）》
（2010年修订
年修订）
药品生产质量管理规范（
《Good Manufacturing Practice (2010 revision) 》
Reviewed by ISPE
Ma Yiling, Zhang Jianye, Yang Yalan
Initial Translation from NNE Pharmaplan
目录
Table of Contents
第一章 总则 (5)
第一章
Chapter1 General Provisions (5)
第二章质量管理 (6)
Chapter 2 Quality management (6)
.第一节原 则 (6)
.Section 1 Principle (6)
.第二节 质量保证 (6)
.Section 2 Quality Assurance (6)
.第三节 质量控制 (8)
.Section 3 Quality Control (8)
第三章 机构与人员 (10)
Chapter 3 Organization and personnel (10)
.第一节 原 则 (10)
.Section 1 principle (10)
.第二节 关键人员 (10)
.Section 2 Key Personnel (10)
.第三节 培 训 (14)
.Section 3 training (14)
第四章 厂房与设施 (16)
Chapter 4 Premises and facilities (16)
.第一节 原 则 (16)
.Section 1 principle (16)
.
第二节 生产区 (17)
.Section 2 Production Area (17)
.第三节 仓储区 (20)
.Section 3 Storage Areas (20)
.第四节 质量控制区 (21)
.Section 4 Quality Control Areas (21)
.第五节 辅助区 (21)
.Section 5 Ancillary Areas (21)
第五章 设 备 (22)
Chapter 5 Equipment (22)
.第一节 原 则 (22)
.
Section 1 principle (22)
.第二节 设计和安装 (22)
.Section 2 Design and Installation (22)
.第三节 维护和维修 (23)
.Section 3 Maintenance and Repair (23)
.第四节 使用和清洁 (23)
.Section 4 Usage and Clean (23)
.第五节 校 准 (24)
.Section 5 Calibration (24)
.第六节 制药用水 (25)
.Section 6 Water for Pharmaceutical Process (25)
第六章物料与产品 (26)
Chapter 6 Material and products (26)
.第一节原 则 (26)
.Section 1 Principle (26)
.第二节 原辅料 (27)
.Section 2 Raw materials and Excipients (27)
.
第三节中间产品和待包装产品 (28)
.Section 3 Intermediate and Bulk products (28)
.第四节 包装材料 (29)
.Section 4 Packaging material (29)
.第五节成 品 (30)
.Section 5 Finished products (30)
.第六节特殊管理的物料和产品 (30)
.Section 6 Particular management for materials and products (30)
.第七节其 他 (30)
.Section 7 others (30)
第七章确认与验证 (32)
Chapter 7 Qualification and validation (32)
第八章文件管理 (34)
Chapter 8 Documentation (34)
.第一节原 则 (34)
.Section 1 Principle (34)
.第二节质量标准 (36)
.Section 2 Specification (36)
.第三节工艺规程 (37)
.Section 3 Process procedures (37)
.第四节批生产记录 (39)
.Section 4 Batch Production Records (39)
.
第五节批包装记录 (40)
.Section 5 Batch Packaging Records (40)
.第六节操作规程和记录 (41)
.Section 6 Operation Procedures and Records (41)
第九章 生产管理 (42)
Chapter 9 Production Section (42)
.第一节 原 则 (42)
.Section 1 Principle (42)
美食食谱英文翻译版.第二节防止生产过程中的污染和交叉污染 (44)
.Section 2 Prevention of Contamination and cross contamination (44)
.第三节生产操作 (45)
.Section 3 Production Operations (45)
.第四节包装操作 (45)
.Section 4 Packaging Operations (45)
第十章质量控制与质量保证 (47)
Chapter 10Quality Control and Quality Assurance (47)
.第一节质量控制实验室管理 (47)
.Section 1 Good Quality Control Laboratory Practice (47)
.第二节物料和产品放行 (55)
.
Section 2 Release for Materials and Products (55)
.第三节持续稳定性考察 (56)
.Section 3 On-going stability programme (56)
.第四节变更控制 (58)
.Section 4 Change control (58)
.第五节偏差处理 (59)
.Section 5 Deviation Treatment (59)
.第六节纠正措施和预防措施 (60)
.Section 6 Corrective action and preventive action (CAPA) (60)
.第七节供应商的评估和批准 (61)
.Section 7 Audit and approal of suppliers (61)
.
第八节产品质量回顾分析 (63)
.Section 8 Product Quality Review (63)
.第九节 投诉与不良反应报告 (65)
.Section 9 Complaints and Adverse Reactions Report (65)
第十一章 委托生产与委托检验 (66)
Chapter 11 Contract manufacture and analysis (66)
.第一节原 则 (66)
.Section 1 Principle (66)
.第二节委托方 (66)
.Section 2 The Contract Giver (66)
.第三节受托方 (66)
.
Section 3 The Contract Acceptor (66)
.第四节合 同 (67)
.Section 4 The Contract (67)
第十二章 产品发运与召回 (68)
Chapter 12 Product distribution and recall (68)
.第一节原 则 (68)
.Section 1 Principle (68)
.第二节发 运 (68)
.Section 2 Distribution (68)
.第三节召 回 (68)
.Section 3 Recalls (68)
第十三章 自 检 (69)
Chapter 13Self inspection (69)
.第一节 原 则 (69)
.Section 1Principle (69)
.第二节 自 检 (69)
.Section 2Self inspection (69)
第十四章 附 则 (70)
Chapter 14 Glossary (70)
Note:
Highlight (Yellow) is the differences between EU GMP and SFDA GMP (new version). The first difference is that Chinese GMP combines all the requirements for both API and medicinal products, while EU GMP divides them to two parts.
No highlight: is the similarity between the two guidelines.
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