Q7a中英对照版.doc

Q7a（中英文对照）FDA原料药GMP指南Table of Contents??目录1. INTRODUCTION??1. 简介1.1 Objective??1.1目的1.2 Regulatory Applicability??1.2法规的适用性1.3 Scope??1.3范围??2. QUALITY MANAGEMENT??2.质量管理2.1 Principles??2.1总则2.2 Responsibilities of the Quality Unit??2.2质量部门的责任2.3 Responsibility for Production Activities??2.3生产作业的职责2.4 Internal Audits (Self Inspection)??2.4内部审计（自检）2.5 Product Quality Review??2.5产品质量审核?3. PERSONNEL??3. 人员3.1 Personnel Qualifications??3.人员的资质3.2 Personnel Hygiene??3.2 人员卫生3.3 Consultants??3.3 顾问4. BUILDINGS AND FACILITIES??4. 建筑和设施4.1 Design and Construction??4.1 设计和结构4.2 Utilities??4.2 公用设施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 卫生和保养?5. PROCESS EQUIPMENT??5. 工艺设备5.1 Design and Construction??5.1 设计和结构5.2 Equipment Maintenance and Cleaning??5.2 设备保养和清洁5.3 Calibration??5.3 校验5.4 Computerized Systems??5.4 计算机控制系统6. DOCUMENTATION AND RECORDS??6. 文件和记录6.1 Documentation System and Specifications??6.1 文件系统和质量标准6.2 Equipment cleaning and Use Record??6.2 设备的清洁和使用记录6.3 Records of Raw Materials, Intermediates, API Labeling and Packaging Materials??6.3 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 Batch 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 Records??6.6 实验室控制记录6.7 Batch Production Record Review??6.7批生产记录审核7. MATERIALS MANAGEMENT??7. 物料管理7.1 General Controls??7.1 控制通则7.2 Receipt and Quarantine??7.2接收和待验7.3 Sampling and Testing of Incoming Production Materials??7.3 进厂物料的取样与测试 7.4 Storage??7.4储存7.5 Re-evaluation??7.5复验8. PRODUCTION AND IN-PROCESS CONTROLS??8. 生产和过程控制8.1 Production Operations??8.1 生产操作8.2 Time Limits??8.2 时限8.3 In-process Sampling and Controls??8.3 工序取样和控制8.4 Blending Batches of Intermediates or APIs??8.4 中间体或原料药的混批8.5 Contamination Control??8.5 污染控制?9. PACKAGING AND IDENTIFICATION LABELING OF API