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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
ProductionArea........................................................................................................................
19
贮存区
21
....................................................................................................................................
StorageArea
.............................................................................................................................
22
质量控制区
.......................................................................................................................
QualityControlArea
附助区
.................................................................................................................................
AncillaryAreas
23
设备
......................................................................................................................................
Equipment
第四章
文件
24
CHAPTER4:
DOCUMENTATION
原则
Principle
25
通则
General
27
文件要求
DocumentsRequired
Specifications
Specificationsforstartingandpackaging
materials
SpecificationsforIntermediateandBulk
Products
SpecificationsforFinished
Products......................................................................................
28
ManufacturingFormulaeandProcessing
Instructions...........................................................
PackagingInstructions............................................................................................................
30
BatchProcessing
Records.......................................................................................................
31
BatchPackaging
32
Records.......................................................................................................
Proceduresand
33
Records
.................
Receipt
34
Sampling.............................................................................................................................................................................................................................................................................
35
Testing
Other
2
第五章生产
CHAPTER5:
PRODUCTION
36
.....................................................
........................................
..............................................................................................
Principle...................................................................................................................................
General.....................................................................................................................................
39
生产过程中对交叉污染的预防
....................................................................................
PreventionofCross-contaminationin
Production..................................................................
验证........................................
..............................................................................................40
Validation.................................
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........................................................
包装材料........................................
.....................................................................................43
PackagingMaterials..........................
包装操作
44
.....................................................................................
Packaging
Operations........................
成品
46
FinishedProducts.....................
..............................................................................................46
不合格、回收料和退货物料........................................................................................
Rejected,RecoveredandReturned
Materials........................................................................
第六章质量控制
CHAPTER6:
QUALITYCONTROL
...................................................................................48
原则........................................
..............................................................................................48
Principle...................................
3
通则........................................
48
General...................................................................................................................................
质量控制实验室规范
49
......................................................................................................
GoodQualityControlLaboratory
Practice.....................................................................................................................................................................................................
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
55
56
General.....................................
委托方
....................................
TheContractGiver....................
............................................................................................
受托方
57
TheContractAcceptor
合同
58
TheContract.............................
第八章投诉与召回
升级会员 