1、Part 210 - CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL PART 211 - CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS210 部分人用及兽用药品的生产、加工、包装或贮存的 CGMP（概述）211 部分制剂药品的 CGMP21 Code of Federal Regulations Parts210 and 211Part 210 - C
2、URRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL210.1 Status of current good manufacturing practice regulations.210.2 Applicability of current good manufacturing practice regulations.210.3 Definitions.AUTHORITY: Secs. 201, 501, 502, 505, 506, 507
3、, 512, 701, 704 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 351, 352, 355, 356, 357, 360b, 371, 374).SOURCE: 43 FR 45076, Sept. 29, 1978, unless otherwise noted. 210.1 Status of current good manufacturing practice regulations.(a) The regulations set forth in this part and in Parts 21
4、1 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
5、the identity and strength and meets the quality and purity characteristics that it purports or is 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210.2 cGMP 法规的适用性210.3 定义210.1 cGMP 法规的地位(a) 在本部分及 21CFR 211226 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
6、量)并符合或代表其生产过程的质量及纯度等特征。represented to possess.(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
7、 and such drug, as well as the person who is responsible for the failure to comply, shall be subject to regulatory action. 210.2 Applicability of current good manufacturing practice regulations.(a) The regulations in this part and in Parts 211 through 226 of this chapter as they may pertain to a dru
8、g and in Parts 600 through 680 of this chapter as they may pertain to a biological product for human use, shall be considered to supplement, not supersede, each other, unless the regulations explicitly provide otherwise. In the event that it is impossible to comply with all applicable regulations in
9、 these parts, the regulations specifically applicable to the drug in question shall supersede the more general.(b) If a person engages in only some operations subject to the regulations in this part and in Parts 211 through 226 and Parts 600 through 680 of this chapter, and not in others, that perso
10、n need only comply with those regulations applicable to the operations in which he or she is engaged. 210.3 Definitions.(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.(b
11、) The following definitions of terms apply to this part and to Parts 211 through 226 of this chapter. (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 211226 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 211226 适用于普通药品，21CFR 600680 适用于人用生物制品，除非另有明
12、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) 如果一个人只参与本处法规和 211 至226 和 600 至 680 所要求的某些操，且不参与其它时，这个人可以只应用他参与的操作有关的法规。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 211226 部分中的术语。(b)下面定义的术语适用于本部分及 21CFR 211226。(1) Act means the Federal Food, Drug, and Cosmetic Act, as amended (2
13、1 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.(3) Component means any ingredient int
14、ended for use in the manufacture of a drug product, including those that may not appear in such drug product.(4) Drug product means a finished dosage form, for example, tablet, capsule, solution, etc., that contains an active drug ingredient generally, but not necessarily, in association with inacti
15、ve 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.(5) Fiber means any particulate contaminant with a length at least three times greater than its width.(6)Non-fiber-releasing filter means any filter, which
16、 after any appropriate pretreatment such as washing or flushing, will not release fibers into the component or drug product that is being filtered. All filters composed of asbestos are deemed to be fiber-releasing filters.(7) Active ingredient means any component that is intended to furnish pharmaco
17、logical 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 (1) 法(Act)指联邦食品、药品及化妆品法，修订版(21 U.S.C 301 et seq.)。(2) 批(Batch)指
18、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) 组分(Component)指用于药品生产的所有成份，包括那些未在药品中出现的成份。(4) 药品(Drug Product)指成品制剂(如：片剂、胶囊剂、口服液等)，通常含有一种活性成份并伴有非活性成份(但不是必需的)。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) 纤维(Fiber)指长度大于其宽度的 3 倍的任何微粒状污染物。(6) 无纤维脱落的过滤器(Non-fiber-releasing filter)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
19、滤的组分或药品中的所有过滤器。所有含石棉过滤器均被认为是有纤维脱落的过滤器。 (7) 活性成份(Active Ingredient)是指所有用于保证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分。本术语包括那些能承受药品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
20、 effect.(8) Inactive ingredient means any component other than an active ingredient.(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.(10) Lot means a batch, or a specific
21、 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
22、within specified limits.(11) Lot number, control number, or batch number means any distinctive combination of 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
23、 or other material can be determined.(12) Manufacture, processing, packing, or holding of a drug product includes packaging and labeling operations, testing, and quality control of drug products.(13) The term medicated feed means any Type B or Type C medicated feed as defined in 558.3 of this chapte
24、r. 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.(14) The term medicated premix means a Type 生产中的化学变化和为了保证其指定的活性或作用以一种经调整的形式存在于药品中的组分。(8) 非活性成份(Inactive ingredient)指不同于“活性成份”的
25、其他组分。(9) 中间产品(In-process material)是指所有经制备、复合、混合或由化学反应得到的用于药品生产或制备的物料。(10) 批（lot）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性质与质量。(11) 批号(Lot number, control number，batch number)指由字母、数字、符号或他们的组合组成，由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) 药品的生产、加工、包装
26、或贮存包括药品的包装和标签操作、检验、质量控制。(13) 药用物料(medicated feed)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 226 部分中的要求。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 manufact
27、ure of medicated premixes is subject to the requirements of Part 226 of this chapter.(15) Quality control unit means any person or organizational element designated by the firm to be responsible for the duties relating to quality control.(16) Strength means:(I) The concentration of the drug substanc
28、e (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 r
29、eference to a standard).(17) Theoretical yield means the quantity that would be produced at any appropriate phase 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(18) Actual
30、 yield means the quantity that is actually produced at any appropriate phase of manufacture, processing, or packing of a particular drug product.(19) Percentage of theoretical yield means the ratio of the actual yield (at any appropriate phase of manufacture, processing, or packing of a particular d
31、rug product) to the theoretical yield (at the same phase), stated as a percentage.(14) 药用预混合料(medicated premix)指 21CFR 558.3 中定义的 A 型药用物质。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)质量控制部门(Quality control unit)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) 含量或效价（Strength）指：()原料药的浓度(
32、如：以重量/重量、重量/体积、单位剂量/体积为基础)；和/(或)()活性(效价)也即由适当的实验室检测或由足够的临床数据得出的指定的药品治疗活性(如：可表达为对照于某标准的单位的术语)。(17) 理论产量(Theoretical yield)指在生产、加工或包装某种药品的任一适当阶段中，并且基于所使用的组分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) 实际产量(Actual yield)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) 比率(Percentage of theoretical yield)实际产量(生产、加工或包装某种药品的适当阶段
33、)与理论产量(在相同阶段)的比率，(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 c
34、onvenient subgroups of manufactured units).(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.(22) Gang-printed labeling m
35、eans labeling derived from a sheet of material on which more than one item of labeling is printed.43 FR 45076, Sept. 29, 1978, as amended at 51 FR 7389, Mar. 3, 1986; 58 FR 41353, Aug. 3, 1993EFFECTIVE DATE NOTE: At 58 FR 41353, Aug. 8, 1993, 210.3 was amended by adding paragraph (b)(22) effective A
36、ug. 3, 1994.Part 211 -CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS (21 CFR Part 211 As of April, 1996)Authority: Secs. 201, 501, 502, 505, 506, 507, 512, 701, 704 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 351, 352, 355, 356, 357, 360b, 371, 374). Source: 43 FR 4
37、5077, Sept. 29, 1978, unless otherwise noted. Subpart A-General Provisions 211.1 - Scope.211.3 - Definitions.以百分数表示。(20) 验收标准(Acceptance criteria)建立在相应的取样方法基础上的药品的质量检验标准和合格、不合格标准(如合格质量水平和不合格的质量水平)，是决定批准或拒收一批(或其他生产单元的小组)药品的必需因素。(21) 代表性样品(Representative sample)指一个样品按合理的标准抽取（如随机取样法） ，并包含若干单位（元） ，以能保证样
38、品准确描绘被取样品的物料。（22）联合印刷的贴签（Gang-printed labeling）指从一张已经印刷了至少一个项目的材料上得到的贴签。211 部分制剂药品的 CGMPA.总 则2111 范围2113 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.Subpart C-Bui
39、ldings and Facilities211.42 - 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. Subpart D-Equipment 211.63 -
40、 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. Subpart E-Control of Components and Drug Product Containers and Closures211.80 - General requirements.211.8
41、2 - Receipt and storage of untested 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 B组织与人员21122 质量控制部门的职责21125 人员资格21128 人员职责21134 顾问C厂房和设施21142 设计与建造特征21144 照
42、明21146 通风、空气过滤、空气加热与冷却21148 管件21150 污水和废料21152 洗涤和盥洗设备21156 卫生21158 保养D设备21163 设备的设计、尺寸及位置21165 设备构造21167 设备清洁与保养21168 自动化设备、机械化设备和电子设备 21172 过滤器E成分、药品容器和密封件控制21180 总要求21182 未检验的成份、药品容器和密封件的接收与贮存21184 成份、药品容器和密封件的试验、批准或拒收21186 获准的成份、药品容器和密封件的使用product containers, and closures.211.87 - Retesting of a
43、pproved components, drug product containers, and closures. 211.89 - Rejected components, drug product containers, and closures. 211.94 - Drug product containers and closures. Subpart F-Production and Process Controls 211.100 - Written procedures; deviations.211.101 - Charge-in of components. 211.103
44、 - 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.Subpart G-Packaging and Labeling Control 211.122 - M
45、aterials 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.Subpart H-Holding and Distrib
46、ution 211.142 - Warehousing procedures. 211.150 - Distribution procedures.Subpart I-Laboratory Controls 211.160 - General requirements.21187 获准的成份、药品容器和密封件的复检21189 拒收的成份、药品容器和密封件21194 药品密封容器和密封件F .生产和加工控制211100 成文的规程、偏差211101 成分的控制211103 产量计算211105 设备鉴别211110 中间体和药品的取样与检验211111 生产时间限制211113 微生物污染的控制
47、211115 返工G.包装和标签控制211122 材料的检查和使用标准211125 标签的发放211130 包装和贴签操作211132 人用非处方药（OTC）保险包装的要求211134 药品检查211137 有效期H贮存和销售211142 入库程序211150 销售程序I实验室控制 211.165 - Testing and release for distribution. 211.166 - Stability testing.211.167 - Special testing requirements. 211.170 - Reserve samples. 211.173 - Labor
48、atory animals. 211.176 - Penicillin contamination.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 produ
49、ction and control records. 211.192 - Production record review. 211.194 - Laboratory records. 211.196 - Distribution records. 211.198 - Complaint files. Subpart K-Returned and Salvaged Drug Products 211.204 - Returned drug products. 211.208 - Drug product salvaging.Subpart A-General Provisions 211.1 Scope (a) The regulations in this part contain the minimum current good manufacturing practice for preparation of drug products for administrati
