Almac Introduces QP Facilitation Programme for Conducting Trials in the European Union
Almac has announced the Qualified Person (QP) Facilitation Programme; a value-add enhancement to Almac’s current suite of QP services.
Offered to global clients importing investigational medicinal products (IMP) into the European Union for clinical trial, this solution has been developed to alleviate the complex logistical challenges surrounding the QP Release process as well as provide a deeper level of consulting during this critical stage of clinical trial distribution.
This latest addition to the Almac portfolio is complementary to the already extensive range of services including packaging, labelling and global distribution of clinical supplies.
Directly, the on-site QP Facilitation Programme enhances Almac’s QP services portfolio which currently includes regulatory guidance, global auditing and import testing.
To simplify and expedite the often complicated QP Release process, an Almac Quality Compliance Manager will be placed at the client site in order to explain the release processes and to clearly define the responsibilities for both the sponsor and Almac.
Features of the program include access to a dedicated Quality Compliance Manager on-site that provides supply chain assessment, assembly and completion of relevant documentation necessary for QP Release, and an overall better understanding of all information pertaining to the QP release process.
In addition to reducing the burden of handling this process internally, clients will receive unique, study specific guidance from an experienced Quality Compliance Manager who is an expert in the QP Release process.
“The QP Facilitation Programme, 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.
Paul continued, “We believe this service to be a tremendous benefit to clients with limited internal resources or those unfamiliar with the QP Release process.”
By participating in the QP Facilitation Programme, Almac clients will find the QP Release process more straightforward and accomplish necessary documentation in a more timely fashion.