- Almac Pharma Services successfully completed its first FDA inspection at its Charnwood, England facility with no observations.
- The inspection was related to a solid oral dose product for a global pharmaceutical company.
Almac , has announced the successful completion of its first US Food and Drug Administration (FDA) inspection at its commercial manufacturing facility in Charnwood, England. The pre-approval inspection, which spanned five days, was conducted for a solid oral dose product that the site will manufacture for a global pharmaceutical company. The FDA inspector concluded that the facility, systems, and practices comply with FDA requirements, with no Form 483 observations or comments reported.
The Charnwood facility, acquired by Almac Pharma Services in 2015, is located within the Charnwood Campus in Loughborough. Since its acquisition, the site has seen significant growth and now employs over 250 skilled individuals. The facility specialises in the development and manufacturing of high potency and age-appropriate oral dose treatments.
This FDA inspection marks a milestone for Almac Pharma Services as it is the final site within the company to receive FDA approval. This achievement complements the existing FDA-approved facilities at the company’s global headquarters in Craigavon, Northern Ireland, Dundalk, Ireland, and its US facility in Audubon, Pennsylvania. It underscores the company’s commitment to maintaining high-quality standards across its product development, manufacturing, and commercialisation services.
Ian Markwell, Vice President of Quality at Almac Pharma Services, 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.”
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