Table of Contents

目录

1. INTRODUCTION

1. 简介

1.1 Objective

1.1目的

1.2 Regulatory Applicability

1.2法规的适用性

1.3 Scope

1.3范围

2. QUALITY MANAGEMENT

2.质量管理

2.1 Principles

2.1总则

2.2 Responsibilities of the Quality Unit(s)

2.2质量部门的责任

2.3 Responsibility for Production Activities

2.3生产作业的职责

2.4 Internal Audits (Self Inspection)

2.4内部审计（自检）

2.5 Product Quality Review

2.5产品质量审核

3. PERSONNEL

3. 人员

3.1 Personnel Qualifications

3.人员的资质

3.2 Personnel Hygiene

3.2 人员卫生

3.3 Consultants

3.3 顾问

4. BUILDINGS AND FACILITIES

4. 建筑和设施

4.1 Design and Construction

4.1 设计和结构

4.2 Utilities

4.2 公用设施

4.3 Water

4.3 水

4.4 Containment

4.4 限制

4.5 Lighting

4.5 照明

4.6 Sewage and Refuse

4.6 排污和垃圾

4.7 Sanitation and Maintenance

4.7 卫生和保养

5. PROCESS EQUIPMENT

5. 工艺设备

5.1 Design and Construction

5.1 设计和结构

5.2 Equipment Maintenance and Cleaning

5.2 设备保养和清洁

5.3 Calibration

5.3 校验

5.4 Computerized Systems

5.4 计算机控制系统

6. DOCUMENTATION AND RECORDS

6. 文件和记录

6.1 Documentation System and Specifications

6.1 文件系统和质量标准

6.2 Equipment cleaning and Use Record

6.2 设备的清洁和使用记录

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

6.3 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)

6.4 生产工艺规程（主生产和控制记录）

6.5 Batch Production Records (Batch Production and Control Records)

6.5 批生产记录（批生产和控制记录）

6.6 Laboratory Control Records

6.6 实验室控制记录

6.7 Batch Production Record Review

6.7批生产记录审核

7. MATERIALS MANAGEMENT

7. 物料管理

7.1 General Controls

7.1 控制通则

7.2 Receipt and Quarantine

7.2接收和待验

7.3 Sampling and Testing of Incoming Production Materials

7.3 进厂物料的取样与测试

7.4 Storage

7.4储存

7.5 Re-evaluation

7.5复验

8. PRODUCTION AND IN-PROCESS CONTROLS

8. 生产和过程控制

8.1 Production Operations

8.1 生产操作

8.2 Time Limits

8.2 时限

8.3 In-process Sampling and Controls

8.3 工序取样和控制

8.4 Blending Batches of Intermediates or APIs

8.4 中间体或原料药的混批

8.5 Contamination Control

8.5 污染控制

9. PACKAGING AND IDENTIFICATION LABELING OF APIs AND INTERMEDIATES

9. 原料药和中间体的包装和贴签

9.1 General

9.1 总则

9.2 Packaging Materials

9.2 包装材料

9.3 Label Issuance and Control

9.3 标签发放与控制

9.4 Packaging and Labeling Operations

9.4 包装和贴签操作

10. STORAGE AND DISTRIBUTION

10.储存和分发

10.1 Warehousing Procedures

10.1 入库程序

10.2 Distribution Procedures

10.2 分发程序

11. LABORATORY CONTROLS

11.实验室控制

11.1 General Controls

11.1 控制通则

11.2 Testing of Intermediates and APIs

11.2 中间体和原料药的测试

11.3 Validation of Analytical Procedures

11.3 分析方法的验证

11.4 Certificates of Analysis

11.4 分析报告单

11.5 Stability Monitoring of APIs

11.5 原料药的稳定性监测

11.6 Expiry and Retest Dating

11.6 有效期和复验期

11.7 Reserve/Retention Samples

11.7 留样

12. VALIDATION

12.验证

12.1 Validation Policy

12.1 验证方针

12.2 Validation Documentation

12.2 验证文件

12.3 Qualification

12.3 确认

12.4 Approaches to Process Validation

12.4 工艺验证的方法

12.5 Process Validation Program

12.5 工艺验证的程序

12.6 Periodic Review of Validated Systems

12.6验证系统的定期审核

12.7 Cleaning Validation

12.7 清洗验证

12.8 Validation of Analytical Methods

12.8 分析方法的验证

13. CHANGE CONTROL

13.变更的控制

14. REJECTION AND RE-USE OF MATERIALS

14.拒收和物料的再利用

14.1 Rejection

14.1 拒收

14.2 Reprocessing

14.2 返工

14.3 Reworking

14.3 重新加工

14.4 Recovery of Materials and Solvents

14.4 物料与溶剂的回收

14.5 Returns

14.5 退货

15. COMPLAINTS AND RECALLS

15.投诉与召回

16. CONTRACT MANUFACTURERS (INCLUDING LABORATORIES)

16.协议生产商（包括实验室）

17. AGENTS, BROKERS, TRADERS, DISTRIBUTORS, REPACKERS, AND RELABELLERS

17.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

17.1适用性

17.2 Traceability of Distributed APIs and Intermediates

17.2已分发的原料药和中间体的可追溯性

17.3 Quality Management

17.3质量管理

17.4 Repackaging, Relabeling, and Holding of APIs and Intermediates

17.4原料药和中间体的重新包装、重新贴签和待检

17.5 Stability

17.5稳定性

17.6 Transfer of Information

17.6 信息的传达

17.7 Handling of Complaints and Recalls

17.7 投诉和召回的处理

17.8 Handling of Returns

17.8 退货的处理

18. Specific Guidance for APIs Manufactured by Cell Culture/Fermentation

18. 用细胞繁殖/发酵生产的原料药的特殊指南

18.1 General

18.1 总则

18.2 Cell Bank Maintenance and Record Keeping

18.2细胞库的维护和记录的保存

18.3 Cell Culture/Fermentation

18.3细胞繁殖/发酵

18.4 Harvesting, Isolation and Purification

18.4收取、分离和精制

18.5 Viral Removal/Inactivation steps

18.5 病毒的去除/灭活步骤

19. APIs for Use in Clinical Trials

19. 用于临床研究的原料药

19.1 General

19.1 总则

19.2 Quality

19.2 质量

19.3 Equipment and Facilities

19.3 设备和设施

19.4 Control of Raw Materials

19.4 原料的控制

19.5 Production

19.5 生产

19.6 Validation

19.6 验证

19.7 Changes

19.7 变更

19.8 Laboratory Controls

19.8 实验室控制

19.9 Documentation

19.9 文件

20. Glossary

20. 术语