欧盟GMP中英文对照
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European Union
药品生产质量管理规范
GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS
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
......................................................................................................................................11
Principle..................................................................................................................................11
................................................................................................................................... 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................................................................ ..............18
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