Almac Clinical Services completed a successful inspection of its Durham, NC operations by the UK Medicines and Healthcare products Regulatory Agency (MHRA). This marked the final inspection covering the group’s main sites for clinical supplies and follows inspections performed at the Craigavon, UK and Audubon, PA facilities within the last four months.
The voluntary inspection, which occurred in November 2008, observed that the Durham site was fully compliant with EU GMPs, with no critical or major failures noted, according to an Almac statement.
Paul O’Connor, vice president, quality at Almac Clinical Services, commented, “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, the group's president, 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.”
Almac Clinical Reaches Full GMP Compliance
Published December 10, 2008
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