Qa中英对照.docVIP

EC_Q7a PAGE  PAGE 82 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 Audits (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 Lighting4.5 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 Documentation 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 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 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 Production 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