Supply Chain Traceability of Medicinal Products

As per EUGMP requirements, EudraLex, Annex 16: Certification by a Qualified Person and Batch Release, the complete manufacturing and distribution supply chain of the medicinal product and its related active substance up to the stage of certification, should be documented and available for the Qualified Person (QP).

The entire supply chain of the drug product and active substance, upto stage of certification shall be available in the format of a comprehensive diagram which include manufacturing sites of starting materials and packaging materials and other critical components. It should also include subcontractors of each critical step like sterilisation of components / equipment if applicable. The Qualified Person (QP) is responsible for certifying that each batch of a medicinal product has been manufactured and tested in accordance with EU GMP principles before it is released for sale or distribution.

Practically the Supply Chain Traceability Map shall cover the drug product, manufacturer, subcontractors if any, key components of drug product and manufacturers of key components. Key components should cover active ingredients (APIs), inactive ingredients or excipients, primary packing materials. For APIs, it should also cover any key intermediates for which GMP is applicable if the key intermediate is not manufactured by the API manufacturer. That is if any of the steps after the regulatory key starting material (KSM) are not manufactured by the API manufacturer, it should be captured in the supply chain map. The supply chain traceability map should also cover Intermediaries involved in the drug supply chain such as any Repackager / Relabeler, European testing lab responsible for Batch Release testing, QP responsible for batch release, the European importer (MIA Holder), the European warehouse which store the imported product.

Templates – Qvents provides and easy to use template for mapping and presenting the supply chain tree and supply chain map.

Supply Chain Traceability Mapping Tool (Beta V1)

With multiple APIs, suppliers, excipients, packing materials etc for each drug product, mapping out the entire supply chain can be complex. Check out Qvents Supply Chain Traceability Mapping Tool (Beta V1) for generating the supply chain traceability tree and visual map.

Update the drug product name, details of the manufacturer, intermediaries involved in the drug supply chain such as any repackager / relabeller, the European testing lab, QP responsible for batch release, European importer (MIA Holder) and the authorised European warehouse for storage of the product. If any of the fields are not applicable leave it empty. Update the names of the APIs involved, name and address of manufacturer and details of any key intermediate if applicable. Update the details of excipients, primary packing materials and the manufacturers. Click on submit to get a detailed Supply Chain Traceability Tree as well as a Supply Chain Map. Check for any errors, correct the related fields and resubmit. In the Supply Chain Map move and adjust the nodes using mouse and cursor to get the best visual representation of the supply chain map.

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