21 Code of Federal Regulations Parts

210 and 211

Part 210

- CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL PART 211

- CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS

210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CGMP Part 210 - CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL 210.1 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, 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. 210部分—人用及兽用药品的生产、加工、包装或贮存的CGMP 210.1 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 211—226部分中陈(a) The regulations set forth in this part and in 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Parts 211 through 226 of this chapter contain 设施或控制的最低标准，以保证该药品符合the minimum current good manufacturing 联邦食品、药品及化妆品法对安全性的要practice for methods to be used in, and the 求，具有均一性和效价(或含量)并符合或代facilities or controls to be used for, the manufacture, processing, packing, or holding of 表其生产过程的质量及纯度等特征。 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 regulation set (b) 凡是在药品生产、加工、包装或贮存forth in this part and in Parts 211 through 226 of 过程中存在任何不符合本部分及21CFR 211this chapter in the manufacture, processing, packing, or holding of a drug shall render such —226部分中陈述的法规的药品，依据联邦drug to be adulterated under section 食品、药品及化妆品法501 (a)(2)-(B)，501(a)(2)(B) of the act and such drug, as well 该药应被视为劣药，同时导致该事故发生的as the person who is responsible for the failure 负责人应受相应的法规的制裁。 to comply, shall be subject to regulatory action. § 210.2 Applicability of current good 210.2 cGMP法规的适用性 manufacturing practice regulations. (a) The regulations in this part and in Parts 211 through 226 of this chapter as they may pertain to a drug 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 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 person need only comply with those regulations applicable to the operations in which he or she is engaged. § 210.3 Definitions. (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) 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(a) The definitions and interpretations 分中包含的定义和解释、说明适用于21CFR contained in section 201 of the act shall be applicable to such terms when used in this part 211—226部分中的术语。 and in Parts 211 through 226 of this chapter. (b)下面定义的术语适用于本部分及21CFR 211—226。 (b) The following definitions of terms apply to this part and to Parts 211 through 226 of this chapter. (1) 法(Act) (1) Act means the Federal Food, Drug, and 指联邦食品、药品及化妆品法，修订版(21 Cosmetic Act, as amended (21 U.S.C. 301 et U.S.C 301 et seq.)。 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 intended 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 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. (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 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 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 (2) 批(Batch) 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) 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of the drug product and be present in the drug 分。 product in a modified form intended to furnish the specified activity or 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 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. (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 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 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. (8) 非活性成份(Inactive ingredient) 指不同于“活性成份”的其他组分。 (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。 (14) 药用预混合料(medicated premix) (14) The term medicated premix means a Type 558.3中定义的A型药用物质。该A medicated article as defined in 558.3 of this 指21CFR