3 APIC 供应商资格和管理指南 200912.pdfVIP

ACTIVE PHARMACEUTICAL INGREDIENTS COMMITTEE (APIC) SUPPLIER QUALIFICATION MANAGEMENT GUIDELINE December 2009 Content 1. Introduction 2. Chapter 1: Supplier Selection 3. Chapter 2: Due Diligence 4. Chapter 3: Quality Assessment 5. Chapter 4: Change Control + Production Assessment 6. Chapter 5: Supply Chain Security 7. Chapter 6: Ongoing Monitoring and Evaluation 8. Appendices Appendix 1: Examples of Critical/ non Critical Raw Materials Appendix 2: Supplier Selection Check List Appendix 3: Due Diligence Check List