美国cGMP-中英文对照

PART 210 CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL 210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 good

manufacturing 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。

(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 (c)人类细胞、组织和细胞组织底物产品

（HCT/Ps），根据本章§1271.3(d)的定义属药品（按照《法案》第505节递交的申请或按照《公共健康服务法案》第351节进行的生物制品许可申请接受审核），从事该类药品回收、捐献者筛选、检验（包括捐献者检验）、加工、贮藏、贴标、包装或销售企业的所有者和经营者，除受本部分法规及21CFR第211－226部分约束外，还应受本章第1271部分的C子部分和D子部分陈述的捐献者合格性和适用的《现行良好组织操作规程》的约束。在药品制造、加工、包装或贮存过程中，如存在不符合本部分及21CFR第211—226部分、21CFR第1271部分的C子部分或21CFR第1271部分的D子部分中任何法规的情况，依据《法案》第501节(a)(2)(B)，将该HCT/P视为劣药，并且对该HCT/P及事故责任人采取相应监管措施。

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.

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21CFR211-226适用于普通药品，21CFR 600-680适用于人用生物制品，21CFR 1271部分适用于人类的细胞、组织或是细胞组织底物产品(HCT/P) 类药品（按照《法案》第505节递交的申请或按照《公共健康服务法案》第351节进行的生物制品许可申请接受审核），它们之间应该是相互补充而不是相互取代，法规另有明确规定除外。在适用本部分法规和

21CFR其它部分法规发生冲突的情况下，特别法规应替代普通法规适用于所涉及的药品。

(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. (b)如果一个人的具体操作仅涉及到21CFR中的本部分，211到226部分，600到680部分和1271部分，而不参与到其他部分中，这个人仅仅需要遵守他/她所涉及的相关操作的规范。

(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 (c)在21CFR 312.21(a)部分描述的要调查的第一阶段研究的药品要服从在21 U.S.C.

51(a)(2)(B)中陈述的法规要求。这种药物的生产可以免除21CFR第211部分法规的要求。然而，一旦这个要调研的新药可以被申请者应用

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. 到第二，三阶段的研究中，如本章中

312.21(b)&(c)描述的那样，或是药品已经合法上市，那前面所述的第一阶段的一个要调研用药并不适用于免除。如果调研用药已经在第二阶段和第三阶段中应用或是药品已经合法上市了，那么药品的第一阶段的研究必须遵守211部分的要求。

[69 FR 29828, May 25, 2004, as amended at

73 FR 40462, July 15, 2008]

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、说明适用于部分及21CFR 211—226部分中的术语。

(b) The following definitions of terms apply to this part and to parts 211 through 226 of this chapter. (b)下面术语的定义同样适用于本部分及21CFR 211—226部分中的术语

(1) Act means the Federal Food, Drug, and Cosmetic Act, as amended (21 U.S.C. 301et seq.). （1）法案

指联邦食品、药品及化妆品法，修订版(21 U.S.C 301 et seq.)。

(2) Batch means a specific quantity of a drug or other material that is intended to have uniform character and quality, within specified limits, and is produced according to a single manufacturing order during the same cycle of manufacture. （2）批

指在规定限度内，按照某一生产指令在同一生产周期内生产出来的，具有同一性质和质量的一定数量的药品或其它物料。

(3) Component means any ingredient intended for use in the manufacture of a drug product, including those that may not appear in such drug product. （3）组份

指用于药品生产过程中的所有成份，包括那些未在药品中出现的成份。

(4) Drug product means a finished dosage form, for example, tablet, capsule, solution, etc., that contains an active drug ingredient （4）药品

指成品制剂(如：片剂、胶囊剂、溶液等)，通常含有一种活性成份并伴有非活性成份(但不是必

generally, but not necessarily, in association with inactive ingredients. The term also includes a finished dosage form that does not contain an active ingredient but is intended to be used as a placebo. 需的)。本术语也包括不含有活性成份但作为安慰剂使用的成品制剂。

(5) Fiber means any particulate contaminant with a length at least three times greater than its width. （5）纤维

指长度大于其宽度的3倍的任何微粒状污染物。

(6) Non fiber releasing filter means any filter, which after appropriate pretreatment such as washing or flushing, will not release fibers into the component or drug product that is being filtered. （6）无纤维脱落过滤器

指任何经过适当的预处理(如清洗或冲洗)后，不会将纤维脱落到已过滤的组份或药品中的过滤器。

(7) Active ingredient means any component that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of man or other animals. The term includes those components that may undergo chemical change in the manufacture of the drug product and be present in the drug product in a modified form intended to furnish the specified activity or effect. （7）活性成份

是指任何具有药物活性或其他在疾病的诊断、治愈、缓解、治疗或预防中起直接作用，或影响人或其他动物身体结构或功能的组份。本术语包括那些在药品制造中发生化学变化并为了发挥其特定的活性或疗效而以一种修饰形式存在于药品中的组份。

(8) Inactive ingredient means any component other than an active ingredient.（8）非活性成份

指不同于“活性成份”的其他任何组份。

(9) In-process material means any material fabricated, compounded, blended, or derived by chemical reaction that is produced for, and used in, the preparation of the drug product. （9）中间体

是指所有经制备、化合、混合或经由化学反应得到的用于药品生产的物料。

(10) Lot means a batch, or a specific identified portion of a batch, having uniform character and quality within specified limits; or, in the case of a drug product produced by continuous process, it is a specific identified amount produced in a unit of time or quantity in a manner that assures its having uniform character and quality within specified limits. （10）批

指一批或是一批中特定的均一部分，在指定的范围内具有相同的性质和质量；或者若为由连续的生产过程制造出的药品，“批”指在单位时间或单位数量生产出的特定的、均一的部分，并且确保该部分在指定的范围内具有均一的性质和质量。

(11) Lot number, control number, or batch number means any distinctive combination of （11）批号

指由字母、数字、符号或他们的组合构成，由

letters, numbers, or symbols, or any combination of them, from which the complete history of the manufacture, processing, packing, holding, and distribution of a batch or lot of drug product or other material can be determined. 此可确定某批药品或物料的生产、加工、包装、贮存或销售的情况。

(12) Manufacture, processing, packing, or holding of a drug product includes packaging and labeling operations, testing, and quality control of drug products. （12）药品的生产、加工、包装或贮存

包括药品的包装和标签操作、检验、质量控制。

(13) The term medicated feed means any Type B or Type C medicated feed as defined in 558.3 of this chapter. The feed contains one or more drugs as defined in section 201(g) of the act. The manufacture of medicated feeds is subject to the requirements of part 225 of this chapter. （13）药用物料

指在21CFR 558.3中定义的B型和C型药用物料。该物料含有联邦食品、药品及化妆品法201(g)部分中定义的一种或一种以上的药物，药用物料的生产应符合21CFR 225部分中的要求。

(14) The term medicated premix means a Type A medicated article as defined in 558.3 of this chapter. The article contains one or more drugs as defined in section 201(g) of the act. The manufacture of medicated premixes is subject to the requirements of part 226 of this chapter. （14）药用预混合料

指21CFR 558.3中定义的A型药用物料。该预混合料含有联邦食品、药品及化妆品法201(g)部分中定义的一种或一种以上的药物。药用预混合料生产应符合21CFR 226部分中的要求。

(15) Quality control unit means any person or organizational element designated by the firm to be responsible for the duties relating to quality control. （15）质量控制部门

指由企业任命负责质量控制相关责任的任何人员或组织机构。

(16) Strength means:

(i) The concentration of the drug substance (for example, weight/weight, weight/volume, or unit dose/volume basis), and/or

(ii) The potency, that is, the therapeutic activity of the drug product as indicated by appropriate laboratory tests or by adequately developed and controlled clinical data (expressed, for example, in terms of units by reference to a standard). （16）规格

(Ⅰ) 原料药的浓度(如：以重量/重量、重量/体积、单位剂量/体积为基础)；和/(或)

(Ⅱ) 活性(效价)即根据适当的实验室检测或足够的临床研究可靠数据而得出的药品治疗活性(例如可表达为相当于多少单位的标准物质)。

(17) Theoretical yield means the quantity that would be produced at any appropriate phase （17）理论产量

指在生产、加工或包装某种药品的任一适当阶

of manufacture, processing, or packing of a particular drug product, based upon the quantity of components to be used, in the absence of any loss or error in actual production. 段中，并且基于所使用的组份的数量在实际生产中无任何损失或错误的情况下，应能生产的数量。

(18) Actual yield means the quantity that is actually produced at any appropriate phase of manufacture, processing, or packing of a particular drug product. （18）实际产量

指某种药品在生产、加工、包装的任一适当的阶段实际生产出的数量。

(19) Percentage of theoretical yield means the ratio of the actual yield (at any appropriate phase of manufacture, processing, or packing of a particular drug product) to the theoretical yield (at the same phase), stated as a percentage. （19）理论收率（我们认为是实际收率）

指生产、加工或包装某种药品的任一适当阶段的实际产量与该阶段理论产量的比率，以百分数表示。

(20) Acceptance criteria means the product specifications and acceptance/rejection criteria, such as acceptable quality level and unacceptable quality level, with an associated sampling plan, that are necessary for making a decision to accept or reject a lot or batch (or any other convenient subgroups of manufactured units). （20）接受标准

指与取样检验方法相联系的产品标准和接受/拒绝标准，诸如可接受的质量水平及不可接受的质量水平，这是对一批或一整批（或其它产出单元中方便表示的亚批）做出接受或拒绝的必要依据。

(21) Representative sample means a sample that consists of a number of units that are drawn based on rational criteria such as random sampling and intended to assure that the sample accurately portrays the material being sampled. （21）代表性样品

指一个样品包含若干单位按合理的标准抽取（如随机取样法），以能保证取到样品有代表性。

(22) Gang-printed labeling means labeling derived from a sheet of material on which more than one item of labeling is printed. （22）联合印刷的贴签

指从物料表所演变来的贴标，上面印刷有一个以上的条目。

[43 FR 45076, Sept. 29, 1978, as amended at 51 FR 7389, Mar. 3, 1986; 58 FR 41353, Aug. 3, 1993; 73 FR 51931, Sept. 8, 2008]

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION

DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER C--DRUGS: GENERAL

PART 211 CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED

PHARMACEUTICALS

211部分对于成品制剂的现行GMP

Subpart A--General Provisions § 211.1 - Scope. 范围

§ 211.3 - Definitions. 定义A. 总则

§211.1 范围§211.3 定义

Subpart B--Organization and Personnel

§ 211.22 - Responsibilities of quality control unit. § 211.25 - Personnel qualifications.

§ 211.28 - Personnel responsibilities.

§ 211.34 - Consultants. B. 组织机构和人员

§211.22质量控制部门的职责§211.25人员资质

§211.28人员职责

§211.34顾问

Subpart C--Buildings and Facilities

§ 211.42 - Design and construction features. § 211.44 - Lighting.

§ 211.46 - Ventilation, air filtration, air heating and cooling.

§ 211.48 - Plumbing.

§ 211.50 - Sewage and refuse.

§ 211.52 - Washing and toilet facilities.

§ 211.56 - Sanitation.

§ 211.58 - Maintenance. C. 建筑和设施

§ 211.42设计与建造特征

§ 211.44照明

§ 211.46通风、空气过滤、空气加热与冷却

§ 211.48管件

§ 211.50污水和废料

§ 211.52洗涤和盥洗设施

§ 211.56卫生

§ 211.58保养

Subpart D--Equipment设备

§ 211.63 - Equipment design, size, and location. § 211.65 - Equipment construction.

§ 211.67 - Equipment cleaning and maintenance. § 211.68 - Automatic, mechanical, and electronic equipment.

§ 211.72 - Filters. D. 设备

§ 211.63 设备的设计、尺寸及位置§ 211.65 设备的建造

§ 211.67 设备的清洁和维护

§ 211.68 自动化、机械化和电子设备§ 211.72 过滤器

Subpart E--Control of Components and Drug Product Containers and Closures

§ 211.80 - General requirements.

§ 211.82 - Receipt and storage of untested E. 组份、药品容器和密封器控制

§ 211.80 总体要求

§ 211.82 未检验的组份、药品容器和密封器的接收与贮存

[Code of Federal Regulations] [Title 21, Volume 4] [Revised as of April 1, 2009] [CITE: 21CFR211]

components, drug product containers, and closures.

§ 211.84 - Testing and approval or rejection of components, drug product containers, and closures.

§ 211.86 - Use of approved components, drug product containers, and closures.

§ 211.87 - Retesting of approved components, drug product containers, and closures.

§ 211.89 - Rejected components, drug product containers, and closures.

§ 211.94 - Drug product containers and closures. § 211.84 组份、药品容器和密封器的检测、批准或拒收

§ 211.86 批准后组份，药物容器和密封器的使用

§ 211.87 组份、药品容器和密封器的复检. § 211.89 拒收的组份、药品容器和密封器§ 211.94 药品容器和密封器

Subpart F--Production and Process Controls § 211.100 - Written procedures; deviations.

§ 211.101 - Charge-in of components.

§ 211.103 - Calculation of yield.

§ 211.105 - Equipment identification.

§ 211.110 - Sampling and testing of in-process materials and drug products.

§ 211.111 - Time limitations on production.

§ 211.113 - Control of microbiological contamination.

§ 211.115 - Reprocessing. F. 生产和加工控制

§ 211.100 成文的规程、偏差

§ 211.101 组份的进料

§ 211.103产量计算

§ 211.105设备标识

§ 211.110中间体和成品的取样与检验§ 211.111生产时间限制

§ 211.113微生物污染的控制

§ 211.115返工

Subpart G--Packaging and Labeling Control § 211.122 - Materials examination and usage criteria.

§ 211.125 - Labeling issuance.

§ 211.130 - Packaging and labeling operations. § 211.132 - Tamper-evident packaging requirements for over-the-counter (OTC) human drug products.

§ 211.134 - Drug product inspection.

§ 211.137 - Expiration dating. G. 包装和标签控制

§ 211.122物料的检查和使用标准

§ 211.125标签的发放

§ 211.130包装和贴签操作

§ 211.132人用非处方药（OTC）保险包装的要求

§ 211.134药品检查

§ 211.137有效期

Subpart H--Holding and Distribution § 211.142 - Warehousing procedures. § 211.150 - Distribution procedures. H. 贮存和销售

§ 211.142入库程序§ 211.150 销售程序

Subpart I--Laboratory Controls

§ 211.160 - General requirements.

§ 211.165 - Testing and release for distribution. § 211.166 - Stability testing.

§ 211.167 - Special testing requirements.

§ 211.170 - Reserve samples. I. 实验室控制

§ 211.160总体要求

§ 211.165销售的检验与放行§ 211.166稳定性实验

§ 211.167特别检验要求

§ 211.170留样

§ 211.173 - Laboratory animals.

§ 211.176 - Penicillin contamination. § 211.173实验动物§ 211.176青霉素污染

Subpart J--Records and Reports

§ 211.180 - General requirements.

§ 211.182 - Equipment cleaning and use log.

§ 211.184 - Component, drug product container, closure, and labeling records.

§ 211.186 - Master production and control records.

§ 211.188 - Batch production and control records. § 211.192 - Production record review.

§ 211.194 - Laboratory records.

§ 211.196 - Distribution records.

§ 211.198 - Complaint files. J. 记录和报告

§ 211.180总体要求

§ 211.182设备清洁和台帐

§ 211.184组份、药品容器、密封器及标签记录

§ 211.186主生产和控制的记录

§ 211.188批生产和控制记录

§ 211.192生产记录审核

§ 211.194实验记录

§ 211.196销售记录

§ 211.198投诉档案

Subpart K--Returned and Salvaged Drug Products

§ 211.204 - Returned drug products.

§ 211.208 - Drug product salvaging. K. 药品的退回和再利用§ 211.204药品的退回§ 211.208药品的再利用

PART 211 CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED

PHARMACEUTICALS

Subpart A--General Provisions A——总则

Sec. 211.1 Scope. 211.1范围

(a) The regulations in this part contain the minimum current good manufacturing practice for preparation of drug products for administration to humans or animals. （a）本部分的条例包含人用或兽用药品制备的最低限度的现行药品生产质量管理规范（GMP）

(b) The current good manufacturing practice regulations in this chapter as they pertain to drug products; in parts 600 through 680 of this chapter, as they pertain to drugs that are also biological products for human use; and in part 1271 of this chapter, as they are applicable to drugs that are also human cells, tissues, and cellular and tissue-based products (HCT/Ps) and 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); supplement and do not supersede the regulations in this part 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, or in parts 600 through 680 of this chapter, or in part 1271 of this chapter, the regulation specifically applicable to the drug product in question shall supersede the more general. （b）在21CFR里的这些针对普通药品的现行GMP条例和21CFR 600至680的所有部分针对人用生物制品的现行GMP条例，在21CFR 的1271部分中，法规适用于人类细胞，组织和细胞组织为底物的产品（HCT/Ps）和一些药品，这些药品（符合《法案》505部分的关于提交申请的审核部分或是《公共健康服务法案》351部分的生物产品申请许可）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。在21CFR的这部分和其他部分，或者是在21CFR的600到680的部分，或是1271部分法规有发生冲突的情况下，则可用存在争议药品的特定具体的法规来替代一般性的。

(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 （c）在考虑经提议的，发表在1978年9月29日联邦注册表（FR）上的一个免除项是，若产品及其所有成份是以人用食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。21CFR 110部分和113至119部分的条例用于鉴别这些OTC药品是否按照GMP的要求生产、加工、包装和贮存。

foods are manufactured, processed, packed, or

held under current good manufacturing

practice.

Sec. 211.3 Definitions 211.3定义

The definitions set forth in 210.3 of this chapter

apply in this part.

21CFR 210?3中解释的定义适用于本部分

Subpart B--Organization and Personnel B——组织机构和人员

Sec. 211.22 Responsibilities of quality control

unit.

211.22质量控制部门的职责

(a) There shall be a quality control unit that shall have the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging material, labeling, and drug products, and the authority to review production records to assure that no errors have occurred or, if errors have occurred, that they have been fully investigated. The quality control unit shall be responsible for approving or rejecting drug products manufactured, processed, packed, or held under contract by another company. （a）需建立质量控制部门，本部门有批准和拒收所有组份、药品包装容器、密封器、中间体、包装材料、标签及药品的职责与权力，审核生产记录的权力，保证不产生差错，或若发生差错，保证他们充分调查。本部门负责根据合同，批准或拒收由其它公司生产、加工、包装或贮存的药品。

(b) Adequate laboratory facilities for the testing and approval (or rejection) of components, drug product containers, closures, packaging materials, in-process materials, and drug products shall be available to the quality control unit. （b）质量控制部门要可以获得足够的实验室设备用于检验和批准（或拒收）各种组份、药品容器、密封器、包装材料及中间体。

(c) The quality control unit shall have the responsibility for approving or rejecting all procedures or specifications impacting on the identity, strength, quality, and purity of the drug product. （c）本部门有批准或驳回影响药品的均一性、规格、质量和纯度的所有程序或质量标准的职责。

(d) The responsibilities and procedures applicable to the quality control unit shall be in writing; such written procedures shall be followed. （d）适用于本部门的职责与程序，应成文件，并应遵循执行。

Sec. 211.25 Personnel qualifications. 211.25人员资质

(a) Each person engaged in the manufacture, processing, packing, or holding of a drug product shall have education, training, and experience, or any combination thereof, to (a)每位从事药品生产、加工、包装或储存工作人员，应接受培训、教育及有实践经验，完成委派的各项任务。培训是按照现行GMP（包括21-CFR 211部分中的现行GMP条例和这些条

enable that person to perform the assigned functions. Training shall be in the particular operations that the employee performs and in current good manufacturing practice (including the current good manufacturing practice regulations in this chapter and written procedures required by these regulations) as they relate to the employee's functions. Training in current good manufacturing practice shall be conducted by qualified individuals on a continuing basis and with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them. 例要求的文件）中涉及员工的职能。邀请有资质的人员指导，并连续多次培训，保证员工熟悉现行GMP对他们的要求。

(b) Each person responsible for supervising the manufacture, processing, packing, or holding of a drug product shall have the education, training, and experience, or any combination thereof, to perform assigned functions in such a manner as to provide assurance that the drug product has the safety, identity, strength, quality, and purity that it purports or is represented to possess. (b)负责监督药品的生产、加工、包装或储存工作的每一个工作人员，应受教育、培训及有经验，来完成委派的各项任务。以此作为提供药品具有安全性、均一性、规格、质量及纯度的保证。

(c) There shall be an adequate number of qualified personnel to perform and supervise the manufacture, processing, packing, or holding of each drug product. （c）有足够人数的合格员工进行和监督每种药品的生产、加工、包装或储存。

Sec. 211.28 Personnel responsibilities. 211.28人员职责

(a) Personnel engaged in the manufacture, processing, packing, or holding of a drug product shall wear clean clothing appropriate for the duties they perform. Protective apparel, such as head, face, hand, and arm coverings, shall be worn as necessary to protect drug products from contamination. （a）从事药品生产、加工、包装或储存的人员，应穿着适合于其工作的清洁服装。必要时应佩戴保护性用品，如头部、脸部、手部、臂部要戴上遮护用品，防止药物受污染。

(b) Personnel shall practice good sanitation

and health habits.

(b)人员要保持良好的个人卫生和健康习惯。

(c) Only personnel authorized by supervisory personnel shall enter those areas of the buildings and facilities designated as limited-access areas. (c)只有经监督人员授权的人员才可以进入建筑物和设施的限制区域。

(d) Any person shown at any time (either by medical examination or supervisory observation) to have an apparent illness or open lesions that may adversely affect the safety or quality of drug products shall be （d）任何人，在任何时间（无论是通过医学检查或是监控观察），患有危及药品安全性和质量的疾病或开放性损伤，都应避免接触各种组份、药品容器、包装设备、密封器、中间体和最终产品，直至健康状况已恢复或是有资格的医学

excluded from direct contact with components, drug product containers, closures, in-process materials, and drug products until the condition is corrected or determined by competent medical personnel not to jeopardize the safety or quality of drug products. All personnel shall be instructed to report to supervisory personnel any health conditions that may have an adverse effect on drug products. 人员确认该员工不会对药品安全性和质量有危害。所有的人员都要被告知如果发生任何可能对药品产生不良影响的健康状况，都要向相关的监管人员报告。

Sec. 211.34 Consultants. 211.34 顾问

Consultants advising on the manufacture, processing, packing, or holding of drug products shall have sufficient education, training, and experience, or any combination thereof, to advise on the subject for which they are retained. Records shall be maintained stating the name, address, and qualifications of any consultants and the type of service they provide. 顾问应对药品生产、加工、包装或储存提出建议，他们要受过足够的教育、培训，且有丰富的实践经验，来对他们在行的领域问题提出建议。顾问的姓名、地址、资格证明及所提供服务形式等资料要保存。

Subpart C--Buildings and Facilities C——建筑和设施Sec. 211.42 Design and construction features. 211.42设计与建造特征

(a) Any building or buildings used in the manufacture, processing, packing, or holding of a drug product shall be of suitable size, construction and location to facilitate cleaning, maintenance, and proper operations. (a)任何用于某类药品生产、加工、包装或储存的厂房或建筑群，大小要适宜，结构与选址要使其易于清洁、保养、适合操作。

(b) Any such building shall have adequate space for the orderly placement of equipment and materials to prevent mixups between different components, drug product containers, closures, labeling, in-process materials, or drug products, and to prevent contamination. The flow of components, drug product containers, closures, labeling, in-process materials, and drug products through the building or buildings shall be designed to prevent contamination. (b)建筑物有足够空间来有条理地摆放设备和物料，避免不同类的组份、药品容器、密封器、标签、中间体或药品等相互混放，防止污染。通过厂房的上述物料其流向在设计时要防止污染。

(c) Operations shall be performed within specifically defined areas of adequate size. There shall be separate or defined areas or such other control systems for the firm's operations as are necessary to prevent contamination or mixups during the course of the following procedures: (c)操作应在明确规定的、大小适中的区域内进行。在下列操作过程中，操作要分开，在特定的区域或其他控制系统中进行，这个对于防止污染或是混淆是必要的。

(1) Receipt, identification, storage, and withholding from use of components, drug (1)放行给生产或包装前，由质量控制部门取样、检测和检查期间，药品的组份、容器、密封器

product containers, closures, and labeling,

pending the appropriate sampling, testing, or

examination by the quality control unit before

release for manufacturing or packaging;

及标签，监督接收、鉴别、储存及拒收过程：

(2) Holding rejected components, drug product containers, closures, and labeling before disposition; (2)拒收组份、药品容器、密封器及标签处理前的储存过程；

(3) Storage of released components, drug product containers, closures, and labeling; (3)已放行的组份、药品容器、密封器及标签的储存；

(4) Storage of in-process materials; (4)中间体的储存；

(5) Manufacturing and processing operations; (5)生产与加工操作；

(6) Packaging and labeling operations; (6)包装和贴标签操作；

(7) Quarantine storage before release of drug

products;

(7)药品放行前的待验隔离储存；

(8) Storage of drug products after release; (8)放行后药品的储存；

(9) Control and laboratory operations; (9)控制与实验室的操作；

(10) Aseptic processing, which includes as

appropriate:

(10)无菌操作过程，包括如下适宜的操作；

(i) Floors, walls, and ceilings of smooth, hard surfaces that are easily cleanable; (i)地板、墙壁和天花板平滑、坚硬、表面易清洁；

(ii) Temperature and humidity controls; (ii)温度与湿度控制；

(iii) An air supply filtered through high-efficiency particulate air filters under positive pressure, regardless of whether flow is laminar or nonlaminar ; (iii)不管是层流或非层流，空气在正压下经高效过滤器过滤；

(iv) A system for monitoring environmental

conditions;

(iv)环境监测系统；

(v) A system for cleaning and disinfecting the room and equipment to produce aseptic conditions; (v)用来创造无菌条件的房间和设备清洁、消毒的系统；

(vi) A system for maintaining any equipment

used to control the aseptic conditions.

(vi)用来控制无菌环境的设备维修的系统；

(d) Operations relating to the manufacture, processing, and packing of penicillin shall be performed in facilities separate from those used for other drug products for human use. (d)青霉素生产、加工及包装的操作所用设备与生产其他人用药品的设备分开；

[43 FR 45077, Sept. 29, 1978, as amended at

60 FR 4091, Jan. 20, 1995]

Sec. 211.44 Lighting 211.44照明.

Adequate lighting shall be provided in all

areas.

所有区域均须提供充足的照明

Sec. 211.46 Ventilation, air filtration, air

heating and cooling.

211.46通风、空气过滤、空气加热及冷却(a) Adequate ventilation shall be provided. (a)应提供足够的通风

(b) Equipment for adequate control over air pressure, micro-organisms, dust, humidity, and temperature shall be provided when appropriate for the manufacture, processing, packing, or holding of a drug product. (b)提供足以控制空气压力、微生物、灰尘、温度和湿度的设备，来适应药品生产、加工、包装和储存需要。

(c) Air filtration systems, including prefilters and particulate matter air filters, shall be used when appropriate on air supplies to production areas. If air is recirculated to production areas, measures shall be taken to control recirculation of dust from production. In areas where air contamination occurs during production, there shall be adequate exhaust systems or other systems adequate to control contaminants. (c)适当的时候，应对输送至生产区域的空气使用空气过滤系统，该系统包括预过滤器和微粒物质空气过滤器。如果空气再循环到生产区，应采取措施控制来自生产的灰尘循环。在生产过程中有空气污染的区域，应该有充足的排风系统或其他系统来控制污染。

(d) Air-handling systems for the manufacture, processing, and packing of penicillin shall be completely separate from those for other drug products for human use. (d)青霉素生产、加工和包装的空调系统应与其他人用药品的空调系统完全分开。

Sec. 211.48 Plumbing. 211.48管件

(a) Potable water shall be supplied under continuous positive pressure in a plumbing system free of defects that could contribute contamination to any drug product. Potable water shall meet the standards prescribed in the Environmental Protection Agency's Primary Drinking Water Regulations set forth in 40 CFR part 141. Water not meeting such standards shall not be permitted in the potable water system. (a)饮用水应在持续正压，对药品无污染的管道系统内供应，这个管道系统内应没有可能导致药品污染的缺陷。饮用水应符合环境保护机构制订的“基本饮用水条例”标准（40CFR141部分）。不符合该标准的水，不许进入饮用水系统。

(b) Drains shall be of adequate size and, where connected directly to a sewer, shall be provided with an air break or other mechanical device to prevent back-siphonage. (b) 排水设备应有足够的大小，在直接连接至下水道的地方应该提供空断或其他机械设备以防止发生倒虹吸。

[43 FR 45077, Sept. 29, 1978, as amended at

48 FR 11426, Mar. 18, 1983]

Sec. 211.50 Sewage and refuse. 211.50污水和废料

Sewage, trash, and other refuse in and from the building and immediate premises shall be disposed of in a safe and sanitary manner. 进入和流出建筑物和附近区域的污水、垃圾及其他废物应用安全、卫生的方法处理。

Sec. 211.52 Washing and toilet facilities 211.52洗涤和盥洗设备

Adequate washing facilities shall be provided, including hot and cold water, soap or detergent, air driers or single-service towels, and clean toilet facilities easily accesible to working areas. 提供足够的洗涤和盥洗设备，包括冷热水、肥皂或清洁剂、空气干燥器或是专用毛巾和干净的盥洗设备，以便进入工作区域。

Sec. 211.56 Sanitation. 211.56卫生

(a) Any building used in the manufacture, processing, packing, or holding of a drug product shall be maintained in a clean and sanitary condition, Any such building shall be free of infestation by rodents, birds, insects, and other vermin (other than laboratory animals). Trash and organic waste matter shall be held and disposed of in a timely and sanitary manner. (a)用于药品生产、加工、包装及储存的建筑应保持清洁、卫生的环境，这种建筑不能有啮齿动物、鸟类、昆虫及其他害虫侵害（实验动物除外）。垃圾和有机废料要及时采用对环境无危害的方法处理。

(b) There shall be written procedures assigning responsibility for sanitation and describing in sufficient detail the cleaning schedules, methods, equipment, and materials to be used in cleaning the buildings and facilities; such written procedures shall be followed. (b)制定并执行程序来分配清洁职责，详细描述清洁计划、方法、设备、清洁厂房和设施的材料。

(c) There shall be written procedures for use of suitable rodenticides, insecticides, fungicides, fumigating agents, and cleaning and sanitizing agents. Such written procedures shall be designed to prevent the contamination of equipment, components, drug product containers, closures, packaging, labeling materials, or drug products and shall be followed. Rodenticides, insecticides, and fungicides shall not be used unless registered and used in accordance with the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 135). (c)制定并执行程序来规定适用的灭鼠剂、杀虫剂、杀真菌剂、熏蒸剂、去垢剂和消毒剂应用的操作过程。本程序设计是防止这些物品对设备、组份、药品容器、密封器、包装材料、标签或药品产生污染。除依据联邦灭鼠剂、杀虫剂、杀真菌剂法规（7U.S.C135）已登记和使用的品种外，其他的杀虫剂、杀真菌剂及杀鼠剂不能使用。

(d) Sanitation procedures shall apply to work performed by contractors or temporary employees as well as work performed by full-time employees during the ordinary course of operations. (d)卫生程序要在合同工和临时工的工作中执行，同时也要在全职工作人员日常操作中执行。

Sec. 211.58 Maintenance. 211.58保养

Any building used in the manufacture, processing, packing, or holding of a drug product shall be maintained in a good state of repair. 任何用于药品生产、加工、包装或储存的建筑应处于一种保持良好的保养状态。

Subpart D--Equipment D--设备

Sec. 211.63 Equipment design, size, and

location.

211.63设备的设计、尺寸及位置

Equipment used in the manufacture, processing, packing, or holding of a drug product shall be of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its 药品生产、加工、包装或储存中使用的设备，应设计合理，大小适当，布置合理，便于操作、清洁和保养。

cleaning and maintenance.

Sec. 211.65 Equipment construction. 211.65设备制造

(a) Equipment shall be constructed so that surfaces that contact components, in-process materials, or drug products shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements. (a)与各种中间体材料或药品成品接触的设备表面，不反应、不脱落、不吸附从而改变药品的安全性、均一性、效价或含量、质量或纯度超出官方或其他设定的要求。

(b) Any substances required for operation, such as lubricants or coolants, shall not come into contact with components, drug product containers, closures, in-process materials, or drug products so as to alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements. (b)操作所需的物质，如润滑剂或是冷却剂等不能接触组份、药品容器、密封器、中间体或成品，从而改变药品的安全性、均一性、效价或含量、质量或纯度超出官方或其他设定的要求。

Sec. 211.67 Equipment cleaning and

maintenance.

211.67设备清洁与保养

(a) Equipment and utensils shall be cleaned, maintained, and, as appropriate for the nature of the drug, sanitized and/or sterilized at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements. (a)定期对设备与工具进行清洁和保养，根据药品的特性，还要进行消毒和灭菌，防止出故障与受污染，从而改变药品的安全性、均一性、效价或含量、质量或纯度，超出官方和其他设立的要求。

(b) Written procedures shall be established and followed for cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing, or holding of a drug product. These procedures shall include, but are not necessarily limited to, the following: (b)应对药品生产、加工、包装或储存中使用的设备，包括工具制订并执行清洁和保养的程序。这些程序包括，但不限于以下内容：

Sec. 211.68 Automatic, mechanical, and

electronic equipment.

211.68 自动化、机械化和电子设备Sec. 211.72 Filters. 211.72 过滤器

Filters for liquid filtration used in the manufacture, processing, or packing of injectable drug products intended for human use shall not release fibers into such products. Fiber-releasing filters may be used when it is not possible to manufacture such products without the use of these filters. If use of a 人用注射药品生产、加工或包装过程中使用到的液体过滤器的不能向产品中释放纤维。除非这种产品没有这种过滤器就不能生产，若必须使用这种可能释放纤维素的过滤器，则应用另外一种不释放纤维物，最大孔径为0.22μm(如实际生产条件限制，可用0.45μm)的附加过滤器过滤，降低注射剂内微粒量。禁止使用含石

fiber-releasing filter is necessary, an additional

nonfiber-releasing filter having a maximum

nominal pore size rating of 0.22 micron (0.45

micron if the manufacturing conditions so

dictate) shall subsequently be used to reduce

the content of particles in the injectable drug

product. The use of an asbestos-containing

filter is prohibited.

[73 FR 51932, Sept. 8, 2008]

棉的过滤器。

Subpart E--Control of Components and

Drug Product Containers and Closures

E--组份、药品容器和密封器的控制

(a) There shall be written procedures describing in sufficient detail the receipt, identification, storage, handling, sampling, testing, and approval or rejection of components and drug product containers and closures; such written procedures shall be followed. (a)制定详细说明组份、药品容器、密封器的接收、鉴别、储存、处理、取样、检验和批准或拒收的程序并遵照执行。

Sec. 211.80 General requirements. 211.80总体要求

(b) Components and drug product containers and closures shall at all times be handled and stored in a manner to prevent contamination. (b)组份、药品容器和密封器应一直在无污染的环境下储存和管理。

(c) Bagged or boxed components of drug product containers, or closures shall be stored off the floor and suitably spaced to permit cleaning and inspection. (c)药品容器的包装袋或包装箱或密封器应离地面放置，并保持适当距离，以便清洁和检查。

(d) Each container or grouping of containers for components or drug product containers, or closures shall be identified with a distinctive code for each lot in each shipment received. This code shall be used in recording the disposition of each lot. Each lot shall be appropriately identified as to its status (i.e., quarantined, approved, or rejected). (d)接收的每一个或是一组盛装组份的容器都要用明显的批号代码编码。此代码用于记录每批货的分发情况。每一批都应有状态标识（如隔离、批准或拒收）。

Sec. 211.82 Receipt and storage of untested components, drug product containers, and closures. 211.82 待检的组份、药品容器和密封器的接收与储存

(a) Upon receipt and before acceptance, each container or grouping of containers of components, drug product containers, and closures shall be examined visually for appropriate labeling as to contents, container damage or broken seals, and contamination. (a)接收后入库前，对每个组份、药物成品容器和密封器的容器或是一类容器进行目检，对内容物、容器损坏或拆封和污染等情况作适当的标识。

(b) Components, drug product containers, and (b)组份、药品容器和密封器应在待验区储存，

closures shall be stored under quarantine until they have been tested or examined, whichever is appropriate, and released. Storage within the area shall conform to the requirements of 211.80.

[43 FR 45077, Sept. 29, 1978, as amended at 73 FR 51932, Sept. 8, 2008] 直至经检验完成、合格、放行。在符合211?80要求的区域中储存。

Sec. 211.84 Testing and approval or rejection of components, drug product containers, and closures. 211.84 组份、药品容器和密闭器的检测、批准或拒收。

(a) Each lot of components, drug product containers, and closures shall be withheld from use until the lot has been sampled, tested, or examined, as appropriate, and released for use by the quality control unit. (a)每批组份、药品容器和密闭器，在未经质量部门取样、检测或检查合格前，不准使用。检验合格后由质量控制部放行使用。

Sec. 211.86 Use of approved components, drug product containers, and closures. 211.86批准后的组份，药物的容器和密封器的应用

Components, drug product containers, and closures approved for use shall be rotated so that the oldest approved stock is used first. Deviation from this requirement is permitted if such deviation is temporary and appropriate. 批准使用的组份、药品容器和密封器，先入库者先用。若由此产生的偏差是暂时的和正当的，这种偏差是容许的。

Sec. 211.87 Retesting of approved components, drug product containers, and closures 211.87批准后的组分、药品容器和密封器的复检.

Components, drug product containers, and closures shall be retested or reexamined, as appropriate, for identity, strength, quality, and purity and approved or rejected by the quality control unit in accordance with 211.84 as necessary, e.g., after storage for long periods or after exposure to air, heat or other conditions that might adversely affect the component, drug product container, or closure. 药品组份、药品容器和密封器，若长期贮存或曝露在空气、热或其他可能对其产生不良影响的环境后，应由质量部门依据211?84，对均一性、规格、质量、纯度等复检，作出批准或拒收的决定。

Sec. 211.89 Rejected components, drug

product containers, and closures.

Sec. 211.89拒收的组份、药品容器和密封器

Rejected components, drug product containers, and closures shall be identified and controlled under a quarantine system designed to prevent their use in manufacturing or processing operations for which they are unsuitable. 拒收的组份、药品容器和密封器应进行标识和在隔离系统下加以控制，防止因不适当而应用在生产和加工操作中。

Sec. 211.94 Drug product containers and

closures.

Sec. 211.94药品容器和密封器

(a) Drug product containers and closures shall not be reactive, additive, or absorptive so as to (a)药品包装容器和密封器应不反应、不脱落、不吸附、不致改变药品的安全性、均一性、规

alter the safety, identity, strength, quality, or purity of the drug beyond the official or established requirements. 格、质量或纯度而超出官方的或其它的规定要求。

(b) Container closure systems shall provide adequate protection against foreseeable external factors in storage and use that can cause deterioration or contamination of the drug product. (b)容器密封系统应对储存和使用过程中可预见的能引起药品变质或污染的外部因素提供足够的防护。

(c) Drug product containers and closures shall be clean and, where indicated by the nature of the drug, sterilized and processed to remove pyrogenic properties to assure that they are suitable for their intended use. Such depyrogenation processes shall be validated. (c)药品容器和密封器应根据药品本身的性质进行清洁、灭菌和除热原，来保证其适用于预期用途。这种除热原过程要经过验证。

(d) Standards or specifications, methods of testing, and, where indicated, methods of cleaning, sterilizing, and processing to remove pyrogenic properties shall be written and followed for drug product containers and closures.

[43 FR 45077, Sept. 29, 1978, as amended at 73 FR 51932, Sept. 8, 2008] (d)药品容器和密封器的标准或规格、检测方法（指清洁和消毒方法、除热原过程）应作成文件并执行。

Subpart F--Production and Process

Controls

F--生产和加工控制Sec. 211.100 Written procedures; deviations. 211.100书面程序；偏差

(a) There shall be written procedures for production and process control designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess. Such procedures shall include all requirements in this subpart. These written procedures, including any changes, shall be drafted, reviewed, and approved by the appropriate organizational units and reviewed and approved by the quality control unit. (a)制定为保证药品的均一性、规格、质量及纯度而设计生产和加工控制程序，这些程序包括本部分内全部要求。这些书面程序（包括变更）须经有关部门起草、审核和批准，然后再经质量控制部门审核与批准。

(b) Written production and process control procedures shall be followed in the execution of the various production and process control functions and shall be documented at the time of performance. Any deviation from the written procedures shall be recorded and justified. (b)在实施各种生产和加工控制过程中，遵循已制定的书面程序，并在执行时进行记录。任何对书面程序的偏离，应作记录，并证实。

Sec. 211.101 Charge-in of components. 211.101组份的进料

Written production and control procedures shall include the following, which are designed to assure that the drug products produced 生产和控制成文程序包括下面的内容，其设计应保证所生产的药品具有它应有的或是代表的均一性、规格、质量和纯度。