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The inspections took place at the company’s Charnwood, UK, Craigavon, Northern Ireland, and Audubon, PA, locations.
Almac Pharma Services, part of the contract pharmaceutical development and manufacturing organization of the United Kingdom-based Almac Group, announced the completion of three regulatory GMP inspections across three facilities in a span of two weeks.
According to a Sept. 25, 2019 press release, the successful inspections took place at the company’s Charnwood, UK, Craigavon, Northern Ireland, and Audubon, PA, locations. Each inspection resulted in no critical or major findings from the UK’s Medicines & Healthcare products Regulatory Agency (MHRA) or FDA and no FDA Form 483’s issued.
The 230,000-ft2 Charnwood site 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 by MHRA of the site’s quality systems resulted in no critical or major findings.
Operations carried out at the company’s global headquarters in Craigavon include GMP and non-GMP pharmaceutical development, commercial-scale manufacturing and packaging of solid-oral-dose material, and secondary labeling, serialization, and distribution of drug product globally. The inspection was also successful with no 483 issued.
For the Audobon facility, FDA performed an unannounced inspection. The facility provides a range of specialized 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.
“It is unprecedented for the Almac Pharma Services business to have three regulatory authority inspections within such a short period of time,” said Ian Markwell, vice-president of quality, Almac, in the press release. “It is a great credit to the skilled and experienced teams involved across all locations that they resulted in a positive outcome.”
Almac will be exhibiting at Booth 121C42 at CPhI Worldwide, taking place Nov. 5–7, 2019 in Frankfurt, Germany.