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Almac Completes HPRA Inspection at its European Campus

10.26.18

Can now support analysis of commercial drug product and provide flexible secondary labelling and packaging solutions

Almac Group has successfully passed the inspection of Almac Pharma Services (Ireland) at its European campus in Dundalk, Ireland, by the Health Products Regulatory Authority (HPRA).
 
Almac Group previously confirmed that the premises secured in Dundalk as part of its ongoing global expansion strategy were successfully inspected by the HPRA in January 2018. This initial inspection provided Almac with the regulatory approvals to conduct QP certification of both clinical and commercial drug product from its European campus in Dundalk.
 
Since January, Almac has made an investment of £10 million to establish state-of-the-art analytical laboratories and commercial packaging suites to ensure current and future client needs within the European Union are met. 
 
This recent inspection by the HPRA now enables Almac Pharma Services to support analysis of commercial drug product and provide flexible secondary labelling and packaging solutions for a wide range of finished pack presentations. 
 
“We are extremely pleased with this inspection outcome,” said Ian Markwell, vice president of quality, Almac. “Not only does this illustrate the strength of our Global Quality Management System but provides assurance to our client partners that we meet all EU regulatory requirements.”
 
Graeme McBurney, managing director, Almac Pharma Services, said, “This is a great achievement and reflects Almac’s commitment to provide our global client partners with an uninterrupted service provision and seamless access to the EU marketplace. Regardless of the outcome of Brexit negotiations, we look forward to providing best in class, bespoke packaging solutions, from this new European facility.”