APIC: Best Practices Guide for dealing with Suppliers

Recommendation

22 October 2024
Vienna, Austria

Pre-Conference Session to the 27th APIC/CEFIC Global GMP & Regulatory API Conference - in Vienna or online
From theory to practice: Implementing API Process Knowledge

The "Best practices guide for managing suppliers of API manufacturers" was finalised by the "APIC Supplier Management Task Force" in March 2024 and is now available on the APIC website. It emerged from the document "Supplier Qualification and Management Guideline", which was first published in 2009, and now replaces it in its entirety. The previous document has been completely revised, although the original annexes have been retained and an additional Annex 2 entitled "Commitment declaration (template)" has been added.

The new guide contains the following chapters and sub-chapters:

1. General Section
    1.1 Introduction 
    1.2 Objectives
    1.3 Scope
    1.4 Overall Process for Supplier Management

2. Supplier Management
    2.1 Selection Phase
    2.2 Qualification Phase
    2.3 Operational Phase
    2.4 Termination Phase

3. Risk Management applied to Supplier Management
    3.1 Risk management process
    3.2 Risk Identification and Analysis
    3.3 Risk Evaluation and Risk Review
    3.4 Risk control

4. Auditing
    4.1 General
    4.2 Audit organisation
    4.3 Audit Types
    4.4 Audit rating
    4.5 Refusal of audits

5. Quality agreements
    5.1 General
    5.2 Refusal or partial acceptance of agreements

6. Definitions and abbreviations
7. References
8. Annexes
9. Version History

Please find the details in the "Best practices guide for managing suppliers of API manufacturers" and in the respective annexes.