FDAGMP中英文对照标准版.docxVIP

FDAGMP中英文比较标准版 FDAGMP中英文比较标准版 FDAGMP中英文比较标准版 精选文档 DIRECTION OF GMP (GOOD MANUFACTURING PRACTICE )OF RAW MATERIALS BY FDA Table of Contents 目录 INTRODUCTION 1.1 Objective 目的 1.2 Regulatory Applicability 法规的适用性 1.3 Scope 范围 2. QUALITY MANAGEMENT 质.量管理 2.1 Principles 总那么 2.2 Responsibilities of the Quality Unit(s) 质量部门的责任 2.3 Responsibility for Production Activities 生产作业的职责 2.4 Internal Audits (Self Inspection) 内部审计〔自检〕 2.5 Product Quality Review 产质量量审查 3. PERSONNEL人员 3.1 Personnel Qualifications 人员的资质 3.2 Personnel Hygiene 人员卫生 3.3 Consultants 顾问 1/92 精选文档 4. BUILDINGS AND FACILITIES建筑和设施 4.1 De