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Almac Introduces QP Program for EU Trials

Aims to expedite release process

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Almac has introduced the Qualified Person (QP) Facilitation Program for global clients importing investigational medicinal products (IMP) into the EU for clinical trials. The solution aims to alleviate the complex logistical hurdles surrounding the QP Release process, as well as provide enhanced consulting during this stage of clinical trial distribution.
 
Through the program, an Almac Quality Compliance Manager will be placed at the client site to explain the release processes and to define the responsibilities for both the sponsor and Almac. The manager also provides supply chain assessment, assembly and completion of relevant documentation for QP Release, and a better understanding of all information pertaining to the QP release process.
 
“The QP Facilitation Program, through face-to-face interaction, will work to eliminate issues with the QP Release process and effectively remove the preparation for QP Release from the critical path,” said Paul O’Connor, global vice president Quality at Almac. “We believe this service to be a tremendous benefit to clients with limited internal resources or those unfamiliar with the QP Release process.”

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