00-cMGP中英对照版21CFR印刷版-2

1、21 Code of Federal Regulatio ns Parts210 and 211Part 210-CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERALPART 211-CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS210部分一人用及兽用药品的生产、加工、包装或贮存的CGMR概述）211部分一制剂药品的 CGMPPart 210 - CURRENT

2、 GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL210.1 Status of curre nt good manu facturi ng practice regulati ons.210.2 Applicability of current good manu facturi ng practice regulati ons.210.3 Defi nitio ns.AUTHORITY: Secs. 201, 501, 502, 505, 506,

3、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, uni ess otherwise no ted.§210.1 Status of curren t good manu facturi ng practice regulati ons.(a) The regulatio ns set forth in this part an

4、d in Parts 211 through 226 of this chapter contain the minimum curre nt good manu facturi ng practice for methods to be used in, and the facilities or con trols to be used for, the manu facture, process ing, pack ing, or holdi ng of a drug to assure that such drug meets the requireme nts of the act

5、as to safety, and has the ide ntity and stre ngth and meets the quality and purity characteristics that it purports or is210部分一人用及兽用药品的生产、力口 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21CFR211 226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

6、及化妆品法对安全性的要 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。represe nted 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,pack ing, or holdi ng of a drug shall ren der such drug to be adulteratedun dersect

7、 ion501(a)(2)(B) of the act and such drug, as well as the pers on who is resp on sible for the failure to comply, shall be subject to regulatory action.§210.2 Applicability of curre nt good manu facturi ng practice regulati ons.(a) The regulati ons in this part and in Parts 211 through 226 of t

8、his chapter as they may perta in to a drug and in Parts 600 through 680 of this chapter as they may pertain to a biological product for huma n use, shall be con sidered to suppleme nt, not supersede, each other, uni ess the regulations explicitly provide otherwise. In the event that it is impossible

9、 to comply with all applicable regulati ons in these parts, the regulations specifically applicable to the drug in questio n shall supersede the more gen eral.(b) If a pers on en gages in only some operati ons subject to the regulati ons in this part and in Parts 211 through 226 and Parts 600 throug

10、h 680 of this chapter, and not in others, that pers onn eed only comply with thoseregulations applicable to the operationsinwhich he or she is en gaged.§210.3 Defi nitio ns.(a) The definitions and interpretations contained in secti on 201 of the act shall be applicable to such terms whe n used

11、in this part and in Parts 211 through 226 of this chap ter.(b) 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(

12、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部分中包含的定义和解释、说明适用于21CFR211 226部分中的术语。(b) 下面定义的术语适用于本部分及21CFR211 226。(1)法(Act)(1) Act

13、 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 inten ded to have un iform character and quality, with in specified limits, and is produced accord ing to a sin glemanu facturi ng order duri ng

14、 the same cycle of manu facture.(3) Component means any ingredient intended for use in the manufacture of a drug product,in cludi ng those that may not appear in such drug product.(4) Drug product means a fini shed dosage form, for example, tablet, capsule, solutio n, etc., that contains an active d

15、rug in gredie nt gen erally, but not n ecessarily, in associati on with in active in gredie nts. The term alsoin cludes a fini shed dosage form that does not contain an active in gredie nt but is inten ded to be used as a placebo.(5) Fiber means any particulate con tam inant with a len gth at least

16、three times greater tha n its width.(6) Non-fiber-releasingfilter means any filter,which after any appropriate pretreatme nt suchas 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-releas i

17、ng filters.(7) Active ingredient means any component that is intended to furnish pharmacological activity or other direct effect in the diag no sis, 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 in clud

18、es those comp onents that mayundergo chemical change in the manufacture 指联邦食品、药品及化妆品法，修订版 (21U.S.C 301 et 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。(3)组分(Compo nent)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。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

19、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-releasi ng 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

20、的形式存在于药品中的组of the drug product and be prese nt in the drug product in a modified form inten ded tofurnishthe specified activity or effect.(8) In active in gredie nt means any comp onent other tha n an ''active in gredie nt."(9) In-process material means any material fabricated, compo un

21、 ded, ble nded, or derived by chemical react ion that is produced for, and used in, the preparati on of the drug product.(10) Lot means a batch, or a specific identified portion of a batch, havi ng un iform character and quality with in specified limits; or, i n the case of a drug product produced b

22、y con ti nu ous process, it is a specific identified amount produced in a unit of time or quantity in a manner that assures its hav ing uniform character and quality within specified limits.(11) Lot number, control number, or batchnu mber means any disti nctive comb in ati on of letters, nu mbers, o

23、r symbols, or any comb in ati on of them, from which the complete history of the manufacture, process ing, packing, holding, and distribution of a batch or lot of drug product or other material can be determ in ed.(12) Manufacture, processing, packing, orholdi ng of a drug productin cludes packagi n

24、gand labeli ng operati ons, test ing, and quality con trol of drug products.(13) The term medicated feed means any Type B or Type C medicated feed as defi ned in558.3 of this chapter. The feed contains one or more drugs as defi ned in sect ion 201(g) of the act. The manu facture of medicated feeds i

25、s subject to the requireme nts of Part 225 of this chapter.(14) The term medicated premix means a Type A medicated article as defi ned in 558.3 of this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

26、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 nu mber)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

27、(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)指21CFR558.3中定义的A型药用物质。该 chapter. The article contains one or more drugs as defi ned in sect ion 201(g) of the act. The manu facture of medicated premixes is subject to the requireme nts of Part 226 of this chapter.(15) Quali

28、ty con trol un itmeans any pers on ororga ni zati onal eleme nt desig nated by the firmto be resp on sible for the duties relat ing to quality con trol.(16) Strength means:(I) The concen trati on of the drug substa nee (for example, weight/weight, weight/volume, or unit dose/volume basis), an d/or (

29、ii) The pote ncy, that is, the therapeutic activity of the drug product as in dicated by appropriate laboratory tests or by adequately developed and con trolled cli ni cal data (expressed, for example, in terms of un its by reference to a sta ndard).(17) Theoretical yield means the quantity that wou

30、ld be produced at any appropriate phase of manufacture, processing,or packingof aparticular drug product,based upon thequantity of componentsto be used, in theabse neeof any lossor error in actualproduct ion(18) Actual yield means the qua ntity that is actually produced at any appropriate phase of m

31、anu facture, process ing, or pack ing of a particular drug product.(19) Percentage of theoretical yield means the ratio of the actual yield (at any appropriate phase of manufacture, process ing, or pack ingof a particular drug product) to the theoretical yield (at the same phase), stated as a perce

32、ntage.(20) Accepta nee criteria means the product specifications and acceptance/rejection criteria,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21CFR226部分中的要求。(15) 质量控制部门(Qualitycontrol 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：(I )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)(n)活性

33、(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(Percentageof theoreticalyield)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) 验收

34、标准(Acceptanee criteria)建立在相应的取样方法基础上的药品的质such as acceptable quality level and un acceptable quality level, with an associated sampli ng pla n, that are n ecessary for making a decisi on to accept or reject a lot or batch (or any other convenient subgroups of manu factured un its).(21) Representative

35、 sample means a sample that con sists of a nu mber of un its that are drawn based on rational criteria such asran dom sampli ng and inten ded to assure that the sample accurately portrays the material being sampled.(22) Gan g-pri nted labeli ng means labeli ng derived from a sheet of material on whi

36、ch 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 Aug. 3, 1994.Part 211 -CURRENT GOODMANUFACTURING PRACT

37、ICE 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 45077, Sept. 29, 1978, unless otherwise noted.Subpart A-Ge

38、 neral Provisi ons$11.1 - Scope.§?11.3 - Definitions.Subpart B-Organization and Personnel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(或其他生产单兀的小组 )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)，并包含右干单位(兀)，以能保证样品 准确描绘被取样品的物料。(22)联合印刷的贴签(Gang-printedlabeli ng )指从一张已经印刷了至少一个项目的材

39、料上得到的贴签。211部分一制剂药品的 CGMPA. 总贝U211?1范围211?定义B. 组织与人员211辺2质量控制部门的职责211辺5人员资格§211 22 - Responsibilitiesof quality controlun it.§211.25 - Perso nnel qualificatio ns.§211.28 - Perso nnel respo nsibilities.§211.34 - Co nsulta nts.Subpart C-Buildings and Facilities§211.42 - Desig n

40、 and con struct ion features.§211.44 - Lighti ng.§211.46 - Ventilation, air filtration, air heating and cooli ng.§211.48 - Plumbi ng.§211.50 - Sewage and refuse.§211.52 - Washi ng and toilet facilities.§211.56 - San itatio n.§211.58 - Maintenance.Subpart D-Equipme

41、nt§211.63 - Equipme nt desi gn, size, and locatio n.§211.65 - Equipme nt con struct ion.§211.67-Equipme ntclea ningandmaintenance.§211.68- Automatic,mecha ni cal,andelectr onic equipme nt.§211.72 - Filters.SubpartE-C on trolof Comp onentsand211辺8人员职责211?34顾问C. 厂房和设施211?42设计与

42、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洗涤和盥洗设备211?56卫生211?58保养D. 设备211?53设备的设计、尺寸及位置211?55设备构造211?57设备清洁与保养211?58自动化设备、机械化设备和电子设备211712过滤器E. 成分、药品容器和密封件控制211730总要求211752未检验的成份、药品容器和密封件的 接收与贮存2117S4成份、药品容器和密封件的试验、批准或拒收2117S6获准的成份、药品容器和密封件的使 用211 7S7获准的成份、药品容器和密封件的复 检2117S9拒收的成份、药品

43、容器和密封件211 794药品密封容器和密封件Drug Product Containers and Closures§211.80 - Ge neral requireme nts.§211.82- Receipt and storage of untestedcomp onen ts, drug product contain ers, and closures.§211.84 - Test ing and approval or rejecti on of comp onen ts, drug productcontain ers,andclosures.$

44、11.86 - Use of approved components, drug product contain ers, and closures.$11.87 - Retesti ng of approvedcomponents,drug product contain ers, and closures.§211 89 - Rejected comp onen ts, drug productcontain ers, and closures.§ 211.94- Drug product containers andclosures.SubpartF-Product

45、ionandProcessF .生产和加工控制211?I00成文的规程、偏差211?101成分的控制211?103产量计算211?105设备鉴别211?110中间体和药品的取样与检验211?111生产时间限制211?113微生物污染的控制211?115 返工G. 包装和标签控制211?122材料的检查和使用标准211?125标签的发放211?130包装和贴签操作211?132人用非处方药（OTC保险包装的要 求211?134药品检查211?137有效期H. 贮存和销售211?142入库程序211?150销售程序I ?实验室控制211?160总要求211?165销售前的检验与发放211?166稳

46、定性试验211?167特别检验要求211?170 留样Con trols§211.100 - Writte n procedures; deviatio ns.§211.101 - Charge-in of compo nents.§211.103 - Calculatio n of yield.§211.105 - Equipment identification.§211.110 - Sampli ng and testi ng of in-process materials and drug products.§211.111

47、- Time limitati ons on product ion.§211.113-Con trolof microbiologicalcon tam in atio n.§211.115 - Reprocessi ng.Subpart G-Packagi ng and Labeli ng Con trol§211.122 - Materials exam in ati on and usage criteria.§211.125 - Label ing issua nee.§211.130 - Packag ing and labeli

48、ng operati ons.§211.132- Tamper-evide ntpackag ingrequireme ntsfor over-the-co un ter(OTC)huma n drug products.§211.134 - Drug product in spectio n.§211.137 - Expiration dat ing.Subpart H-Holding and Distribution§211.142 - Warehous ing procedures.§211.150 - Distribution proc

49、edures.Subpart I-I aboratory Controls§211.160 - General requireme nts.§211.165 - Testi ng and release for distributio n.§211.166 - Stability test in g.§211.167 - Special test ing requireme nts.§211.170 - Reserve samples.§211.173 - Laboratory animals.§211.176 - Peni

50、cillin contamination.Subpart J-Records and Reports§211.180 - General requireme nts.§211.182 - Equipme nt clea ning and use log.§ 211.184- Compo nent,drug productcontainer, closure, and labeli ng records.§ 211.186 - Master production and control records.§ 211.188 - Batch prod

51、uctionand controlrecords.§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 salvagi ng.Subpar

52、t A-Ge neral Provisi ons§211.1 Scope(a) The regulati ons in this part contain the minimum curre nt good manu facturi ng practice for preparati on of drug products foradm ini strati on to huma ns or ani mals.(b) The curre nt good manu facturi ng practice regulations in this chapter, as they pert

53、ain to drug products, and in parts 600 through 680 of this chapter, as they perta in to biological products for huma n use, shall be con sidered to suppleme nt, not supersede, the regulati ons in this part uni ess the regulati ons explicitly provide otherwise. In the even t it is impossible to compl

54、y with applicable regulati ons both in211?I73实验动物211?I76青霉素污染J .记录和报告211?180总要求211?182设备清洁和使用记录211?184成份、药品容器、密封件及标签记 录211?186主要生产和控制的记录211?188批生产和控制记录211?192产品记录复查211?194实验室记录211?196销售记录211?198客户投诉档案K.退货的药品和回收处理211辺04退货的药品211辺08药品的回收利用A.总 贝U211?1范围(a) 本部分的条例包含人用或兽用药品制 备的现行最低限度的药品生产质量管理规范(GMP(b) 在本章

55、里的这些针对药品的现行GMP条例和本章600至800的所有部分针对人 用生物制品的现行 GMP条例，除非明确另 有说明者外，应认为是对本部分条例的补 充，而是不代替。本章其他部分或本章 600 至680各部分和本部分均可适用的条例，this part and in other parts of this chapter or in parts 600 through 680 of this chapter, the regulation specifically applicable to the drug product in questio n shall supersede the re

56、gulati on in this part.(c) Pending con siderati on of a proposed exempti on, published in the Federal Register of September 29, 1978, the requireme nts in this part shall not be en forced for OTC drug products if the products and all their in gredie nts are ordin arily marketed and con sumed as huma

57、 n foods, and which products may also fall with in the legal defi niti on of drugs by virtue of their inten ded use. Therefore, un til further notice, regulations under part 110 of this chapter, and where applicable, parts 113 to 129 of this chapter, shall be applied in determ ining whether these OT

58、C drug products that are also foods are manu factured, processed, packed, or held un der curre nt good manu facturi ng practice.§211.3 Definitions.The definitions set forth in210.3 of thischapter apply in this part.Subpart B-Orga ni zatio n and Pers onnel§ 211.22 Responsibilities of quality control un it.(a) There shall be a quality con trol un it that shall have the resp on sibility and authority to approve or reject all comp onen ts, drug product conta