美国cGMP-中英文对照.doc

21CFR Part 210&211PART 210 CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL210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211226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 donoreligibility 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 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.(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211226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211226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。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 tissuebased 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 600680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 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。 （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, 2008Sec。 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 211226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 211226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 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.(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 anactive ingredient。（8）非活性成份指不同于“活性成份”的其他任何组份。(9) Inprocess 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 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.（11）批号指由字母、数字、符号或他们的组合构成,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 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(） 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)(） 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 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。(17）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) Gangprinted 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， 2008Code of Federal RegulationsTitle 21， Volume 4Revised as of April 1, 2009CITE： 21CFR211TITLE 21-FOOD AND DRUGSCHAPTER I-FOOD AND DRUG ADMINISTRATIONDEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER C-DRUGS： GENERAL PART 211 CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS211部分 对于成品制剂的现行GMPSubpart AGeneral 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 EControl of Components and Drug Product Containers and Closures 211。80 General requirements。 211。82 - 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 product containers， and closures。 211。87 - Retesting of approved components， dr