18.2 细胞库的维护和记录的保存 18.3 细胞繁殖/发酵 18.4 收取、分离和精制 18.5 病毒的去除/灭活步骤
19. APIs for Use in Clinical Trials 19.1 General 19.2 Quality 19.3 Equipment and Facilities 19.4 Control of Raw Materials 19.5 Production 19.6 Validation 19.7 Changes 19.8 Laboratory Controls 19.9 Documentation
Production
7. 物料管理 7.1 控制通则 7.2 接收和待验 7.3 进厂物料的取样与测试
7.4 储存 7.5 复验
8. PRODUCTION AND IN-PROCESS CONTROLS 8.1 Production Operations 8.2 Time Limits 8.3 In-process Sampling and Controls 8.4 Blending Batches of Intermediates or APIs 8.5 Contamination Control
Q7a（中英文对照）
FDA 原料药 GMP 指南
Table of Contents
1. INTRODUCTION 1.1 Objective 1.2 Regulatory Applicability 1.3 Scope
2. QUALITY MANAGEMENT 2.1 Principles 2.2 Responsibilities of the Quality Unit(s) 2.3 Responsibility for Production Activities 2.4 Internal Audits (Self Inspection) 2.5 Product Quality Review
3. PERSONNEL 3.1 Personnel Qualifications 3.2 Personnel Hygiene 3.3 Consultants
4. BUILDINGS AND FACILITIES 4.1 Design and Construction 4.2 Utilities 4.3 Water 4.4 Containment 4.5 Lighting 4.6 Sewage and Refuse 4.7 Sanitation and Maintenance
5. PROCESS EQUIPMENT 5.1 Design and Construction 5.2 Equipment Maintenance and Cleaning 5.3 Calibration
目录
1. 简介 1.1 目的 1.2 法规的适用性 1.3 范围
2.质量管理 2.1 总则 2.2 质量部门的责任 2.3 生产作业的职责 2.4 内部审计（自检） 2.5 产品质量审核
17. AGENTS, BROKERS, TRADERS, DISTRIBUTORS, REPACKERS, AND RELABELLERS 17.1 Applicability 17.2 Traceability of Distributed APIs and Intermediates 17.3 Quality Management 17.4 Repackaging, Relabeling, and Holding of APIs and Intermediates 17.5 Stability 17.6 Transfer of Information 17.7 Handling of Complaints and Recalls 17.8 Handling of Returns
19. 用于临床研究的原料药 19.1 总则 19.2 质量 19.3 设备和设施 19.4 原料的控制 19.5 生产 19.6 验证 19.7 变更 19.8 实验室控制 19.9 文件
20. Glossary
20. 术语
4
EC_Q7a
Q7a GMP Guidance for APIs Q7a 原料药的 GMP 指南
12.验证 12.1 验证方针 12.2 验证文件 12.3 确认 12.4 工艺验证的方法 12.5 工艺验证的程序 12.6 验证系统的定期审核 12.7 清洗验证 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 14.1 Rejection 14.2 Reprocessing 14.3 Reworking 14.4 Recovery of Materials and Solvents 14.5 Returns
2
EC_Q7a
11.4 Certificates of Analysis 11.5 Stability Monitoring of APIs 11.6 Expiry and Retest Dating 11.7 Reserve/Retention Samples
11.4 分析报告单 11.5 原料药的稳定性监测 11.6 有效期和复验期 11.7 留样
11. LABORATORY CONTROLS 11.1 General Controls 11.2 Testing of Intermediates and APIs 11.3 Validation of Analytical Procedures
11.实验室控制 11.1 控制通则 11.2 中间体和原料药的测试 11.3 分析方法的验证
3. 人员 3.人员的资质 3.2 人员卫生 3.3 顾问
4. 建筑和设施 4.1 设计和结构 4.2 公用设施 4.3 水 4.4 限制 4.5 照明 4.6 排污和垃圾 4.7 卫生和保养
5. 工艺设备 5.1 设计和结构 5.2 设备保养和清洁 5.3 校验
EC_Q7a
5.4 Computerized Systems
Culture/Fermentation
指南
18.1 General
18.1 总则
3
EC_Q7a
18.2 Cell Bank Maintenance and Record Keeping 18.3 Cell Culture/Fermentation 18.4 Harvesting, Isolation and Purification 18.5 Viral Removal/Inactivation steps
5.4 计算机控制系统
6. DOCUMENTATION AND RECORDS 6.1 Documentation System and Specifications 6.2 Equipment cleaning and Use Record 6.3 Records of Raw Materials, Intermediates, API Labeling and Packaging Materials 6.4 Master Production Instructions (Master Production and Control Records) 6.5 Batch Production Records (Batch Production and Control Records) 6.6 Laboratory Control Records 6.7 Batch Production Record Review
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 适用性 17.2 已分发的原料药和中间体的可追溯性 17.3 质量管理 17.4 原料药和中间体的重新包装、重新贴签 和待检 17.5 稳定性 17.6 信息的传达 17.7 投诉和召回的处理 17.8 退货的处理
18. Specific Guidance for APIs Manufactured by Cell 18. 用细胞繁殖/发酵生产的原料药的特殊
12. VALIDATION 12.1 Validation Policy 12.2 Validation Documentation 12.3 Qualification 12.4 Approaches to Process Validation 12.5 Process Validation Program 12.6 Periodic Review of Validated Systems 12.7 Cleaning Validation 12.8 Validation of Analytical Methods
6. 文件和记录 6.1 文件系统和质量标准 6.2 设备的清洁和使用记录 6.3 原料、中间体、原料药的标签和包装材 料的记录 6.4 生产工艺规程（主生产和控制记录）
6.5 批生产记录（批生产和控制记录）
6.6 实验室控制记录 6.7 批生产记录审核
7. MATERIALS MANAGEMENT 7.1 General Controls 7.2 Receipt and Quarantine 7.3 Sampling and Testing of Incoming Materials 7.4 Storage 7.5 Re-evaluation
1. INTRODUCTION 1.1 Objective This document is intended to provide guidanceng practice (GMP) for the manufacturing of active pharmaceutical ingredients (APIs) under an appropriate system for managing quality. It is also intended to help ensure that APIs meet the quality and purity characteristics that they purport, or are represented, to possess.