The recent successful inspection will enable the CDMO to support analysis of commercial drug products and provide flexible secondary labelling and packaging solutions
Almac Group, the global contract pharmaceutical development and manufacturing organisation, has successfully passed an inspection of its Almac Pharma Services 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.
In January, Almac 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.
Ian Markwell, VP of Quality, commented: “We are extremely pleased with this inspection outcome. 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, President and 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.”