FDA-GMP中英文对照标准版(共93页).docx

精选优质文档-倾情为你奉上DIRECTION OF GMP (GOOD MANUFACTURING PRACTICE )OF RAW MATERIALS BY FDATable of Contents目录1. INTRODUCTION1.1 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总则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产品质量审核3. PERSONNEL