欧盟GMP中英文对照docx.docx
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欧盟GMP中英文对照docx
EuropeanUnion
药品生产质量管理规范
GUIDETOGOODMANUFACTURINGPRACTICEFORMEDICINALPRODUCTS
TherulesgoverningmedicinalproductsintheEuropeanUnion药品生产质量管理规范
第一章质量管理
CHAPTER1:
QUALITYMANAGEMENT
原则5
Principle5
质量保证5
QualityAssurance5
药品生产质量管理规范（GMP）7
GoodManufacturingPracticeforMedicinal
Products7
质量控制（QC）9
QualityControl9
产品质量回顾10
第二章人员
CHAPTER2:
PERSONNEL11
原则11
Principle11
通则12
General12
关键人员12
KeyPersonnel12
培训12
Training15
人员卫生16
PersonnelHygiene16
第三章厂房和设备
CHAPTER3:
PREMISESANDEQUIPMENT18
原则18
Principle18
厂房18
Premises18
通则18
General18
生产区19
1
TherulesgoverningmedicinalproductsintheEuropeanUnion
药品生产质量管理规范
ProductionArea........................................................................................................................
19
贮存区
21
....................................................................................................................................
StorageArea
21
.............................................................................................................................
22
质量控制区
.......................................................................................................................
QualityControlArea
22
22
附助区
.................................................................................................................................
AncillaryAreas
22
23
设备
......................................................................................................................................
Equipment
23
第四章
文件
24
CHAPTER4:
DOCUMENTATION
24
原则
......................................................................................................................................
Principle
24
25
通则
......................................................................................................................................
General
25
27
文件要求
.............................................................................................................................
DocumentsRequired
27
27
Specifications
Specificationsforstartingandpackaging
27
materials
SpecificationsforIntermediateandBulk
27
Products
SpecificationsforFinished
Products......................................................................................
28
ManufacturingFormulaeandProcessing
Instructions...........................................................
28
PackagingInstructions............................................................................................................
30
BatchProcessing
Records.......................................................................................................
31
BatchPackaging
32
Records.......................................................................................................
Proceduresand
33
Records
.................
Receipt
34
Sampling.............................................................................................................................................................................................................................................................................
34
35
Testing
35
Other
2
TherulesgoverningmedicinalproductsintheEuropeanUnion药品生产质量管理规范
第五章生产
CHAPTER5:
PRODUCTION
36
.....................................................
原则
36
........................................
..............................................................................................
Principle...................................................................................................................................
36
36
通则
........................................
..............................................................................................
General.....................................................................................................................................
36
39
生产过程中对交叉污染的预防
....................................................................................
PreventionofCross-contaminationin
Production..................................................................
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
..........................................................................
Processing
Operations:
Intermediate
and
Bulk
Products........................................................
42
包装材料........................................
.....................................................................................43
PackagingMaterials..........................
.....................................................................................43
包装操作
44
........................................
.....................................................................................
Packaging
Operations........................
44
.....................................................................................
成品
46
........................................
..............................................................................................
FinishedProducts.....................
..............................................................................................46
不合格、回收料和退货物料........................................................................................
46
Rejected,RecoveredandReturned
Materials........................................................................
46
第六章质量控制
CHAPTER6:
QUALITYCONTROL
...................................................................................48
原则........................................
..............................................................................................48
Principle...................................
..............................................................................................48
3
TherulesgoverningmedicinalproductsintheEuropeanUnion
药品生产质量管理规范
通则........................................
..............................................................................................48
48
General...................................................................................................................................
质量控制实验室规范
49
......................................................................................................
GoodQualityControlLaboratory
Practice.....................................................................................................................................................................................................
49
49
Documentation
50
Sampling...................................
.............................................................................................
52
Testing...................................................................................................................................
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
升级会员 