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1、实用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CG
2、MPPart210-CURRENTGOODMANUFACTURINGPRACTICEINMANUFACTURING,PROCESSING,PACKING,ORHOLDINGOFDRUGS;GENERAL210.1Statusofcurrentgoodmanufacturingpracticeregulations.210.2Applicabilityofcurrentgoodmanufacturingpracticeregulations.210.3Definitions.AUTHORITY:Secs.2
3、01,501,502,505,506,507,512,701,704oftheFederalFood,Drug,andCosmeticAct(21U.S.C.321,351,352,355,356,357,360b,371,374).SOURCE:43FR45076,Sept.29,1978,unlessotherwisenoted.§210.1Statusofcurrentgood210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
4、.3定义文档实用manufacturingpracticeregulations.(a)TheregulationssetforthinthispartandinParts211through226ofthischaptercontaintheminimumcurrentgoodmanufacturingpracticeformethodstobeusedin,andthefacilitiesorcontrolstobeusedfor,themanufacture,processing,packing,o
5、rholdingofadrugtoassurethatsuchdrugmeetstherequirementsoftheactastosafety,andhastheidentityandstrengthandmeetsthequalityandpuritycharacteristicsthatitpurportsorisrepresentedtopossess.(b)ThefailuretocomplywithanyregulationsetforthinthispartandinParts211thr
6、ough226ofthischapterinthemanufacture,processing,packing,orholdingofadrugshallrendersuchdrugtobeadulteratedundersection501(a)(2)(B)oftheactandsuchdrug,aswellasthepersonwhoisresponsibleforthefailureto210.1cGMP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
7、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。(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。文档实用comply,shallbesubjecttoregulatoryaction.§2
8、10.2Applicabilityofcurrentgoodmanufacturingpracticeregulations.(a)TheregulationsinthispartandinParts211through226ofthischapterastheymaypertaintoadrugandinParts600through680ofthischapterastheymaypertaintoabiologicalp
