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SUPPLIER QUALIFICATION & MANAGEMENT GUIDELINE

ACTIVE PHARMACEUTICAL INGREDIENTS COMMITTEE (APIC) SUPPLIER QUALIFICATION & MANAGEMENT GUIDELINE December 2009 2 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 Appendix 4: SUPPLIER Questionnaires Appendix 5: Check list for Change Control Assessment 3 INTRODUCTION Manufacture of Medicinal Products and the Active Pharmaceutical Ingredients (APIs) used as starting materials in the production of these products is subject to strict good manufacturing practice regulations that are designed to ensure their quality, safety and efficacy.

Those that are widely commercially available and are used in multiple industries, for example acids, bases, solvents, filter aids, petroleum based raw materials, naturally ... The Regulatory Agencies will and do inspect the supplier qualification procedures used by medicinal product manufacturers and expect that they periodically audit their API

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