Almac Clinical Services milestone achievement as full GMP compliance achieved across global sites
December 1, 2008
Almac Clinical Services announces the completion of a successful inspection of its Durham, NC operations by the UK Medicines and Healthcare products Regulatory Agency (MHRA).
This was the final inspection covering the group’s main sites for clinical supplies and follows those performed at their Craigavon (UK) and Audubon (PA) facilities within the last 4 months.
The voluntary inspection, which occurred on 21st and 22nd November 2008, observed that the Durham site was fully compliant with EU Good Manufacturing Practices, with no critical or major failures noted.
Commenting on the global significance of the inspections, Paul O’Connor (Vice President, Quality) said:
“The inspection at our Durham site is the third and final outcome in demonstrating global GMP compliance for Almac Clinical Services. Once again we have proven our company wide attitude towards a total quality ethos and this has been reflected in the results of the recent inspections. I would like to thank all of our staff for their hard work towards achieving this success.”
Robert Dunlop, President, Almac Clinical Services, added
“Congratulations to all staff across our three sites who have put significant effort into the design and implementation of our quality systems. This result gives our client base an assurance of high standards and consistency across all of our operational sites. Quality is one of Almac’s core values and we use the strength of our systems, facilities and people to differentiate ourselves in the marketplace.”
About Almac Clinical Services
Almac Clinical Services is a global company focused on clinical trial supply solutions, with sites in Craigavon (UK), Audubon (PA, USA) and Durham (NC, USA). Almac Clinical Services enables clients to meet their trial start dates by leveraging skilled and experienced personnel coupled with robust quality systems and operational flexibility. Services provided include blinding, packaging, labelling, global distribution, QP release, analytical testing, drug supply management and online randomisation.
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.
+44 28 38 363857