Supply Chain Management and the QP

In today’s pharmaceutical industry and increasing globalisation of Pharmaceutical Supply Chains, the supply chain often extends across multiple transportation routes and regulatory jurisdictions, and may include sourcing pharmaceuticals from outside of the EU/EEA for distribution within the EU/EEA, or sourcing pharmaceuticals from within the EU/EEA and distributing globally.

Annex 16 of the EU GMP Guide requires that documented information on the entire supply chain of the medicinal product, starting from the manufacturing sites of the starting materials and components, and including all parties involved in any manufacturing and importation activities of the medicinal product, is made available for the QP in order for the QP to certify the pharmaceutical product for release to market or for export. Annex 16 also requires QP certification of pharmaceutical product for products imported into the EU/EEA or for products manufactured within the EU/EEA for export and distribution globally.
For All QPs:

  • How well do you know your supply chain? Assess your knowledge, control and visibility of your supply chain responsibilities. Annex 16 applies to IMP and commercial product.

  • Do you have a Diagrammatic Representation of the supply chain? Is this sufficiently detailed to give you visibility on all the actors in the chain?

  • Does the supply chain map include the API, high and medium risk excipients, intermediates, bulk and finished product transportation, storage and distribution facilities, and associated activities?

  • Is there a risk assessment and the countermeasures designed to minimize the potential for falsified medicines to be introduced into the supply chain?

  • What parties are involved in which activities at each stage of the chain?

  • Who is the original manufacturer of the API, Excipient, Product?

  • Who has responsibility for each 3rd party? MAH vs WDA vs MIA Holder

  • Where are the raw materials coming from (API, Excipients, Intermediates, Bulk drug and packaging etc.)?

  • What is expected travel time to destination including stop overs?

  • Are interim or stop-over storage locations licensed appropriately?

  • Is the product packaging validated appropriately?

  • How is the temperature of the shipment controlled? Is it validated appropriately?

  • How is the humidity controlled (for sensitive products)?

  • Are the logistic providers GDP compliant?

  • Re brokers involved? Are they registered appropriately? Are they GDP compliant?

  • Are roles and responsibilities between all parties within the supply chain formally captured in written agreements?

What ever your supply chain need or challenge, we always welcome the opportunity to speak with you. Contact us by email to set up an introductory discussion, or visit our website