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1、21CodeofFederalRegulationsParts210and211Part210-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CGMPPart210-CURRENTGOODMANUFACTURINGPRACTICEINMA
2、NUFACTURING,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
3、,355,356,357,360b,371,374).SOURCE:43FR45076,Sept.29,1978,unlessotherwisenoted.§210.1Statusofcurrentgoodmanufacturingpracticeregulations.(a)TheregulationssetforthinthispartandinParts211through226ofthischaptercontaintheminimumcurrentgoodmanufacturingpracticeformethodstobeusedin,andthefacilitiesorcont
4、rolstobeusedfor,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
5、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,orholdingofadrugshallr
6、endersuchdrugtobeadulteratedundersection501(a)(2)(B)oftheactandsuchdrug,aswellasthepersonwhoisresponsibleforthefailuretocomply,shallbesubjecttoregulatoryaction.§210.2Applicabilityofcurrentgoodmanufacturingpracticeregulations.(a)TheregulationsinthispartandinParts211through226ofthischapterastheymaype
7、rtaintoadrugandinParts600through680ofthischapterastheymaypertaintoabiologicalproductforhumanuse,shallbeconsideredtosupplement,notsupersede,eachother,unlesstheregulationsexplicitlyprovideotherwise.Intheevent
