DIRECTION OF GMP (GOOD MANUFACTURING PRACTICE )OF RAW MATERIALS BY FDA

Table of Contents 目录

1. INTRODUCTION 1.1 Objective 目的

1.2 Regulatory Applicability法规的适用性 1.3 Scope 范围

2. QUALITY MANAGEMENT .质量管理 2.1 Principles 总则

2.2 Responsibilities of the Quality Unit(s) 质量部门的责任 2.3 Responsibility for Production Activities 生产作业的职责 2.4 Internal Audits (Self Inspection) 内部审计（自检） 2.5 Product Quality Review 产品质量审核

3. PERSONNEL 人员

3.1 Personnel Qualifications 人员的资质 3.2 Personnel Hygiene 人员卫生 3.3 Consultants 顾问

4. BUILDINGS AND FACILITIES 建筑和设施 4.1 Design and Construction 设计和结构 4.2 Utilities 公用设施 4.3 Water 水

4.4 Containment 限制 4.5 Lighting 照明

4.6 Sewage and Refuse 排污和垃圾

4.7 Sanitation and Maintenance 卫生和保养

5. PROCESS EQUIPMENT 工艺设备

5.1 Design and Construction 设计和结构

5.2 Equipment Maintenance and Cleaning 设备保养和清洁 5.3 Calibration. 校验

5.4 Computerized Systems 计算机控制系统

6. DOCUMENTATION AND RECORDS 文件和记录

6.1 Documentation System and Specifications 文件系统和质量标准 6.2 Equipment cleaning and Use Record 设备的清洁和使用记录

6.3 Records of Raw Materials, Intermediates, API Labeling and Packaging Materials

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原料、中间体、原料药的标签和包装材料的记录

6.4 Master Production Instructions (Master Production and Control Records) 生产工艺规程（主生产和控制记录）

6.5 Batch Production Records (Batch Production and Control Records) 批生产记录（批生产和控制记录）

6.6 Laboratory Control Records 实验室控制记录

6.7 Batch Production Record Review 批生产记录审核

7. MATERIALS MANAGEMENT 物料管理 7.1 General Controls 控制通则

7.2 Receipt and Quarantine 接收和待验

7.3 Sampling and Testing of Incoming Production Materials 进厂物料的取样与测试 7.4 Storage 储存

7.5 Re-evaluation 复验

8. PRODUCTION AND IN-PROCESS CONTROLS 生产和过程控制 8.1 Production Operations 生产操作 8.2 Time Limits 时限

8.3 In-process Sampling and Controls 工序取样和控制

8.4 Blending Batches of Intermediates or APIs 中间体或原料药的混批 8.5 Contamination Control 污染控制

9. PACKAGING AND IDENTIFICATION LABELING OF APIs AND INTERMEDIATES 原料药和中间体的包装和贴签 9.1 General 总则

9.2 Packaging Materials 包装材料

9.3 Label Issuance and Control 标签发放与控制

9.4 Packaging and Labeling Operations 包装和贴签操作

10. STORAGE AND DISTRIBUTION.储存和分发 10.1 Warehousing Procedures 入库程序 10.2 Distribution Procedures 分发程序

11. LABORATORY CONTROLS 实验室控制 11.1 General Controls 控制通则

11.2 Testing of Intermediates and APIs 中间体和原料药的测试 11.3 Validation of Analytical Procedures 分析方法的验证 11.4 Certificates of Analysis分析报告单

11.5 Stability Monitoring of APIs 原料药的稳定性监测 11.6 Expiry and Retest Dating 有效期和复验期 11.7 Reserve/Retention Samples 留样

12. VALIDATION .验证

12.1 Validation Policy 验证方针

12.2 Validation Documentation 验证文件 12.3 Qualification 确认

12.4 Approaches to Process Validation 工艺验证的方法

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12.5 Process Validation Program 工艺验证的程序

12.6 Periodic Review of Validated Systems 验证系统的定期审核 12.7 Cleaning Validation 清洗验证

12.8 Validation of Analytical Methods 分析方法的验证

13. CHANGE CONTROL 变更的控制

14. REJECTION AND RE-USE OF MATERIALS.拒收和物料的再利用 14.1 Rejection 拒收 14.2 Reprocessing 返工 14.3 Reworking 重新加工

14.4 Recovery of Materials and Solvents 物料与溶剂的回收 14.5 Returns 退货

15. COMPLAINTS AND RECALLS 投诉与召回

16. CONTRACT MANUFACTURERS (INCLUDING LABORATORIES) 协议生产商（包括实验室）

17. AGENTS, BROKERS, TRADERS, DISTRIBUTORS, REPACKERS, AND RELABELLERS 代理商、经纪人、贸易商、经销商、重新包装者和重新贴签者 17.1 Applicability 适用性

17.2 Traceability of Distributed APIs and Intermediates已分发的原料药和中间体的可追溯性 17.3 Quality Management 质量管理

17.4 Repackaging, Relabeling, and Holding of APIs and Intermediates 原料药和中间体的重新包装、重新贴签和待检 17.5 Stability 稳定性

17.6 Transfer of Information 信息的传达

17.7 Handling of Complaints and Recalls 投诉和召回的处理 17.8 Handling of Returns 退货的处理

18. Specific Guidance for APIs Manufactured by Cell Culture/Fermentation 用细胞繁殖/发酵生产的原料药的特殊指南 18.1 General 总则

18.2 Cell Bank Maintenance and Record Keeping 细胞库的维护和记录的保存 18.3 Cell Culture/Fermentation 细胞繁殖/发酵

18.4 Harvesting, Isolation and Purification 收取、分离和精制 18.5 Viral Removal/Inactivation steps 病毒的去除/灭活步骤

19. APIs for Use in Clinical Trials 用于临床研究的原料药 19.1 General 总则 19.2 Quality 质量

19.3 Equipment and Facilities设备和设施 19.4 Control of Raw Materials 原料的控制 19.5 Production 生产 19.6 Validation 验证 19.7 Changes 变更

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