Almac Pharma Services Achieves Unprecedented Global Regulatory Milestone
Craigavon, U.K., 25 Sep 2019 Almac Pharma Services, part of the global contract pharmaceutical development and manufacturing organisation, the Almac Group, has announced the successful completion of three global regulatory GMP inspections across three facilities in the space of just two weeks.
The UK MHRA conducted a routine GMP audit at the company’s Charnwood, UK facility. The 230,000ft2 site, based in Loughborough, was acquired by Almac in 2015 and provides GMP development and manufacturing of solid oral dose clinical trial materials and small scale commercial volumes. The three day inspection of the site’s quality systems resulted in no critical or major findings.
Meanwhile, the company’s global HQ site in Craigavon, Northern Ireland was received a general GMP inspection by the US FDA. Operations carried out at this site include GMP and non-GMP pharmaceutical development, commercial scale manufacturing and packaging of solid oral dose material, secondary labelling, serialisation and distribution of drug product globally. The inspection was also successful with no 483 issued.
Finally, the US FDA performed an unannounced inspection at the company’s Audubon, PA, USA facility which provides a range of specialised commercial packaging services including complex kit assembly for medical devices, combination products and biologic packs. The inspection covered general aspects of GMP and the company’s operations with biologic products and, again, closed with no 483 being issued.
Ian Markwell is the VP of Quality and has overall responsibility for the company’s global regulatory compliance. He said: “It is unprecedented for the Almac Pharma Services business to have three regulatory authority inspections within such a short period of time. It is a great credit to the skilled and experienced teams involved across all locations that they resulted in a positive outcome."
With over 50 years’ experience and a wealth of expertise providing flexible, quality-led pharmaceutical solutions Almac was pleased to achieve complete success across all three sites confirming that no critical or major observations were raised throughout.
Responding to the news, Graeme McBurney, Managing Director & President, Almac Pharma Services commented “ We recognise that quality determines the extent of our success and therefore place a high priority on ensuring our company-wide quality systems not only meet, but exceed, global regulatory standards. Successful completion of these inspections at our multiple global facilities reflects our ongoing commitment to quality and teamwork across the entire organisation. We are dedicated to investing further in our innovative systems thereby ensuring our clients continue to receive superior services enabling them to bring important new treatment to patients throughout the world.”
About Almac Group
’Partnering to Advance Human Health’
The Almac Group is an established contract development and manufacturing organisation providing an extensive range of integrated services across the drug development lifecycle to the pharmaceutical and biotech sectors globally. Our innovative services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IRT (IVRS/IWRS) through to commercial-scale manufacture.
The international company is a privately owned organisation that has grown organically over the past five decades now employing over 5,000 highly skilled personnel across the US (Pennsylvania, North Carolina and California) and Asia (Singapore and Tokyo).