欧盟GMP中英文对照

内容目录

目     录
第一章 质量管理
CHAPTER 1: QUALITY MANAGEMENT
原则............................................................ ..................................................... ............ ........................5
Principle.....................................................................................................................................................5
质量保证................................................................... .............. .......................................................... 5
Quality Assurance..................................................................................................................................... 5
药品生产质量管理规范(GMP).................................................................................................7
Good Manufacturing Practice for Medicinal Products..............................................................................7
质量控制(QC) ...................................................................................................................................9
Quality Control....................... ...................................................................................................................9
产品质量回顾....................... ....................... ....................................................................................10

第二章人员
CHAPTER 2:  PERSONNEL...................................................................................... ........11
原则......................................................................................................................................11
Principle..................................................................................................................................11
通则................................................................................................................................... 12
General...................................................................................................................... .............12
关键人员................................................................................................................... ............................12
Key Personnel...........................................................................................................................................12
培训.......................................................................................................................................................... 12
Training..................................................................................................................... .............15
人员卫生................................................................................................................................................16
Personnel Hygiene...................................................................................................................................16

第三章厂房和设备
CHAPTER 3: PREMISES AND EQUIPMENT
原则........................................................................................................................................18
Principle....................................................................................................................................18
厂房.........................................................................................................................................18
Premises....................................................................................................................................18
通则.........................................................................................................................................18
General......................................................................................................................................18
生产区....................................................................................................................................19
Production Area........................................................................................................................19贮存区....................................................................................................................................21
Storage Area.............................................................................................................................21
质量控制区.......................................................................................................................22
Quality Control Area.............................................................................................................22
附助区.................................................................................................................................22
Ancillary Areas......................................................................................................................22
设备......................................................................................................................................23
Equipment..............................................................................................................................23

第四章  文件
CHAPTER 4: DOCUMENTATION.....................................................................................24
原则......................................................................................................................................24
Principle.................................................................................................................................24
通则......................................................................................................................................25
General...................................................................................................................................25
文件要求.............................................................................................................................27
Documents Required..............................................................................................................27
Specifications..........................................................................................................................27
Specifications for starting and packaging materials...............................................................27
Specifications for Intermediate and Bulk Products................................................................27
Specifications for Finished Products......................................................................................28
Manufacturing Formulae and Processing Instructions...........................................................28
Packaging Instructions............................................................................................................30
Batch Processing Records.......................................................................................................31
Batch Packaging Records. ......................................................................................................32
Procedures and Records........................................................................................ .................33
Receipt.....................................................................................................................................34
Sampling..................................................................................................................................34
Testing.....................................................................................................................................35
Other........................................................................................................................................35

第五章 生产
CHAPTER 5: 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
Prevention of Cross-contamination in Production..................................................................39
验证........................................ ..............................................................................................40
Validation................................. ..............................................................................................40
原料........................................ ..............................................................................................41
Starting Materials..................... ..............................................................................................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
Packaging Materials.......................... .....................................................................................43
包装操作........................................ .....................................................................................44
Packaging Operations........................ .....................................................................................44
成品........................................ ..............................................................................................46
Finished Products..................... ..............................................................................................46
不合格、回收料和退货物料........................................................................................46
Rejected, Recovered and Returned Materials........................................................................46

第六章质量控制
CHAPTER 6: QUALITY CONTROL...................................................................................48
原则........................................ ..............................................................................................48
Principle................................... ..............................................................................................48
通则........................................ ..............................................................................................48
General... ................................................................................................................................48
质量控制实验室规范......................................................................................................49
Good Quality Control Laboratory Practice.............................................................................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
CHAPTER 7: CONTRACT MANUFACTURE AND ANALYSIS......................................55
原则........................................ ..............................................................................................55
Principle................................... ..............................................................................................55
通则........................................ ..............................................................................................56
General..................................... ..............................................................................................56
委托方.................................... ..............................................................................................56
The Contract Giver.................... ............................................................................................56
受托方.................................... .............................................................................................57
The Contract Acceptor.............. .............................................................................................57
合同........................................ ..............................................................................................58
The Contract............................. .............................................................................................58

第八章 投诉与召回
CHAPTER 8: COMPLAINTS AND PRODUCT RECALL..................................................59
原则........................................ ..............................................................................................59
Principle.................................... ..............................................................................................59
投诉........................................ ..............................................................................................59
Complaints................................ ..............................................................................................59
召回........................................................................................................................................60
Recalls......................................................................................................................................60

第九章自查
CHAPTER 9: SELF INSPECTION........................................................................................61
原则.......................................................................................................................................61
Principle..................................................................................................................................61

附件8 原辅料和包装材料的取样
ANNEX8 SAMPLING OF STARTING AND PACKAGING MATERIALS.......................63
原则.......................................................................................................................................63
Principle..................................................................................................................................63
人员.......................................................................................................................................63
Personnel.................................................................................................................................63
原辅料...................................................................................................................................63
Starting materials.....................................................................................................................64
包装材料...............................................................................................................................65
Packaging material...................................................................................................................65

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欧盟GMP中英文对照