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1、PART210CURRENTGOODMANUFACTURINGPRACTICEINMANUFACTURING,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)Theregulationssetforthinthispartandinparts211through226ofthisch
2、aptercontaintheminimumcurrentgoodmanufacturingpracticeformethodstobeusedin,andthefacilitiesorcontrolstobeusedfor,themanufacture,processing,packing,orholdingofadrugtoassurethatsuchdrugmeetstherequirementsoftheactastosafety,andhastheidentityandstrengthandmeetsthequalityandpu
3、ritycharacteristicsthatitpurportsorisrepresentedtopossess.(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)Thefailuretocomplywithanyregulationsetforthinthispartandinparts2
4、11through226ofthischapterinthemanufacture,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
5、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,andcellu
6、larandtissue-basedproducts(HCT/Ps),asdefinedin1271.3(d)ofthischapter,thataredrugs(subjecttoreviewunderanapplicationsubmittedundersection505oftheactorunderabiologicalproductlicenseapplicationundersection351ofthePublicHealthServiceAct),aresubjecttothedonor-eligibilityandappl
7、icablecurrentgoodtissuepracticeproceduressetforthinpart1271subpartsCandDofthischapter,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50
8、5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
