9A文欧盟GMP中英文对照.docx
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9A文欧盟GMP中英文对照.docx
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9A文欧盟GMP中英文对照
EuropeanUnion
药品生产质量管理规范
GUIDETOGOODMANUFACTURINGPRACTICEFORMEDICINALPRODUCTS
第一章质量管理
CHAPTER1:
QUALITYMANAGEMENT
原则.....................................................................................................................................................5
Principle.....................................................................................................................................................5
质量保证...........................................................................................................................................5
QualityAssurance.....................................................................................................................................5
药品生产质量管理规范(GMP).................................................................................................7
GoodManufacturingPracticeforMedicinalProducts..............................................................................7
质量控制(QC)...................................................................................................................................9
QualityControl..........................................................................................................................................9
产品质量回顾..................................................................................................................................10
第二章人员
CHAPTER2:
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.....................................................
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