Almac Group Announces Successful MHRA Inspection at Charnwood Facilities
October 23, 2017
Craigavon, N.I., UK, 23 October 2017 – Almac Group, the Craigavon-based global contract pharmaceutical development and manufacturing organization, is pleased to announce the successful inspection by the UK Medicines and Healthcare products Regulatory Agency (MHRA) of its new Pharmaceutical Development & Manufacturing facilities at Charnwood Campus, Loughborough.
In November 2015, to meet ongoing client demand, Almac Group announced the expansion of its pharmaceutical development & manufacturing services with the acquisition of a significant proportion of the 70-acre Charnwood Campus in Loughborough, England – a world-class science, technology and enterprise park. Since that announcement the facilities have undergone significant investment both in building enhancements and the installation and validation of new processing and analytical technology.
This successful MHRA inspection provides Almac Pharma Services with the necessary licenses to develop, manufacture and pack non-potent and potent, solid oral drug products for clinical trials and commercial supply at the Charnwood site, with the new facility complementing the existing development & GMP services offered from the company’s Craigavon NI Headquarters.
Trevor Clarke, Global Head of Quality Systems commented, “We are extremely pleased with the successful roll-out of our Global Quality Management System to the new Charnwood site. This positive endorsement by the MHRA provides our clients with increased capacity governed by the same pharmaceutical quality system which they are already familiar with at our existing sites in Craigavon, Northern Ireland and Audubon, Pennsylvania.”
Graeme McBurney, Managing Director, Almac Pharma Services commented: “This is a great achievement and positive reflection of both the investment Almac has made in the site and of our staff operating the facilities. We are looking forward to beginning work for our clients at these world class facilities and already have committed projects which will commence in the coming months.”
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 almost 50 years and now employs in excess of 5600 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with operations in the UK, Ireland, across the US (Pennsylvania, North Carolina and California) and in Asia (Singapore and Tokyo).