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
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)
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
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）
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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
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
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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
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
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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 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 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
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
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 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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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.
The guidance as a whole does not cover safety aspects for the personnel engaged in manufacturing, nor aspects related to protecting the environment. These controls are inherent responsibilities of the manufacturer and are governed by national laws.
This guidance is not intended to define registration and/or filing requirements or modify pharmacopoeial requirements. This guidance does not affect the ability of the responsible regulatory agency to establish specific registration/filing requirements regarding APIs within the context of marketing/manufacturing authorizations or drug applications. All commitments in registration/filing documents should be met.
1.2 Regulatory Applicability
Within the world community, materials may vary
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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。
本指南在总体上未涉及生产人员的安全问题，亦不包括环保方面的内容。这方面的管理是生产者固有的责任，也是国家法律规定的。
本指南未规定注册/归档的要求、或修改药典的要求。本指南不影响负责药政审理部门在原料药上市/制造授权或药品申请方面建立特定注册/归档要求的能力。注册/归档的所有承诺必须做到。
1.2法规的适用性
在世界范围内对原料药的法定定义是各不相同