ICH-Q7（中英文对照）

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

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

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

7. MATERIALS MANAGEMENT 7.1 General Controls

7.2 Receipt and Quarantine

7.3 Sampling and Testing of Incoming Production Materials 7.4 Storage

7.5 Re-evaluation

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

9. PACKAGING AND IDENTIFICATION LABELING OF APIs AND INTERMEDIATES 9.1 General

9.2 Packaging Materials

9.3 Label Issuance and Control

9.4 Packaging and Labeling Operations

10. STORAGE AND DISTRIBUTION 10.1 Warehousing Procedures 10.2 Distribution Procedures

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5.4 计算机控制系统

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. 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. 生产和过程控制 8.1 生产操作 8.2 时限

8.3 工序取样和控制

8.4 中间体或原料药的混批 8.5 污染控制

9. 原料药和中间体的包装和贴签

9.1 总则 9.2 包装材料

9.3 标签发放与控制 9.4 包装和贴签操作

10.储存和分发 10.1 入库程序 10.2 分发程序

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11. LABORATORY CONTROLS 11.1 General Controls

11.2 Testing of Intermediates and APIs 11.3 Validation of Analytical Procedures 11.4 Certificates of Analysis

11.5 Stability Monitoring of APIs 11.6 Expiry and Retest Dating 11.7 Reserve/Retention Samples

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

13. CHANGE CONTROL

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

15. COMPLAINTS AND RECALLS

16. CONTRACT MANUFACTURERS (INCLUDING LABORATORIES)

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

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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 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

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.变更的控制

14.拒收和物料的再利用 14.1 拒收 14.2 返工 14.3 重新加工

14.4 物料与溶剂的回收 14.5 退货

15.投诉与召回

16.协议生产商（包括实验室）

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

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17.5 Stability

17.6 Transfer of Information

17.7 Handling of Complaints and Recalls 17.8 Handling of Returns 18. Specific Guidance for APIs Manufactured by Cell Culture/Fermentation 18.1 General

18.2 Cell Bank Maintenance and Record 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. 用细胞繁殖/发酵生产的原料药的特殊指南

18.1 总则

18.2细胞库的维护和记录的保存 Keeping

18.3 Cell Culture/Fermentation

18.4 Harvesting, Isolation and Purification 18.5 Viral Removal/Inactivation steps

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

20. Glossary

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. 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. 术语

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EC_Q7a

Q7a GMP Guidance for APIs

Q7a原料药的GMP指南

1. INTRODUCTION 1.1 Objective

This document is intended to provide guidance regarding good manufacturing 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.

In this guidance, the term manufacturing is defined to include all operations of receipt of materials, production, packaging, repackaging, labeling, relabeling, quality control, release, storage and distribution of APIs and the related controls. In this guidance, the term should identifies recommendations that, when followed, will ensure compliance with CGMPs. An alternative approach may be used if such approach satisfies the requirements of the applicable statues. For the purposes of this guidance, the terms current good manufacturing practices and good manufacturing practices are equivalent.

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1. 简介 1.1目的

本文件旨在为在合适的质量管理体系下制造活性药用成分（以下称原料药）提供有关优良药品生产管理规范（GMP）提供指南。它也着眼于帮助确保原料药符合其旨在达到或表明拥有的质量与纯度要求。

本指南中所指的“制造”包括物料接收、生产、包装、重新包装、贴签、重新贴签、质量控制、放行、原料药的储存和分发及其相关控制的所有操作。本指南中，“应当”一词表示希望采用的建议，除非证明其不适用或者可用一种已证明有同等或更高质量保证水平的供选物来替代。本指南中的“现行优良生产管理规范（cGMP）”和“优良生产管理规范（GMP）”是等同的。

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