ichqa原料药(中英文)文档.docVIP

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(s) 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 APIs AND INTERMEDIATES 9. 原料药和中间体的包装和贴签 9.1 General