Almac Pharma Services, a pharmaceutical development, manufacturing and services company, has successfully completed its first US Food and Drug Administration (FDA) inspection.
The assessment was carried out on its commercial manufacturing facility in Charnwood, UK — with the main focus of the inspection being the cGMP capability of the site to produce an undisclosed solid oral dose product.
Upon completion, the FDA inspector concluded that the facility, systems and practices were FDA compliant, with no Form 483 observations or comments reported.
Since the company’s acquisition of the Charnwood facility in 2015, the site has undergone significant growth, with 250 skilled individuals now working on its premises.
The site provides a range of oral dose development and manufacturing capabilities, with a strong focus on high potency treatment options.
This approval complements the previous successful FDA inspections at its Craigavon, Dundalk and Audubon sites.
Almac Pharma Services’ Vice President, Quality, Ian Markwell commented: “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. 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."
[Photo credit: Charnwood Campus]
