Almac Pharma Services, part of the global CDMO, 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 230,000 sqft site 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 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."
Responding to the news, Graeme McBurney, Managing Director & President of Almac Pharma Services said: "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."