ICH-Q7a（中英文對照）

FDA原料藥GMP指南 

Table of Contents

目錄

1. INTRODUCTION

1. 簡介

1.1 Objective

1.1目的

1.2 Regulatory Applicability

1.2法規的適用性

1.3 Scope

1.3范圍

2. QUALITY MANAGEMENT

2.質量管理

2.1 Principles

2.1總則 

2.2 Responsibilities of the Quality Unit(s)

2.2質量部門的責任

2.3 Responsibility for Production Activities

2.3生產作業的職責

2.4 Internal Audits (Self Inspection)

2.4內部審計（自檢）

2.5 Product Quality Review

2.5產品質量審核

3. PERSONNEL

3. 人員

3.1 Personnel Qualifications

3.人員的資質

3.2 Personnel Hygiene

3.2 人員衛生

3.3 Consultants

3.3 顧問

4. BUILDINGS AND FACILITIES

4. 建筑和設施

4.1 Design and Construction

4.1 設計和結構

4.2 Utilities

4.2 公用設施

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 衛生和保養

5. PROCESS EQUIPMENT

5. 工藝設備

5.1 Design and Construction

5.1 設計和結構

5.2 Equipment Maintenance and Cleaning

5.2 設備保養和清潔

5.3 Calibration

5.3 校驗

5.4 Computerized Systems

5.4 計算機控制系統

6. DOCUMENTATION AND RECORDS

6. 文件和記錄

6.1 Documentation System and Specifications

6.1 文件系統和質量標準

6.2 Equipment cleaning and Use Record

6.2 設備的清潔和使用記錄

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

Materials

6.3 原料、中間體、原料藥的標簽和包裝材料的記錄

6.4 Master Production Instructions (Master Production and Control Records)

6.4 生產工藝規程（主生產和控制記錄）

6.5 Batch Production Records (Batch Production and Control Records)

6.5 批生產記錄（批生產和控制記錄）

6.6 Laboratory Control Records

6.6 實驗室控制記錄

6.7 Batch Production Record Review

6.7批生產記錄審核

7. MATERIALS MANAGEMENT物料管理

7.1 General Controls

7.1 控制通則

7.2 Receipt and Quarantine

7.2接收和待驗

7.3 Sampling and Testing of Incoming Production Materials

7.3 進廠物料的取樣與測試

7.4 Storage

7.4儲存

7.5 Re-evaluation

7.5復驗

8. PRODUCTION AND IN-PROCESS CONTROLS

8. 生產和過程控制

8.1 Production Operations

8.1 生產操作

8.2 Time Limits

8.2 時限

8.3 In-process Sampling and Controls

8.3 工序取樣和控制

8.4 Blending Batches of Intermediates or APIs

8.4 中間體或原料藥的混批

8.5 Contamination Control

8.5 污染控制

9. PACKAGING AND IDENTIFICATION LABELING OF APIs AND INTERMEDIATES

9. 原料藥和中間體的包裝和貼簽

9.1 General 9.1 總則

9.2 Packaging Materials

9.2 包裝材料

9.3 Label Issuance and Control

9.3 標簽發放與控制

9.4 Packaging and Labeling Operations

9.4 包裝和貼簽操作

10. STORAGE AND DISTRIBUTION

10.儲存和分發

10.1 Warehousing Procedures

10.1 入庫程序

10.2 Distribution Procedures

10.2 分發程序

11. LABORATORY CONTROLS

11.實驗室控制

11.1 General Controls

11.1 控制通則

11.2 Testing of Intermediates and APIs

11.2 中間體和原料藥的測試

11.3 Validation of Analytical Procedures

11.3 分析方法的驗證

11.4 Certificates of Analysis

11.4 分析報告單

11.5 Stability Monitoring of APIs

11.5 原料藥的穩定性監測

11.6 Expiry and Retest Dating

11.6 有效期和復驗期

11.7 Reserve/Retention Samples

11.7 留樣

12. VALIDATION

12.驗證

12.1 Validation Policy

12.1 驗證方針

12.2 Validation Documentation

12.2 驗證文件

12.3 Qualification

12.3 確認

12.4 Approaches to Process Validation

12.4 工藝驗證的方法

12.5 Process Validation Program

12.5 工藝驗證的程序

12.6 Periodic Review of Validated Systems

12.6驗證系統的定期審核

12.7 Cleaning Validation

12.7 清洗驗證

12.8 Validation of Analytical Methods

12.8 分析方法的驗證

13. CHANGE CONTROL

13.變更的控制

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 物料與溶劑的回收

14.5 Returns

14.5 退貨

15. COMPLAINTS AND RECALLS

15.投訴與召回

16. CONTRACT MANUFACTURERS(INCLUDING LABORATORIES)

16.協議生產商（包括實驗室）

17. AGENTS, BROKERS, TRADERS, DISTRIBUTORS, REPACKERS, ANDRELABELLERS

17.代理商、經紀人、貿易商、經銷商、重新包裝者和重新貼簽者

17.1 Applicability

17.1適用性

17.2 Traceability of Distributed APIs and Intermediates

17.2已分發的原料藥和中間體的可追溯性

17.3 Quality Management

17.3質量管理

17.4 Repackaging, Relabeling, and Holding of APIs and Inthtmlermediates

17.4原料藥和中間體的重新包裝、重新貼簽和待檢

17.5 Stability

17.5穩定性

17.6 Transfer of Information

17.6 信息的傳達

17.7 Handling of Complaints and Recalls

17.7 投訴和召回的處理

17.8 Handling of Returns

17.8 退貨的處理

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

18. 用細胞繁殖/發酵生產的原料藥的特殊指南

18.1 General 18.1 總則

18.2 Cell Bank Maintenance and Record Keeping

18.2細胞庫的維護和記錄的保存

18.3 Cell Culture/Fermentation

18.3細胞繁殖/發酵 

18.4 Harvesting, Isolation and Purification

18.4收取、分離和精制

18.5 Viral Removal/Inactivation steps

18.5 病毒的去除/滅活步驟

19. APIs for Use in Clinical Trials

19. 用于臨床研究的原料藥

19.1 General

19.1 總則

19.2 Quality

19.2 質量

19.3 Equipment and Facilities

19.3 設備和設施

19.4 Control of Raw Materials

19.4 原料的控制

19.5 Production

19.5 生產

19.6 Validation

19.6 驗證

19.7 Changes

19.7 變更

19.8 Laboratory Controls

19.8 實驗室控制

19.9 Documentation

19.9 文件

20. Glossary

20. 術語