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第一章质量管理一、原则Principle生产许可证持有厂家只能生产医药产品，以确保药品符合其预期的使用目的，符合销售许可证的要求，并不因药品安全性、质量或药效方面的问题而给患者带来风险。达到这一质量目标是高层管理者的责任，同时也需要公司各部门、各层次的职员以及公司的供应商和销售商的参与并承担义务。为了确保达到该质量目标，必须全面设计并正确贯彻实施包括GMP与质量控制(QC)在内的质量保证(QA)体系。该体系应用文件明文规定并对其有效性加以监控。质量保证体系的所有部门都必须充分配备胜任的人员，适宜足够的厂房、设备及设施。与此同时，生产许可证持有者及受权人员具有另外的法律责任。TheholderofaManufacturingAuthorisationmustmanufacturemedicinalproductssoastoensurethattheyarefitfortheirintendeduse,complywiththerequirementsoftheMarketingAuthorisationanddonotplacepatientsatriskduetoinadequatesafety,qualityorefficacy.Theattainmentofthisqualityobjectiveistheresponsibilityofseniormanagementandrequirestheparticipationandcommitmentbystaffinmanydifferentdepartmentsandatalllevelswithinthecompany,bythecompany’ssuppliersandbythedistributors.ToachievethequalityobjectiveinareliablemannertheremustbeacomprehensivelydesignedandcorrectlyimplementedsystemofQualityAssuranceincorporatingGoodManufacturingPracticeandthusQualityControl.Itshouldbefullydocumentedanditseffectivenessmonitored.AllpartsoftheQualityAssurancesystemshouldbeadequatelyresourcedwithcompetentpersonnel,andsuitableandsufficientpremises,equipmentandfacilities.ThereareadditionallegalresponsibilitiesfortheholderoftheManufacturingAuthorisationandfortheQualifiedPerson(s).1.1质量保证、GMP和质量控制的基本概念是内在相互联系的。这里叙述的主要目的是强调它们之间的关系以及药品生产和控制中的重要性。ThebasicconceptsofQualityAssurance,GoodManufacturingPracticeandQualityControlareinter-related.Theyaredescribedhereinordertoemphasisetheirrelationshipsandtheirfundamentalimportancetotheproductionandcontrolofmedicinalproducts.二、质量保证QualityAssurance1.2质量保证是一个宽泛的概念，它包括影响产品质量的所有问题，是确保药品质量符合预期使用目的而进行组织管理的总和。因此质量保证是由GMP本规范之外的其他因素所组成。QualityAssuranceisawiderangingconceptwhichcoversallmatterswhichindividuallyorcollectivelyinfluencethequalityofaproduct.Itisthetotalsumoftheorganisedarrangementsmadewiththeobjectofensuringthatmedicinalproductsareofthequalityrequiredfortheirintendeduse.QualityAssurancethereforeincorporatesGoodManufacturingPracticeplusotherfactorsoutsidethescopeofthisGuide.质量保证体系对于药品的生产而言，应保证：ThesystemofQualityAssuranceappropriateforthemanufactureofmedicinalproductsshouldensurethat:(1)药品的设计与开发应按照GMP和GLP的要求进行；medicinalproductsaredesignedanddevelopedinawaythattakesaccountoftherequirementsofGoodManufacturingPracticeandGoodLaboratoryPractice;(2)生产和控制操作应有明确规定，并采用GMP；productionandcontroloperationsareclearlyspecifiedandGoodManufacturingPracticeadopted;(3)明确规定管理职责；managerialresponsibilitiesareclearlyspecified;(4)安排生产、供应和使用正确的原、辅、包材料；arrangementsaremadeforthemanufacture,supplyanduseofthecorrectstartingandpackagingmaterials;(5)对中间产品进行必要的控制、进行其他任何过程控制和验证；allnecessarycontrolsonintermediateproducts,andanyotherin-processcontrolsandvalidationsarecarriedout;(6)按照规定的程序，正确地加工与核查成品；thefinishedproductiscorrectlyprocessedandchecked,accordingtothedefinedprocedures;(7)在受权人确认批产品按照销售许可证和其他与药品生产、检验和释放有关的法规要求进行生产和质量控制，并签发合格证之前，药品不得销售或供应；medicinalproductsarenotsoldorsuppliedbeforeaQualifiedPersonhascertifiedthateachproductionbatchhasbeenproducedandcontrolledinaccordancewiththerequirementsoftheMarketingAuthorisationandanyotherregulationsrelevanttotheproduction,controlandreleaseofmedicinalproducts;(8)尽可能对药品贮存、销售及随后的处理做出满意的安排，以保证药品在货架寿命期内的质量；satisfactoryarrangementsexisttoensure,asfaraspossible,thatthemedicinalproductsarestored,distributedandsubsequentlyhandledsothatqualityismaintainedthroughouttheirshelflife;(9)建立自检和/或质量审计程序，定期对质量保证体系的有效性和适用性进行评价。thereisaprocedureforSelf-Inspectionand/orqualityauditwhichregularlyappraisestheeffectivenessandapplicabilityoftheQualityAssurancesystem.三、药品生产质量管理规范(GMP)GoodManufacturingPracticeforMedicinalProducts1.3GMP是质量保证的一部分，它确保药品始终按照适合于其使用目的的质量标准进行生产和控制，并符合销售许可证的要求。1.3GoodManufacturingPracticeisthatpartofQualityAssurancewhichensuresthatproductsareconsistentlyproducedandcontrolledtothequalitystandardsappropriatetotheirintendeduseandasrequiredbytheMarketingAuthorisationorproductspecification.GMP涉及生产和质量控制，其基本要求如下：GoodManufacturingPracticeisconcernedwithbothproductionandqualitycontrol.ThebasicrequirementsofGMParethat:(1)所有生产工艺应有明确规定，根据经验进行系统的审核，并证明能够始终如一地生产出符合质量标准的药品。allmanufacturingprocessesareclearlydefined,systematicallyreviewedinthelightofexperienceandshowntobecapableofconsistentlymanufacturingmedicinalproductsoftherequiredqualityandcomplyingwiththeirspecifications;(2)应对生产工艺的关键步骤和工艺的重要变更进行验证。criticalstepsofmanufacturingprocessesandsignificantchangestotheprocessarevalidated;(3)提供所有GMP必需的设施，包括：allnecessaryfacilitiesforGMPareprovidedincluding:a.资历合格并经过培训的人员；appropriatelyqualifiedandtrainedpersonnel;b.适宜的厂房和空间；adequatepremisesandspace;c.合适的设备及配套设施；suitableequipmentandservices;d.正确的物料、容器和标签；correctmaterials,containersandlabels;e.经批准的程序和指令；approvedproceduresandinstructions;f.合适的贮存设施和运输设备。suitablestorageandtransport;(4)指令和程序应使用清楚明了的语言，并适用于所提供的设施。instructionsandproceduresarewritteninaninstructionalforminclearandunambiguouslanguage,specificallyapplicabletothefacilitiesprovided;(5)操作者应经过培训，以便按正确地按照程序进行操作。operatorsaretrainedtocarryoutprocedurescorrectly;(6)生产过程中采用手工和/或记录仪填写记录，以证明已完成的所有生产步骤是按照确定的程序和指令要求进行的，产品达到预期的质量和数量。任何重要偏差都应详细记录和调查。rec