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1、Q7a（中英文对照）FDA原料药GMP指南Table of Contents目录1. INTRODUCTION1. 简介1.1 Objective1.1目的1.2 Regulatory Applicability1.2法规的适用性1.3 Scope1.3范围2. QUALITY MANAGEMENT2.质量管理2.1 Principles2.1总则2.2 Responsibilities of the Quality Unit(s)2.2质量部门的责任2.3 Responsibility for Production Activities2.3生产作业的职责2.4 Internal Audit
2、s (Self Inspection)2.4内部审计（自检）2.5 Product Quality Review2.5产品质量审核3. PERSONNEL3. 人员3.1 Personnel Qualifications3.人员的资质3.2 Personnel Hygiene3.2 人员卫生3.3 Consultants3.3 顾问4. BUILDINGS AND FACILITIES4. 建筑和设施4.1 Design and Construction4.1 设计和结构4.2 Utilities4.2 公用设施4.3 Water4.3 水4.4 Containment4.4 限制4.5 Li
3、ghting4.5 照明4.6 Sewage and Refuse4.6 排污和垃圾4.7 Sanitation and Maintenance4.7 卫生和保养5. PROCESS EQUIPMENT5. 工艺设备5.1 Design and Construction5.1 设计和结构5.2 Equipment Maintenance and Cleaning5.2 设备保养和清洁5.3 Calibration5.3 校验5.4 Computerized Systems5.4 计算机控制系统6. DOCUMENTATION AND RECORDS6. 文件和记录6.1 Documentati
4、on System and Specifications6.1 文件系统和质量标准6.2 Equipment cleaning and Use Record6.2 设备的清洁和使用记录6.3 Records of Raw Materials, Intermediates, API Labeling and Packaging Materials6.3 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)6.4 生产工艺规程（主生产和控制记录）6.5 Batc
5、h Production Records (Batch Production and Control Records)6.5 批生产记录（批生产和控制记录）6.6 Laboratory Control Records6.6 实验室控制记录6.7 Batch Production Record Review6.7批生产记录审核7. MATERIALS MANAGEMENT7. 物料管理7.1 General Controls7.1 控制通则7.2 Receipt and Quarantine7.2接收和待验7.3 Sampling and Testing of Incoming Producti
6、on Materials7.3 进厂物料的取样与测试 7.4 Storage7.4储存7.5 Re-evaluation7.5复验8. PRODUCTION AND IN-PROCESS CONTROLS8. 生产和过程控制8.1 Production Operations8.1 生产操作8.2 Time Limits8.2 时限8.3 In-process Sampling and Controls8.3 工序取样和控制8.4 Blending Batches of Intermediates or APIs8.4 中间体或原料药的混批8.5 Contamination Control8.5
7、 污染控制9. PACKAGING AND IDENTIFICATION LABELING OF APIs AND INTERMEDIATES9. 原料药和中间体的包装和贴签9.1 General9.1 总则9.2 Packaging Materials9.2 包装材料9.3 Label Issuance and Control9.3 标签发放与控制9.4 Packaging and Labeling Operations9.4 包装和贴签操作10. STORAGE AND DISTRIBUTION10.储存和分发10.1 Warehousing Procedures10.1 入库程序10.2
8、 Distribution Procedures10.2 分发程序11. LABORATORY CONTROLS11.实验室控制11.1 General Controls11.1 控制通则11.2 Testing of Intermediates and APIs11.2 中间体和原料药的测试11.3 Validation of Analytical Procedures11.3 分析方法的验证11.4 Certificates of Analysis11.4 分析报告单11.5 Stability Monitoring of APIs11.5 原料药的稳定性监测11.6 Expiry and
9、 Retest Dating11.6 有效期和复验期11.7 Reserve/Retention Samples11.7 留样12. VALIDATION12.验证12.1 Validation Policy12.1 验证方针12.2 Validation Documentation12.2 验证文件12.3 Qualification12.3 确认12.4 Approaches to Process Validation12.4 工艺验证的方法12.5 Process Validation Program12.5 工艺验证的程序12.6 Periodic Review of Validate
10、d Systems12.6验证系统的定期审核12.7 Cleaning Validation12.7 清洗验证12.8 Validation of Analytical Methods12.8 分析方法的验证13. CHANGE CONTROL13.变更的控制14. REJECTION AND RE-USE OF MATERIALS14.拒收和物料的再利用14.1 Rejection14.1 拒收14.2 Reprocessing14.2 返工14.3 Reworking14.3 重新加工14.4 Recovery of Materials and Solvents14.4 物料与溶剂的回收1
11、4.5 Returns14.5 退货15. COMPLAINTS AND RECALLS15.投诉与召回16. CONTRACT MANUFACTURERS (INCLUDING LABORATORIES)16.协议生产商（包括实验室）17. AGENTS, BROKERS, TRADERS, DISTRIBUTORS, REPACKERS, AND RELABELLERS17.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 Applicability17.1适用性17.2 Traceability of Distributed APIs and Intermediates17
12、.2已分发的原料药和中间体的可追溯性17.3 Quality Management17.3质量管理17.4 Repackaging, Relabeling, and Holding of APIs and Intermediates17.4原料药和中间体的重新包装、重新贴签和待检17.5 Stability17.5稳定性17.6 Transfer of Information17.6 信息的传达17.7 Handling of Complaints and Recalls17.7 投诉和召回的处理17.8 Handling of Returns17.8 退货的处理18. Specific Gu
13、idance for APIs Manufactured by Cell Culture/Fermentation18. 用细胞繁殖/发酵生产的原料药的特殊指南18.1 General18.1 总则18.2 Cell Bank Maintenance and Record Keeping18.2细胞库的维护和记录的保存18.3 Cell Culture/Fermentation18.3细胞繁殖/发酵18.4 Harvesting, Isolation and Purification18.4收取、分离和精制18.5 Viral Removal/Inactivation steps18.5 病毒
14、的去除/灭活步骤19. APIs for Use in Clinical Trials19.用于临床研究的原料药19.1 General19.1 总则19.2 Quality19.2 质量19.3 Equipment and Facilities19.3 设备和设施19.4 Control of Raw Materials19.4 原料的控制19.5 Production19.5 生产19.6 Validation19.6 验证19.7 Changes19.7 变更19.8 Laboratory Controls19.8 实验室控制19.9 Documentation19.9 文件20. Glossary20. 术语Q7a GMP Guidance for APIsQ7a原料药的GMP指南1. INTRODUCTION1. 简介1.1 Objective1.1目的This document is intended to provide guidance regarding good manufacturing practice (GMP) for the manufacturing of active pharmaceutical ingredients (APIs) under an appropriate system
