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.

manufacturing practice regulations that are designed to ensure their quality, safety and efficacy. This ensures that patients worldwide and at any time can have confidence in the quality, safety and efficacy of medicines. The cGMP regulations for final medicinal products are clearly defined in each country and region.

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  Guidelines, Practices, Manufacturing, Manufacturing practices

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