Pharmiweb has reported that Almac has achieved success in MHRA inspections at both their Craigavon Headquarters, Northern Ireland and Elvingston, Scotland sites. These 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 laboratory facility in support of their IMP license. Following the MHRA’s acceptance of Almac’s response report, Almac’s licence 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 the 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.
President and Managing Director, Stephen Barr commented on the successful audits saying:
“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 recognised in this way, and adds further credibility to our wealth of experience and services we offer.”