Almac Celebrates MHRA Audit Successes
January 23, 2012
Almac’s Sciences Business Unit has achieved dual success in MHRA inspections at both their Craigavon Headquarters, Northern Ireland and Elvingston, Scotland sites. Both inspections were the first biennial audits to confirm continued compliance with Investigation Medicinal Products (IMP) licenses and GMP certificates.
The first inspection audited Almac’s isotope chemistry facility in support of their IMP license. During the inspection, tours of the new manufacturing finishing suite and associated infrastructure, in support of the extended API facility were conducted.
Following the MHRA’s acceptance of Almac’s response report, Almac’s license will be applicable to both radiolabelled and non-labelled IMPs.
The second inspection covered Almac’s analytical laboratory in Elvingston, Scotland, supporting its GMP certificate as a contract analytical facility. The Inspector complimented Almac’s analytical team on their professionalism and laboratory high standards. As a result of this successful audit, two GMP certificates will be issued for human and veterinary applications.
Commenting on this dual success, President and Managing Director, Stephen Barr said:
“We are delighted with the outcome of these inspections. It is reassuring to know that the value we place on our staff and facilities is recognized in this way, and adds further credibility to our wealth of experience and services we offer.”
Alan Chambers, Head of Quality added,
“This success is just reward for the hard work and professionalism of the radiolabeling and analytical teams at both of our sites. We can all take pride in the success of these audits and their positive affirmation of the quality system to which all staff at Almac contribute.”
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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.