Almac Charnwood Commercial Manufacturing Plant Successfully Passes FDA Inspection
The pre-approval pertains to a solid oral dose product that the CDMO will manufacture for a global pharmaceutical company.
Almac Pharma Services, part of the Almac Group that serves as a contract development and manufacturing organization (CDMO), has successfully completed its first FDA inspection of its commercial manufacturing facility in Charnwood, England.1 The successful FDA inspection is the latest Almac Pharma Services’ site to receive this aforementioned FDA approval, as it joins the list of current FDA-approved facilities, including company’s global HQ in Craigavon, Northern Ireland; Dundalk, Ireland, and Audubon, PA in the United States.
The pre-approval inspection occurred over a five-day span and pertained to a solid oral dose product that the plant will produce for a global pharmaceutical company. The FDA’s verdict was that the facility, systems, and practices comply with the FDA’s set of requirements; there were no Form 483 observations or comments reported.The site currently has over 250 highly skilled and experienced employees on its staff, while offering various oral dose development and manufacturing services pertaining to high potency options.
“This milestone underscores our commitment to maintaining the highest quality standards and regulatory compliance enabling us to consistently deliver best-in-class services to our clients,” said Ian Markwell, Almac Pharma Services’ VP of quality. “With this achievement, we continue to strengthen our position as a trusted, reliable and stable partner as we work together to advance human health for the sake of patients in need.”
In other news, the previously referenced Craigavon headquarters completed the construction of two new purpose-built facilities back in March of this year.2 The expansion project—a multi-million-dollar endeavor—features significant growth for two of the company’s business units, Almac Pharma Services and Almac Sciences.
The first project revolves around a 32,000 square-foot Almac Pharma Services facility that will house new large-scale manufacturing suites. These are expected to boost commercial manufacturing and packaging of sachet drug product presentations. The company’s QC laboratory testing capabilities will also be expanded.
As for the second project, a 28,000 square-foot good manufacturing practice (GMP) facility will reportedly more than double Almac Sciences’ peptide active pharmaceutical ingredient (API) manufacturing capacity.
“… Our new peptide API manufacturing facility will significantly grow our portfolio of client APIs and is the latest stage of a wider development and manufacturing expansion initiative for Almac Sciences,” noted Graeme McBurney, Almac Group’s COO. “The business has also recently opened a new technology development center, installed additional small molecule API GMP reactors, and opened a dedicated chemical warehouse.
“In the drug product service arm of our business, Almac Pharma Services is adding to its large-scale commercial manufacturing and packaging capabilities in response to growing demand for tailored solutions to meet clients' market growth needs. This allows us to support our clients throughout a drug’s lifespan, from early development through to commercialization.”
References
1. Almac Pharma Services Announces Successful FDA Inspection at Charnwood, UK Facilities. Almac. July 23, 2024. Accessed July 26, 2024. https://www.almacgroup.com/news/almac-pharma-services-announces-successful-fda-inspection-at-charnwood-uk-facilities/
2. Saraceno N. Almac Group Grows Northern Ireland HQ, Welcomes New Facilities. Pharmaceutical Commerce. March 7, 2024. Accessed July 26, 2024. https://www.pharmaceuticalcommerce.com/view/almac-group-grows-northern-ireland-hq-welcomes-new-facilities
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