文档介绍：Q7a ( 中英文对照) FDA 原料药 GMP 指南 Table of Contents 目录 1. INTRODUCTION 1. 简介 Objective 目的 Regulatory Applicability 法规的适用性 Scope 范围 2. QUALITY MANAGEMENT 2. 质量管理 Principles 总则 Responsibilities of the Quality Unit(s) 质量部门的责任 Responsibility for Production Activities 生产作业的职责 Internal Audits (Self Inspection) 内部审计(自检) Product Quality Review 产品质量审核 3. PERSONNEL 3. 人员 Personnel Qualifications 3. 人员的资质 Personnel Hygiene 人员卫生 Consultants 顾问 4. BUILDINGS AND FACILITIES 4. 建筑和设施 Design and Construction 设计和结构 Utilities 公用设施 Water 水 Containment 限制 Lighting 照明 Sewage and Refuse 排污和垃圾 Sanitation and Maintenance 卫生和保养 5. PROCESS EQUIPMENT 5. 工艺设备 Design and Construction 设计和结构 Equipment Maintenance and Cleaning 设备保养和清洁 Calibration 校验 EC_Q7a 2 Systems 计算机控制系统 6. DOCUMENTATION AND RECORDS 6. 文件和记录 Documentation System and Specifications 文件系统和质量标准 Equipment cleaning and Use Record 设备的清洁和使用记录 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 Master Production Instructions (Master Production and Control Records) 生产工艺规程(主生产和控制记录) Batch Production Records (Batch Production and Control Records) 批生产记录(批生产和控制记录) Laboratory Control Records 实验室控制记录 Batch Production Record Review 批生产记录审核 7. MATERIALS MANAGEMENT 7. 物料管理 General Controls 控制通则 Receipt and Quarantine 接收和待验 Sampling and Testing of ing Production Materials 进厂物料的取样与测试 Storage 储存 Re-evaluation 复验 8. PRODUCTION AND IN-PROCESS CONTROLS 8. 生产和过程控制 Production Operations 生产操作 Time Limits 时限 In-process Sampling and Controls 工序取样和控制 Blending Batches of Intermediates or APIs 中间体或原料药的混批 Contamination Control 污染控制 9. PACKAGING AND IDENTIFICATION LABELING OF APIs AND INTERMEDIATES 9. 原料药和中间体的包装