Transcription of SUPPLIER QUALIFICATION & MANAGEMENT GUIDELINE
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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.
ICH Q9 for their Quality Risk Management process and use the ICH Q9 definition of ... the GMP Guidelines. Manufacturers of medicinal products, APIs and registered intermediates for APIs are responsible for approving and qualifying their suppliers and to monitor on an ongoing basis the performance of their critical suppliers. ...
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