cGMP中英对照版 (CFR210-211)

21 Code of Federal Regulations Parts 210 and 211

Part 210 - Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General

210部分—人用及兽用药品的生产、加工、包装或贮存的cGMP（概述）

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) 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) The following definitions of terms apply to this part and to Parts 211 through 226 of this chapter. (1) Act means the Federal Food, Drug, and Cosmetic Act, as amended (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. (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 (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 Ingred

ient) 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 (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。 (1) 法(Act) 指联邦食品、 药品及化妆品法， 修订版(21 U.S.C seq.)。 (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。 301 et (b)下面定义的术语适用于本部分及 21CFR 211—226。 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) 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。

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. (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.

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分。

(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) Manufacture, processing, packing, or holding of a drug (12) 药品的生产、加工、包装或贮存 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 cha …… 此处隐藏：39875字，全部文档内容请下载后查看。喜欢就下载吧 ……