21-CFR-210&211-cGMP中英对照版

Part210-CURRENTGOODMANUFACTURINGPRACTICEINMANUFACTURING,PROCESSING,PACKING,ORHOLDINGOFDRUGS;GENERALPART211-CURRENTGOODMANUFACTURINGPRACTICEFORFINISHEDPHARMACEUTICALS210部分—人用及兽用药品的生产、加工、包装或贮存的CGMP（概述）211部分—制剂药品的CGMP21CodeofFederalRegulationsParts210and211Part210-CURRENTGOODMANUFACTURINGPRACTICEINMANUFACTURING,PROCESSING,PACKING,ORHOLDINGOFDRUGS;GENERAL210.1Statusofcurrentgoodmanufacturingpracticeregulations.210.2Applicabilityofcurrentgoodmanufacturingpracticeregulations.210.3Definitions.AUTHORITY:Secs.201,501,502,505,506,507,512,701,704oftheFederalFood,Drug,andCosmeticAct(21U.S.C.321,351,352,355,356,357,360b,371,374).SOURCE:43FR45076,Sept.29,1978,unlessotherwisenoted.§210.1Statusofcurrentgoodmanufacturingpracticeregulations.(a)TheregulationssetforthinthispartandinParts211through226ofthischaptercontaintheminimumcurrentgoodmanufacturingpracticeformethodstobeusedin,andthefacilitiesorcontrolstobeusedfor,themanufacture,processing,packing,orholdingofadrugtoassurethatsuchdrugmeetstherequirementsoftheactastosafety,andhastheidentityandstrengthandmeetsthequalityandpuritycharacteristicsthatitpurportsoris210部分—人用及兽用药品的生产、加工、包装或贮存的CGMP210.1cGMP法规的地位210.2cGMP法规的适用性210.3定义210.1cGMP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。representedtopossess.(b)ThefailuretocomplywithanyregulationsetforthinthispartandinParts211through226ofthischapterinthemanufacture,processing,packing,orholdingofadrugshallrendersuchdrugtobeadulteratedundersection501(a)(2)(B)oftheactandsuchdrug,aswellasthepersonwhoisresponsibleforthefailuretocomply,shallbesubjecttoregulatoryaction.§210.2Applicabilityofcurrentgoodmanufacturingpracticeregulations.(a)TheregulationsinthispartandinParts211through226ofthischapterastheymaypertaintoadrugandinParts600through680ofthischapterastheymaypertaintoabiologicalproductforhumanuse,shallbeconsideredtosupplement,notsupersede,eachother,unlesstheregulationsexplicitlyprovideotherwise.Intheeventthatitisimpossibletocomplywithallapplicableregulationsintheseparts,theregulationsspecificallyapplicabletothedruginquestionshallsupersedethemoregeneral.(b)IfapersonengagesinonlysomeoperationssubjecttotheregulationsinthispartandinParts211through226andParts600through680ofthischapter,andnotinothers,thatpersonneedonlycomplywiththoseregulationsapplicabletotheoperationsinwhichheorsheisengaged.§210.3Definitions.(a)Thedefinitionsandinterpretationscontainedinsection201oftheactshallbeapplicabletosuchtermswhenusedinthispartandinParts211through226ofthischapter.(b)ThefollowingdefinitionsoftermsapplytothispartandtoParts211through226ofthischapter.(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。210.2cGMP法规的适用性(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，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)ActmeanstheFederalFood,Drug,andCosmeticAct,asamended(21U.S.C.301etseq.).(2)Batchmeansaspecificquantityofadrugorothermaterialthatisintendedtohaveuniformcharacterandquality,withinspecifiedlimits,andisproducedaccordingtoasinglemanufacturingorderduringthesamecycleofmanufacture.(3)Componentmeansanyingredientintendedforuseinthemanufactureofadrugproduct,includingthosethatmaynotappearinsuchdrugproduct.(4)Drugproductmeansafinisheddosageform,forexample,tablet,capsule,solution,etc.,thatcontainsanactivedrugingredientgenerally,butnotnecessarily,inassociationwithinactiveingredients.Thetermalsoincludesafinisheddosageformthatdoesnotcontainanactiveingredientbutisintendedtobeusedasaplacebo.(5)Fibermeansanyparticulatecontaminantwithalengthatleastthreetimesgreaterthanitswidth.(6)Non-fiber-releasingfiltermeansanyfilter,whichafteranyappropriatepretreatmentsuchaswashingorflushing,willnotreleasefibersintothecomponentordrugproductthatisbeingfiltered.Allfilterscomposedofasbestosaredeemedtobefiber-releasingfilters.(7)Activeingredientmeansanycomponentthatisintendedtofurnishpharmacologicalactivityorotherdirecteffectinthediagnosis,cure,mitigation,treatment,orpreventionofdisease,ortoaffectthestructureoranyfunctionofthebodyofmanorotheranimals.Thetermincludesthosecomponentsthatmayundergochemicalchangeinthemanufacture指联邦食品、药品及化妆品法，修订版(21U.S.C301etseq.)。(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(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(DrugProduct)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。(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-releasingfilter)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(ActiveIngredient)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的形式存在于药品中的组ofthedrugproductandbepresentinthedrugproductinamodifiedformintendedtofurnishthespecifiedactivityoreffect.(8)Inactiveingredientm