FDA-GMP中英文对照标准版教案.docxVIP

 PAGE \* MERGEFORMAT 92  DIRECTION OF GMP (GOOD MANUFACTURING PRACTICE )OF RAW MATERIALS BY FDA Table of Contents???目录 1. 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????人员 3.1 Personnel Qualifications??人员的资质 3.2 Personnel Hygiene???人员卫生 3.3 Consultants??????顾问 ?????? 4. BUILD