欧盟GMP中英文对照Word格式文档下载.docx
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PERSONNEL................................11
原则..................................................................11
Principle..................................................................11
通则..............................................................12
General...................................................................12
关键人员........................................12
KeyPersonnel......................................12
培训...........................................12
Training..................................15
人员卫生.............................................16
PersonnelHygiene...................................16
第三章厂房和设备
CHAPTER3:
PREMISESANDEQUIPMENT................18
原则..................18
Principle.......................................18
厂房.................................18
Premises..............................................18
通则...........................................18
General.................................................18
生产区................................................19
ProductionArea.........................19
贮存区............................................21
StorageArea.......................................21
质量控制区...................................22
QualityControlArea.............................22
附助区...............................................22
AncillaryAreas.......................................22
设备....................................................23
Equipment...............................................23
第四章
文件
CHAPTER4:
DOCUMENTATION.....24
原则......................................................24
Principle..................................................24
通则......................................................25
General...................................................25
文件要求............................................27
DocumentsRequired..............................27
Specifications.........................................27
Specificationsforstartingandpackagingmaterials....27
SpecificationsforIntermediateandBulkProducts............27
SpecificationsforFinishedProducts.............................28
ManufacturingFormulaeandProcessingInstructions.....28
PackagingInstructions.......................30
BatchProcessingRecords......................31
BatchPackagingRecords......................32
ProceduresandRecords..........................33
Receipt.....................................................34
Sampling................................................34
Testing......................................................35
Other.......................................................35
第五章生产
CHAPTER5:
PRODUCTION...............36
原则.......................................................36
Principle...................................................36
通则......................................................36
General.....................................................36
生产过程中对交叉污染的预防....................39
PreventionofCross-contaminationinProduction......39
验证.............................................40
Validation..............................................40
原料......................................................41
StartingMaterials....................................41
生产操作：
中间产品和待包装产品.....................42
ProcessingOperations:
IntermediateandBulkProducts...................42
包装材料............................................43
PackagingMaterials...............................43
包装操作..................................44
PackagingOperations.............................44
成品.....................................................46
FinishedProducts..................................46
不合格、回收料和退货物料...............46
Rejected,RecoveredandReturnedMaterials..............46
第六章质量控制
CHAPTER6:
QUALITYCONTROL.....48
原则......................................................48
Principle.................................................48
通则......................................................48
General.................................................48
质量控制实验室规范.................49
GoodQualityControlLaboratoryPractice........49
Documentation......................................49
Sampling...............................................50
Testing...................................................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.....................................55
Principle..................................................55
通则.....................................................56
General...................................................56
委托方..................................................56
TheContractGiver................................56
受托方.................................................57
TheContractAcceptor.........................57
合同..................................................58
TheContract..........................................58
第八章投诉与召回
CHAPTER8:
COMPLAINTSANDPRODUCTRECALL.............59
原则.......................................59
Principle................................................59
投诉......................................59
Complaints..................................59
召回....................................60
Recalls..........................................60
第九章自查
CHAPTER9:
SELFINSPECTION.........61
原则................................61
Principle....................................61
附件8
原辅料和包装材料的取样
ANNEX8SAMPLINGOFSTARTINGANDPACKAGINGMATERIALS.......................63
原则................................63
Principle........................................63
人员.....................................63
Personnel.................................63
原辅料..............................................63
Startingmaterials................64
包装材料.........................................65
Packagingmaterial......................65
欧盟GMP中英文对照02
第一章
质量管理
CHAPTER1QUALITYMANAGEMENT
Principle
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.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;
v
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