White Paper

Utilization Of Customs Warehouses In The Clinical Trial Supply Chain

Source: Marken

The global clinical trial supply chain industry has been seeking new opportunities to improve efficiency for many years. As pressures to decrease cost and reduce time to market continue to rise, the design of the clinical trial supply chain must evolve and change to meet those demands. A European Union (EU) based customs-bonded warehouse may provide solutions for reducing costs while optimizing distribution throughout the clinical trial supply chain.

Each time a batch of investigational medicinal products (IMPs) is brought into the EU, compliance with EU good manufacturing practices (GMP) must be certified by the qualified person (QP) of the import authorization holder. The QP must review all manufacturing documents to verify that the manufacturer and IMP comply with EU GMP requirements before IMPs can be imported and distributed.

The QP review process is time consuming and requires requests for original batch paperwork and additional information for full review. In many cases audits of the manufacturing facility must be conducted, which can result in significant additional costs. This QP certification and release to the trial is required for all pharmaceuticals even when intended for export to non-EU countries.