Part 210 - Current Good Manufacturing Practice In Manufacturing, Processing, Packing, Or Holding Of Drugs; General
药品制造、加工、包装或贮存cGMP总则
210.1 Status of current good manufacturing practice regulations
cGMP法规的地位（2009年12月10日）
(a) The regulations set forth in this Part and in Parts 211, 225, and 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.
本部分和本卷第211、225和226部分所列条例载有目前用于制造、加工、包装或贮存药物的设施或控制的最低良好制造做法，以确保此类药物符合该法对安全性的要求，具有其特性和优势，符合其规定或所代表的质量和纯度特征。
(b) The failure to comply with any regulation set forth in this Part and in Parts 211, 225, and 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.
在药品的制造、加工、包装或贮存过程中，如果不遵守本部分和本卷第211、225和226部分中规定的任何规定，将导致该药品依据《美国法典》第501(a)(2)(B)（目前为21 U.S.C.351）条被认定为掺假，该药品以及未能遵守该规定的责任人应受到监管行动的约束。
(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, 225, and 226 of this Chapter. Failure to comply with any applicable regulation set forth in this Part, in Parts 211, 225, and 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.
根据本卷第1271.3(D)节的定义，从事人体细胞、组织以及细胞和组织产品(HCT/Ps)的回收、捐赠者筛选、测试(包括捐赠者测试)、加工、贮存、标签、包装或分销的机构的所有者和经营者，是药物(根据该法第505条提交的申请或根据公共卫生服务法第351条提交的生物制品许可证申请)的所有者和经营者，必须遵守第122部分规定的捐赠者资格和适用的现行良好组织实践程序。除本部以及本章第211、225和226部分中的规定外。未能遵守本章第211、225和226部分、本章第1271节C子节或本章第1271节D节关于药品的制造、加工、包装或贮存的任何适用规定，将构成根据该法第501(A)(2)(B)节掺假的HCT/P。这些HCT/P以及未能遵守的责任人将受到监管行动的影响。
210.2 Applicability of current good manufacturing practice regulations
cGMP法规适用范围（2009年12月10日）
(a) The regulations in this Part and in Parts 211, 225, and 226 of this Chapter as they may pertain to a drug; in Parts 600 through 680 of this Chapteras 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.
本部分以及本章的211、225和226节中的法规适用，药物生产有关；在本章的第600至680部分中使用，因为它们可能与人类使用的生物产品有关；在本章的第1271章节中适用，因为它们适用于作为药物的人体细胞，组织或基于细胞或组织的产品（HCT / P）（根据该法案第505条提交的申请或根据 根据《公共卫生服务法》第351条获得的生物产品许可申请）； 除非法规另有明确规定，否则应视为相互补充，而不是相互取代。 如果本部分与本章其他部分中适用的法规发生冲突，则专门适用于所涉药品的法规为准。
(b) If a person engages in only some operations subject to the regulations in this Part, in Parts 211, 225, and 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.
如果一个人只从事本部分、本章第211、225和226部分、本章第600至680章节以及本章第1271部分，而不是其他部分的某些业务，则此人只需遵守适用于其所从事业务的规定。
(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 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 escribed 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.
用于第1阶段临床研究的药物，如本章312.21(A)所述，受“美国法典”第21篇第351(A)(2)(B)节规定的法规约束。 该药品的生产不受本章第211条规定限制。但是，如本章312.21(B)和(C)所述，一旦研究药物在第二阶段或第三阶段研究中提供给患者或普通志愿者受试者使用，或者药物已经合法上市，则这一豁免不适用于在第一阶段研究中使用的研究药物。如果研究药物已在第2阶段或第3阶段研究中获得，或该药物已合法上市，则在第1阶段研究中使用的药物必须符合第211部分的规定。
[69 FR 29828, May 25, 2004, as amended at 73 FR 40462, July 15, 2008; 74 FR 65431, Dec. 10, 2009]
修订历史：
2004年5月25日第69卷《美国联邦公报》29828页，
2008年7月15日第73卷《美国联邦公报》40462页，
2009年12月10日第74卷《美国联邦公报》65431页
210.3 Definitions
定义（2009年12月10日）
(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, 225, and 226 of this Chapter.
该法第201条所载的定义和解释适用于本部分和本章第211、225和226部分使用的此类术语。
(b) The following definitions of terms apply to this Part and to Parts 211, 225, and 226 of this Chapter.
以下术语定义适用于本部分和本章第 211、225 和 226 部分。
✱(1) Act--means the Federal Food, Drug, and Cosmetic Act, as amended (21 U.S.C. 301 et seq.).
法--是指经修订的《联邦食品、药物和化妆品法》（美国法典第21卷第301条及其后各条）。
✱(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.
（整）批--是指在规定限度内，按照同一生产周期内单一制造顺序生产的具有统一性质和质量的药物或其他材料的特定数量。
✱(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.
成分--是指用于制造药物产品的任何成分，包括可能未出现在此类药物产品中的成分。
✱(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.
药品--指成品剂型，例如片剂、胶囊、溶液等，其通常（但不一定）含有与非活性成分相关的活性药物成分，该术语还包括不含活性成分但打算用作安慰剂的成品剂型。
✱(5) Fiber--means any Particulate contaminant with a length at least three times greater than its width.
纤维--是指长度至少大于其宽度的三倍的任何颗粒污染物。
✱(6) Nonfiber 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.
无纤维释析出过滤器--是指任何过滤器，在适当的预处理（如洗涤或冲洗）后，不会将纤维释放到正在过滤的组件或药物产品中。
✱(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.
活性成分--指在疾病的诊断、治愈、缓解、治疗或预防中提供药理活性或其他直接作用，或影响人或其他动物身体结构或任何功能的任何成分。该术语包括那些在药品生产过程中可能发生化学变化的成分，这些成分以改性形式存在于药品中，以提供规定的活性或效果。
✱(8) Inactive ingredient--means any component other than an active ingredient.
非活性成分--是指活性成分以外的任何成分。
✱(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.
加工材料--是指为制备药品而制造、复合、混合或通过化学反应衍生的任何材料。
✱(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.
批--是指一批或一批特定确定部分，在规定范围内具有统一的性质和质量：或者，对于连续加工生产的药品，则以时间或数量部门生产的特定标识量，以确保其在规定限度内具有统一的性质和质量。
✱(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 istribution of a batch or lot of drug product or other material can be determined.
批号、控制号或批号--是指任何字母、数字或符号的任意组合，或它们的任何组合，可以确定一批或大量药品或其他材料的制造、加工、包装、贮存和分销的完整历史。
✱(12) Manufacture, processing, packing, or holding of a drug product--includes packaging and labeling operations, testing, and quality control of drug products.
药品的制造、加工、包装、贮存--包括药品的包装、贴签操作、检测、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.
药用物料--指本章第558.3条所定义的任何B型或C型药用物料。药用物料包含该行为第201(g)节中定义的一种或多个药物。药用物料的制造须符合本章第225部分的要求。
✱(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.
药物预混合物--是指本章第 558.3 条中定义的 A 类药物。该条包含该行为第 201(g)节中定义的一种或多个药物。药物预混合物的制造应符合本章第226部分的要求。
✱(15) Quality control unit--means any person or organizational element designated by the firm to be responsible for the duties relating to quality control.
质量控制部门--是指公司指定负责质量控制职责的人员或者组织机构。
✱(16) Strength means:
规格：
(i) The concentration of the drug substance (for example, weight/weight, weight/volume, or unit dose/volume basis), and/or
药物物质的浓度（例如，重量/重量、重量/体积或单位剂量/体积基础）和/或
(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).
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(例如可表达为相对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 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.
理论产量--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) Actual yield--means the quantity that is actually produced at any appropriate phase of manufacture, processing, or packing of a Particular drug product.
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.
理论收率的百分比--实际产量(生产、加工或包装某种药品的适当阶段)与理论产量(在相同阶段)的比率，以百分数表示。
✱(20) Acceptance criteria--means the product specifications and cceptance/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).
验收标准--是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) 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.
代表性样本--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），以能保证样品准确描绘被取样品的物料。
(22) Gang-printed labeling-- means labeling derived from a sheet of material on which more than one item of labeling is printed.
联合印刷标签-是指从打印多个标签的材料表中提取的标签。指一张材料上打印了一项以上内容的标签。
