美国cGMP-中英文对照

21CFRPart210&211Page1of48PART210CURRENTGOODMANUFACTURINGPRACTICEINMANUFACTURING,PROCESSING,PACKING,ORHOLDINGOFDRUGS;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.210.1Statusofcurrentgoodmanufacturingpracticeregulations.210.1cGMP的法规地位。(a)Theregulationssetforthinthispartandinparts211through226ofthischaptercontaintheminimumcurrentgoodmanufacturingpracticeformethodstobeusedin,andthefacilitiesorcontrolstobeusedfor,themanufacture,processing,packing,orholdingofadrugtoassurethatsuchdrugmeetstherequirementsoftheactastosafety,andhastheidentityandstrengthandmeetsthequalityandpuritycharacteristicsthatitpurportsorisrepresentedtopossess.(a)在本部分及本章第211－226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)Thefailuretocomplywithanyregulationsetforthinthispartandinparts211through226ofthischapterinthemanufacture,processing,packing,orholdingofadrugshallrendersuchdrugtobeadulteratedundersection501(a)(2)(B)oftheactandsuchdrug,aswellasthepersonwhoisresponsibleforthefailuretocomply,shallbesubjecttoregulatoryaction.(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21CFR211—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)Ownersandoperatorsofestablishmentsengagedintherecovery,donorscreening,testing(includingdonortesting),processing,storage,labeling,packaging,ordistributionofhumancells,tissues,andcellularandtissue-basedproducts(HCT/Ps),asdefinedin1271.3(d)ofthischapter,thataredrugs(subjecttoreviewunderanapplicationsubmittedundersection505oftheactorunderabiologicalproductlicenseapplicationundersection351ofthePublicHealthServiceAct),aresubjecttothedonor-eligibilityandapplicablecurrentgoodtissuepracticeproceduressetforthinpart1271subpartsCandDofthischapter,inadditiontotheregulationsinthispartandinparts211through226ofthischapter.Failuretocomplywithanyapplicableregulationsetforthinthis(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211－226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211—226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。21CFRPart210&211Page2of48part,inparts211through226ofthischapter,inpart1271subpartCofthischapter,orinpart1271subpartDofthischapterwithrespecttothemanufacture,processing,packingorholdingofadrug,rendersanHCT/Padulteratedundersection501(a)(2)(B)oftheact.SuchHCT/P,aswellasthepersonwhoisresponsibleforthefailuretocomply,issubjecttoregulatoryaction.Sec.210.2Applicabilityofcurrentgoodmanufacturingpracticeregulations.210.2cGMP法规的适用性(a)Theregulationsinthispartandinparts211through226ofthischapterastheymaypertaintoadrug;inparts600through680ofthischapterastheymaypertaintoabiologicalproductforhumanuse;andinpart1271ofthischapterastheyareapplicabletoahumancell,tissue,orcellularortissue-basedproduct(HCT/P)thatisadrug(subjecttoreviewunderanapplicationsubmittedundersection505oftheactorunderabiologicalproductlicenseapplicationundersection351ofthePublicHealthServiceAct);shallbeconsideredtosupplement,notsupersede,eachother,unlesstheregulationsexplicitlyprovideotherwise.Intheeventofaconflictbetweenapplicableregulationsinthispartandinotherpartsofthischapter,theregulationspecificallyapplicabletothedrugproductinquestionshallsupersedethemoregeneral.(a)本部分及21CFR211-226适用于普通药品，21CFR600-680适用于人用生物制品，21CFR1271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)Ifapersonengagesinonlysomeoperationssubjecttotheregulationsinthispart,inparts211through226ofthischapter,inparts600through680ofthischapter,andinpart1271ofthischapter,andnotinothers,thatpersonneedonlycomplywiththoseregulationsapplicabletotheoperationsinwhichheorsheisengaged.(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)Aninvestigationaldrugforuseinaphase1study,asdescribedin312.21(a)ofthischapter,issubjecttothestatutoryrequirementssetforthin21U.S.C.351(a)(2)(B).Theproductionofsuchdrugis(c)在21CFR312.21(a)部分描述的要调查的第一阶段研究的药品要服从在21U.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21CFRPart210&211Page3of48exemptfromcompliancewiththeregulationsinpart211ofthischapter.However,thisexemptiondoesnotapplytoaninvestigationaldrugforuseinaphase1studyoncetheinvestigationaldrughasbeenmadeavailableforusebyorforthesponsorinaphase2orphase3study,asdescribedin312.21(b)and(c)ofthischapter,orthedrughasbeenlawfullymarketed.Iftheinvestigationaldrughasbeenmadeavailableinaphase2orphase3studyorthedrughasbeenlawfullymarketed,thedrugforuseinthephase1studymustcomplywithpart211.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。[69FR29828,May25,2004,asamendedat73FR40462,July15,2008]Sec.210.3Definitions.210.3定义(a)Thedefinitionsandinterpretationscon