart A--General Provisions一般规定Sec. 111.1 Who is subject to this part?这部分的主要内容是什么？(a) Except as provided by paragraph (b) of this section, you are subject to this part if you manufacture, package, label, or hold a dietary supplement, including:除了b节中规定的以外，生产、包装、贴标或保存膳食补充剂都受到这个规范的支配，包括：(1) A dietary supplement you manufacture but that is packaged or labeled by another person; and一个生产商生产的膳食补充剂，却由另一个进行包装或贴标；(2) A dietary supplement imported or offered for import in any State or territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico.出口到任何国家或美国地区，哥伦比亚特区，或波多黎各自由邦的膳食补充剂(b) The requirements pertaining to holding dietary supplements do not apply to you if you are holding those dietary supplements at a retail establishment for the sole purpose of direct retail sale to individual consumers. A retail establishment does not include a warehouse or other storage facility for a retailer or a warehouse or other storage facility that sells directly to individual consumers.若这些膳食补充剂在零售店唯一的目的是零售给个人消费者，则控制膳食补充剂的有关需求不适用。

Subpart A-General Provisions§211.1 Scopea)The regulations in this part contain the minimumcurrent good manufacturing practice for preparation of drug products for administration to humans or animals.b)The current good manufacturing practice regulationsin 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 proposed exemption,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。