Almac Group Announces Successful HPRA Inspection at its European Campus
October 2, 2018
Craigavon, N.I., UK, 02 October 2018 – Almac Group, the global contract pharmaceutical development and manufacturing organization, is pleased to announce the successful 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 labeling 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, Managing Director, Almac Pharma Services, commented: “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.”
About Almac Group
‘Partnering to Advance Human Health’
The Almac Group is an established contract development and manufacturing organization that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery development and commercialization, API manufacture, formulation development, clinical trial supply, IRT (IVRS/IWRS) through to commercial-scale manufacture.
The international company is a privately-owned organization that has organically grown over 50 years and now employs over 5,000 highly skilled personnel.
Almac is headquartered in Craigavon, Northern Ireland with 17 operations across Europe, the US (Pennsylvania, North Carolina and California) and Asia (Singapore and Tokyo).
Almac would like to acknowledge and thank all those organizations who have provided support over the last 50 years including Danske Bank, Invest NI, PWC and IDA.