欧盟GMP中英文对照.docx

欧盟GMP中英文对照.docx

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欧盟GMP中英文对照

EuropeanUnion

欧阳光明（2021.03.07）

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

Principle..................................................................................................................................11

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....................................................................................................