药用产品GMP指南第一部分翻译

PHARMACEUTICALINSPECTIONCONVENTIONPHARMACEUTICALINSPECTIONCO-OPERATIONSCHEME药品检验公约药品检验合作计划GUIDETOGOODMANUFACTURINGPRACTICEFORMEDICINALPRODUCTSPARTI药用产品良好生产规范指南第一部分目录第一章质量管理.............................................................................................................................2第二章人员.....................................................................................................................................11第三章厂房设施...........................................................................................................................17第四章文件...................................................................................................................................25第五章生产...................................................................................................................................41第六章质量控制.............................................................................................................................53第七章委托生产与委托检验.......................................................................................................62第八章产品投诉和召回...............................................................................................................66第九章自检...................................................................................................................................69CHAPTER1第一章质量管理QUALITYMANAGEMENTPRINCIPLE原则Theholderofamanufacturingauthorisationmustmanufacturemedicinalproductssoastoensurethattheyarefitfortheirintendeduse,complywiththerequirementsoftheMarketingAuthorisationanddonotplacepatientsatriskduetoinadequatesafety,qualityorefficacy.Theattainmentofthisqualityobjectiveistheresponsibilityofseniormanagementandrequirestheparticipationandcommitmentbystaffinmanydifferentdepartmentsandatalllevelswithinthecompany,bythecompany’ssuppliersandbythedistributors.ToachievethequalityobjectivereliablytheremustbeacomprehensivelydesignedandcorrectlyimplementedsystemofQualityAssuranceIncorporatingGoodManufacturingPractice,andthusQualityControlandQualityRiskManagement.Itshouldbefullydocumentedanditseffectivenessmonitored.AllpartsoftheQualityAssurancesystemsshouldbeadequatelyresourcedwithcompetentpersonnel,andsuitableandsufficientpremises,equipmentandfacilities.Thereareadditionallegalresponsibilitiesfortheholderofthemanufacturingauthorisationandfortheauthorisedperson(s).生产许可证持有人必须生产药品，从而确保药品适合预期用途、符合相应的上市许可证或临床试验许可证要求，不因为安全性问题、质量问题或有效性问题而把患者置于风险之中。实现上述质量目标是公司高级管理人员的职责，并要求公司的供应商、销售商，公司内所有各级员工与许多不同部门的员工共同参与、一起努力。要可靠地实现这一质量目标，必须综合设计一个整合药品生产质量管理规范（GMP）和质量控制、质量风险管理的制药质量保证体系并正确实施。质量体系应当全面文件化，并监察其有效性。整个制药质量体系应当配备充足的具有资质的人员，以及充分并适用的建筑物、设备和设施。生产许可证持有人以及质量受权人有额外的法律责任。ThebasicconceptsofQualityAssurance,GoodManufacturingPractice,QualityControlandQualityRiskManagementareinter-related.Theyaredescribedhereinordertoemphasisetheirrelationshipsandtheirfundamentalimportancetotheproductionandcontrolofmedicinalproducts.质量保证、药品生产质量管理规范、质量控制以及质量风险管理的基本概念是相互关联的。在这里对其进行描述是为了强调它们之间的联系以及其对药品生产和控制的重要性。QUALITYASSURANCE质量保证1.1QualityAssuranceisawide-rangingconcept,whichcoversallmatters,whichindividuallyorcollectivelyinfluencethequalityofaproduct.Itisthesumtotaloftheorganisedarrangementsmadewiththeobjectiveofensuringthatmedicinalproductsareofthequalityrequiredfortheirintendeduse.QualityAssurancethereforeincorporatesGoodManufacturingPracticeplusotherfactorsoutsidethescopeofthisGuide.质量保证是一个宽泛的概念，涵盖所有因素，这些因素单独或共同影响产品质量。质量保证是为了保证药品质量符合预期用途，而进行的有组织的安排的总和。因此，质量保证中包含着药品生产质量管理规范以及本指南的范围内的其他因素。ThesystemofQualityAssuranceappropriateforthemanufactureofmedicinalproductsshouldensurethat:一个适当的质量保证体系应当确保：i.medicinalproductsaredesignedanddevelopedinawaythattakesaccountoftherequirementsofGoodManufacturingPractice;药品的设计和开发应考虑药品生产质量管理规范的要求；ii.productionandcontroloperationsareclearlyspecifiedandGoodManufacturingPracticeadopted;对生产和控制操作进行明确规定，并符合药品生产质量管理规范的要求；iii.managerialresponsibilitiesareclearlyspecified;明确规定管理职责；iv.arrangementsaremadeforthemanufacture,supplyanduseofthecorrectstartingandpackagingmaterials;对下述活动均有协议约束：生产、供应、使用正确的起始物料与包装材料。v.allnecessarycontrolsonintermediateproducts,andanyotherinprocesscontrolsandvalidationsarecarriedout;对中间产品以及其他任何中间过程控制与验证实施所有必要的控制；vi.thefinishedproductiscorrectlyprocessedandchecked,accordingtothedefinedprocedures;成品根据确定的程序进行正确生产和检测；vii.medicinalproductsarenotsoldorsuppliedbeforeanauthorisedpersonhascertifiedthateachproductionbatchhasbeenproducedandcontrolledinaccordancewiththerequirementsofthemarketingauthorisationandanyotherregulationsrelevanttotheproduction,controlandreleaseofmedicinalproducts;质量受权人需签发证明以确认每一批次药品的生产和控制均符合上市许可要求以及与药品生产、控制和放行相关的任何其他法规要求，未经质量受权人签发证明的药品不得销售或供货；viii.satisfactoryarrangementsexisttoensure,asfaraspossible,thatthemedicinalproductsarestored,distributedandsubsequentlyhandledsothatqualityismaintainedthroughouttheirshelflife;药品贮存、发运和后续处理确保有满意的管理规程，从而尽量保证药品货架期内的质量ix.thereisaprocedureforself-inspectionand/orqualityaudit,whichregularlyappraisestheeffectivenessandapplicabilityofthequalityassurancesystem.有自检和/或质量审计规程，以定期评价质量保证体系的有效性与适用性。GOODMANUF