Almac Introduces Qualified Person Facilitation Program
June 13, 2012
Program vastly simplifies and expedites the QP release process
Almac is pleased to announce the Qualified Person (QP) Facilitation Program; 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, labeling and global distribution of clinical supplies. Directly, the on-site QP Facilitation Program 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 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.”
By participating in the QP Facilitation Program, Almac clients will find the QP Release process more straightforward and accomplish necessary documentation in a more timely fashion.
Notes to Editors
The Almac Group provides a broad range of services from R&D, biomarker discovery and development, API manufacture, formulation development, clinical trial supply and IXRS® technology (IVRS/IWRS), to commercial-scale manufacture. Almac provides services to more than 600 companies, including all the world leaders in the pharmaceutical and biotech sectors. The company employs over 3,300 individuals and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California.