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1、DIRECTION OF GMP (GOOD MANUFACTURING PRACTICE )OF RAW MATERIALS BY FDATable of Contents目录1. INTRODUCTION1.1 Objective目的1.2 Regulatory Applicability法规的适用性1.3 Scope范围2. QUALITY MANAGEMENT.质量管理2.1 Principles总则2.2 Responsibilities of the Quality Unit(s)质量部门的责任2.3 Responsibility for Production Activities
2、生产作业的职责2.4 Internal Audits (Self Inspection)内部审计（自检）2.5 Product Quality Review产品质量审核3. PERSONNEL人员3.1 Personnel Qualifications人员的资质3.2 Personnel Hygiene人员卫生3.3 Consultants顾问4. BUILDINGS AND FACILITIES建筑和设施4.1 Design and Construction设计和结构4.2 Utilities公用设施4.3 Water水4.4 Containment限制4.5 Lighting照明4.6 S
3、ewage and Refuse排污和垃圾4.7 Sanitation and Maintenance卫生和保养5. PROCESS EQUIPMENT工艺设备5.1 Design and Construction设计和结构5.2 Equipment Maintenance and Cleaning设备保养和清洁5.3 Calibration.校验5.4 Computerized Systems计算机控制系统6. DOCUMENTATION AND RECORDS文件和记录6.1 Documentation System and Specifications文件系统和质量标准6.2 Equip
4、ment cleaning and Use Record设备的清洁和使用记录6.3 Records of Raw Materials, Intermediates, API Labeling and Packaging Materials原料、中间体、原料药的标签和包装材料的记录6.4 Master Production Instructions (Master Production and Control Records)生产工艺规程（主生产和控制记录）6.5 Batch Production Records (Batch Production and Control Records)批生产
5、记录（批生产和控制记录）6.6 Laboratory Control Records实验室控制记录6.7 Batch Production Record Review批生产记录审核7. MATERIALS MANAGEMENT物料管理7.1 General Controls控制通则7.2 Receipt and Quarantine接收和待验7.3 Sampling and Testing of Incoming Production Materials进厂物料的取样与测试7.4 Storage储存7.5 Re-evaluation复验8. PRODUCTION AND IN-PROCESS
6、CONTROLS生产和过程控制8.1 Production Operations生产操作8.2 Time Limits时限8.3 In-process Sampling and Controls工序取样和控制8.4 Blending Batches of Intermediates or APIs中间体或原料药的混批8.5 Contamination Control污染控制9. PACKAGING AND IDENTIFICATION LABELING OF APIs AND INTERMEDIATES原料药和中间体的包装和贴签9.1 General总则9.2 Packaging Materi
7、als包装材料9.3 Label Issuance and Control标签发放与控制9.4 Packaging and Labeling Operations包装和贴签操作10. STORAGE AND DISTRIBUTION.储存和分发10.1 Warehousing Procedures入库程序10.2 Distribution Procedures分发程序11. LABORATORY CONTROLS实验室控制11.1 General Controls控制通则11.2 Testing of Intermediates and APIs中间体和原料药的测试11.3 Validatio
8、n of Analytical Procedures分析方法的验证11.4 Certificates of Analysis分析报告单11.5 Stability Monitoring of APIs原料药的稳定性监测11.6 Expiry and Retest Dating有效期和复验期11.7 Reserve/Retention Samples留样12. VALIDATION.验证12.1 Validation Policy验证方针12.2 Validation Documentation验证文件12.3 Qualification确认12.4 Approaches to Process
9、Validation工艺验证的方法12.5 Process Validation Program工艺验证的程序12.6 Periodic Review of Validated Systems验证系统的定期审核12.7 Cleaning Validation清洗验证12.8 Validation of Analytical Methods分析方法的验证13. CHANGE CONTROL变更的控制14. REJECTION AND RE-USE OF MATERIALS.拒收和物料的再利用14.1 Rejection拒收14.2 Reprocessing返工14.3 Reworking重新加工
10、14.4 Recovery of Materials and Solvents物料与溶剂的回收14.5 Returns退货15. COMPLAINTS AND RECALLS投诉与召回16. CONTRACT MANUFACTURERS (INCLUDING LABORATORIES)协议生产商（包括实验室）17. AGENTS, BROKERS, TRADERS, DISTRIBUTORS, REPACKERS, AND RELABELLERS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 Applicability适用性17.2 Traceability of Distri
11、buted APIs and Intermediates已分发的原料药和中间体的可追溯性17.3 Quality Management质量管理17.4 Repackaging, Relabeling, and Holding of APIs and Intermediates原料药和中间体的重新包装、重新贴签和待检17.5 Stability稳定性17.6 Transfer of Information信息的传达17.7 Handling of Complaints and Recalls投诉和召回的处理17.8 Handling of Returns退货的处理18. Specific Gui
12、dance for APIs Manufactured by Cell Culture/Fermentation用细胞繁殖/发酵生产的原料药的特殊指南18.1 General总则18.2 Cell Bank Maintenance and Record Keeping细胞库的维护和记录的保存18.3 Cell Culture/Fermentation细胞繁殖/发酵18.4 Harvesting, Isolation and Purification收取、分离和精制18.5 Viral Removal/Inactivation steps病毒的去除/灭活步骤19. APIs for Use in
13、 Clinical Trials用于临床研究的原料药19.1 General总则19.2 Quality质量19.3 Equipment and Facilities设备和设施19.4 Control of Raw Materials原料的控制19.5 Production生产19.6 Validation验证19.7 Changes变更19.8 Laboratory Controls实验室控制19.9 Documentation文件20. Glossary术语1. INTRODUCTION1.简介1.1 Objective1.1目的This document is intended to p
14、rovide 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.本文件旨在为在合适的质量管理体系下
