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1、21CFRPart210&211PART210CURRENTGOODMANUFACTURINGPRACTICEINMANUFACTURING,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)Theregulationssetforthinthispartandinparts211through226ofthi
2、schaptercontaintheminimumcurrentgoodmanufacturingpracticeformethodstobeusedin,andthefacilitiesorcontrolstobeusedfor,themanufacture,processing,packing,orholdingofadrugtoassurethatsuchdrugmeetstherequirementsoftheactastosafety,andhastheidentityandstrengthandmeetsthequalityandpuritycharac
3、teristicsthatitpurportsorisrepresentedtopossess.(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)Thefailuretocomplywithanyregulationsetforthinthispartandinparts211through226ofthischapt
4、erinthemanufacture,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
5、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),asdefinedin127
6、1.3(d)ofthischapter,thataredrugs(subjecttoreviewunderanapplicationsubmittedundersection505oftheactorunderabiologicalproductlicenseapplicationundersection351ofthePublicHealthServiceAct),aresubjecttothedonor-eligibilityandapplicablecurrentgoodtissuepracticeproceduressetforthinpart1271sub
7、partsCandDofthischapter,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