The Active Pharmaceutical Ingredients Committee (APIC) has released a new guide to provide guidance and suggests a harmonized approach within the API industry on how to manage suppliers of materials and services.

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This new guideline replaces the 2009 APIC guide “Supplier Qualification & Management Guideline” and looks at supplier management primarily from a quality perspective, but also covering other real-life aspects, such as dealing with suppliers that are reluctant to sign quality agreements or to accept physical audits.

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Throughout the document is highlighted that a risk management approach is an integral part of today’s supplier management processes and that the Quality Unit has a crucial role in overseeing all quality and compliance related aspects and has the exclusive authority to approve or reject suppliers.

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The guideline focuses mainly on the following topics:

• The four stages of Supplier Management Life Cycle (Selection, Qualification, Operation and Termination);
• Risk management applied to Supplier Management;
• Quality Agreements;
• Auditing, emphasizing how this is one of the most powerful tools to assess whether the supplier effectively meets the requirements, being particularly important during the initial qualification.

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We feel that this document can provide valuable inputs to Medicinal Product Manufacturers and on how to handle their suppliers.

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As for Owlpharma, the year of 2023 marked a definitive return to on-site audits and even a return to Chinese manufacturing plants. From the 47 audits performed at API manufacturers since the beginning of 2023 until last month (April 2024), the non-conformities are mainly related to the following chapters of Eudralex Vol. 4 – Part II (and when applicable, the correspondent annexes):

The overall compliance level of the API manufacturers does not evidence significant changes from the pre-pandemic levels.

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Despite the majority of API manufacturers are currently being audited on-site once again, the COVID-19 pandemic brought the development of a new robust and effective tool for supplier qualification, the off-site audits and we believe that this tool will remain important in the upcoming years to give valuable, cost and time-effective information which will support our risk assessments and as a safeguard against any climate or geopolitical crisis, scenarios which probably will have an impact in our near future and in the way we organize supplier qualification.

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Remote audits can also be of extreme importance when qualifying less critical suppliers (e.g. excipient and packaging material manufacturers).

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You can know more about our available audit reports and planned audits so far through our database Audit Search.

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