原料药GMP指南中英文对照

Q7a（中英文对照）

FDA原料药GMP指南

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 文件系统和质量标准

6.1 Documentation System and

Specifications

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, 6.3 原料、中间体、原料药的标签和包装材

Intermediates, API Labeling and Packaging

料的记录

Materials

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

Production and Control Records)

6.5 Batch Production Records (Batch

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

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 进厂物料的取样与测试

7.3 Sampling and Testing of Incoming

Production Materials

7.4 Storage 7.4储存

7.5 Re-evaluation 7.5复验

8. PRODUCTION AND IN-PROCESS

8. 生产和过程控制

CONTROLS

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

8.4 中间体或原料药的混批

APIs

8.5 Contamination Control 8.5 污染控制

9. 原料药和中间体的包装和贴签

9. PACKAGING AND IDENTIFICATION

LABELING OF APIs AND

INTERMEDIATES

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