Successful inspection by MHRA of Almac Clinical Services’ Pennsylvanian facility
September 29, 2008
Almac Clinical Services is pleased to announce the completion of a successful inspection of its Audubon, Pennsylvania operations by the UK Medicines and Healthcare products Regulatory Agency (MHRA).
The voluntary inspection, which occurred on 15th and 16th September 2008, noted that the site was compliant with EU Good Manufacturing Practices, with no critical or major failures noted.
Commenting on the inspection, Paul O’Connor (Vice President, Quality) said:
“We are delighted with the results of this inspection. Almac has always strived to ensure that our procedures and processes meet the high standards set by the various international regulatory bodies. We find this is of great reassurance to our clients, who often require clinical services on a multi-site basis.”
“I wish to thank all of the staff involved for their efforts and dedication in providing a robust and transparent quality framework across all of the Almac Clinical Services sites.”
The MHRA is also inspecting Almac Clinical Services Durham (NC) and Craigavon (UK) facilities.
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The Almac Group comprises five closely integrated divisions offering a broad range of services from R&D, translational genomic services, API manufacture, product development, clinical trial supply and technology (IVRS/EDC), to commercial-scale manufacture. Almac provides services to over 600 companies including all the world leaders in the pharmaceutical and biotech sectors.
The company has almost 2,200 employees and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California. Construction of the company’s new $100m North American Headquarters started in July 08 and is expected to be completed 2010.
To find out more about Almac visit www.almacgroup.com