欧盟GMP中英文对照

TherulesgoverningmedicinalproductsintheEuropeanUnion药品生产质量管理 规范 编程规范下载gsp规范下载钢格栅规范下载警徽规范下载建设厅规范下载 PAGEPAGE65EuropeanUnion药品生产质量管理规范GUIDETOGOODMANUFACTURINGPRACTICEFORMEDICINALPRODUCTS 目录 工贸企业有限空间作业目录特种设备作业人员作业种类与目录特种设备作业人员目录1类医疗器械目录高值医用耗材参考目录 第一章质量管理CHAPTER1:QUALITYMANAGEMENT原则.....................................................................................................................................................5Principle.....................................................................................................................................................5质量保证...........................................................................................................................................5QualityAssurance.....................................................................................................................................5药品生产质量管理规范(GMP).................................................................................................7GoodManufacturingPracticeforMedicinalProducts..............................................................................7质量控制(QC)...................................................................................................................................9QualityControl..........................................................................................................................................9产品质量回顾..................................................................................................................................10第二章人员CHAPTER2:PERSONNEL..............................................................................................11HYPERLINK\l"_Toc91044313"原则......................................................................................................................................11Principle..................................................................................................................................11HYPERLINK\l"_Toc91044314"通则...................................................................................................................................12General...................................................................................................................................12关键人员...............................................................................................................................................12KeyPersonnel...........................................................................................................................................12培训..........................................................................................................................................................12Training..................................................................................................................................15人员卫生................................................................................................................................................16PersonnelHygiene...................................................................................................................................16第三章厂房和设备CHAPTER3:PREMISESANDEQUIPMENT..............................................................................18原则........................................................................................................................................18Principle....................................................................................................................................18厂房.........................................................................................................................................18Premises....................................................................................................................................18通则.........................................................................................................................................18General......................................................................................................................................18生产区....................................................................................................................................19ProductionArea........................................................................................................................19贮存区....................................................................................................................................21StorageArea.............................................................................................................................21质量控制区.......................................................................................................................22QualityControlArea.............................................................................................................22附助区.................................................................................................................................22AncillaryAreas......................................................................................................................22设备......................................................................................................................................23Equipment..............................................................................................................................23第四章文件CHAPTER4:DOCUMENTATION.....................................................................................24原则......................................................................................................................................24Principle.................................................................................................................................24通则......................................................................................................................................25General...................................................................................................................................25文件要求.............................................................................................................................27DocumentsRequired..............................................................................................................27Specifications..........................................................................................................................27Specificationsforstartingandpackagingmaterials...............................................................27SpecificationsforIntermediateandBulkProducts................................................................27SpecificationsforFinishedProducts......................................................................................28ManufacturingFormulaeandProcessingInstructions...........................................................28PackagingInstructions............................................................................................................30BatchProcessingRecords.......................................................................................................31BatchPackagingRecords.......................................................................................................32ProceduresandRecords.........................................................................................................33Receipt.....................................................................................................................................34Sampling..................................................................................................................................34Testing.....................................................................................................................................35Other........................................................................................................................................35第五章生产CHAPTER5:PRODUCTION..............................................................................................36原则......................................................................................................................................36Principle...................................................................................................................................36通则......................................................................................................................................36General.....................................................................................................................................36生产过程中对交叉污染的预防....................................................................................39PreventionofCross-contaminationinProduction..................................................................39验证......................................................................................................................................40Validation...............................................................................................................................40原料......................................................................................................................................41StartingMaterials...................................................................................................................41生产操作：中间产品和待包装产品..........................................................................42ProcessingOperations:IntermediateandBulkProducts........................................................42包装材料.............................................................................................................................43PackagingMaterials...............................................................................................................43包装操作.............................................................................................................................44PackagingOperations.............................................................................................................44成品......................................................................................................................................46FinishedProducts...................................................................................................................46不合格、回收料和退货物料........................................................................................46Rejected,RecoveredandReturnedMaterials........................................................................46第六章质量控制CHAPTER6:QUALITYCONTROL...................................................................................48原则......................................................................................................................................48Principle.................................................................................................................................48通则......................................................................................................................................48General...................................................................................................................................48质量控制实验室规范......................................................................................................49GoodQualityControlLaboratoryPractice.............................................................................49Documentation........................................................................................................................49Sampling................................................................................................................................50Testing...................................................................................................................................52销售产品的稳定性考察.................................................................................................54第七章委托生产与委托检验CHAPTER7:CONTRACTMANUFACTUREANDANALYSIS......................................55原则......................................................................................................................................55Principle.................................................................................................................................55通则......................................................................................................................................56General...................................................................................................................................56委托方..................................................................................................................................56TheContractGiver................................................................................................................56受托方.................................................................................................................................57TheContractAcceptor...........................................................................................................57合同......................................................................................................................................58TheContract..........................................................................................................................58第八章投诉与召回CHAPTER8:COMPLAINTSANDPRODUCTRECALL..................................................59原则......................................................................................................................................59Principle..................................................................................................................................59投诉......................................................................................................................................59Complaints..............................................................................................................................59召回........................................................................................................................................60Recalls......................................................................................................................................60第九章自查CHAPTER9:SELFINSPECTION........................................................................................61原则.......................................................................................................................................61Principle..................................................................................................................................61附件8原辅料和包装材料的取样ANNEX8SAMPLINGOFSTARTINGANDPACKAGINGMATERIALS.......................63原则.......................................................................................................................................63Principle..................................................................................................................................63人员.......................................................................................................................................63Personnel.................................................................................................................................63原辅料...................................................................................................................................63Startingmaterials.....................................................................................................................64包装材料...............................................................................................................................65Packagingmaterial...................................................................................................................65第一章质量管理CHAPTER1QUALITYMANAGEMENTPrinciple原则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 领导形象设计圆作业设计ao工艺污水处理厂设计附属工程施工组织设计清扫机器人结构设计 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 关于下班后关闭电源的规定党章中关于入党时间的规定公务员考核规定下载规定办法文件下载宁波关于闷顶的规定 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.ToachievethequalityobjectivereliablytheremustbeacomprehensivelydesignedandcorrectlyimplementedsystemofQualityAssuranceincorporatingGoodManufacturingPracticeandthusQualityControl.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。1.1.ThebasicconceptsofQualityAssurance,GoodManufacturingPracticeandQualityControlareinter-related.Theyaredescribedhereinordertoemphasisetheirrelationshipsandtheirfundamentalimportancetotheproductionandcontrolofmedicinalproducts.QualityAssurance质量保证1.2.QualityAssuranceisawiderangingconceptwhichcoversallmatterswhichindividuallyorcollectivelyinfluencethequalityofaproduct.Itisthesumtotaloftheorganizedarrangementsmadewiththeobjectofensuringthatmedicinalproductsareofthequalityrequiredfortheirintendeduse.QualityAssurancethereforeincorporatesGoodManufacturingPracticeplusotherfactorsoutsidethescopeofthisGuide.1.2.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。ThesystemofQualityAssuranceappropriateforthemanufactureofmedicinalproductsshouldensurethat:质量保证体系对于药品的生产而言，应保证：i.medicinalproductsaredesignedanddevelopedinawaythattakesaccountoftherequirementsofGoodManufacturingPracticeandGoodLaboratoryPractice;i.药品的设计与开发应按照GMP和GLP的要求进行；ii.productionandcontroloperationsareclearlyspecifiedandGoodManufacturingPracticeadopted;ii.生产和控制操作应有明确规定，并采用GMP；iii.managerialresponsibilitiesareclearlyspecified;iii.明确规定管理职责；iv.arrangementsaremadeforthemanufacture,supplyanduseofthecorrectstartingandpackagingmaterials;iv.安排生产、供应和使用正确的原、辅、包材料；v.allnecessarycontrolsonintermediateproducts,andanyotherin-processcontrolsandvalidationsarecarriedout;v.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；vi.thefinishedproductiscorrectlyprocessedandchecked,accordingtothedefinedprocedures;vi.按照规定的程序，正确地加工与核查成品；vii.medicinalproductsarenotsoldorsuppliedbeforeaQualifiedPersonhascertifiedthateachproductionbatchhasbeenproducedandcontrolledinaccordancewiththerequirementsoftheMarketingAuthorisationandanyotherregulationsrelevanttotheproduction,controlandreleaseofmedicinalproducts;vii.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；viii.satisfactoryarrangementsexisttoensure,asfaraspossible,thatthemedicinalproductsarestored,distributedandsubsequentlyhandledsothatqualityismaintainedthroughouttheirshelflife;viii.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；ix.thereisaprocedureforSelf-Inspectionand/orqualityauditwhichregularlyappraisestheeffectivenessandapplicabilityoftheQualityAssurancesystem.ix.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。GoodManufacturingPracticeforMedicinalProducts(GMP)药品生产质量管理规范(GMP)1.3GoodManufacturingPracticeisthatpartofQualityAssurancewhichensuresthatproductsareconsistentlyproducedandcontrolledtothequalitystandardsappropriatetotheirintendeduseandasrequiredbytheMarketingAuthorisationorproductspecification.1.3GMP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 excel标准偏差excel标准偏差函数exl标准差函数国标检验抽样标准表免费下载红头文件格式标准下载 进行生产和控制，并符合销售许可证的要求。GoodManufacturingPracticeisconcernedwithbothproductionandqualitycontrol.Thebasicr