欧盟GMP中英文对照
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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)
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................................................................ .. (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)