Q7a中英对版.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 Util