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The company has passed inspection by the UK Medicines and Healthcare products Regulatory Agency, and is now licensed to develop, manufacture, and pack non-potent and potent solid oral drug products at its site in Loughborough, England.
Almac Group, a pharmaceutical contract development and manufacturing organization, announced on Oct. 23, 2017 that its new pharmaceutical development and manufacturing facilities, located at the company’s Charnwood, Loughborough, England site, passed an inspection by the UK Medicines and Healthcare products Regulatory Agency (MHRA).
As a result of the MHRA inspection, the company is now licensed to develop, manufacture, and pack non-potent and potent solid oral drug products for clinical trials and commercial supply at the Charnwood site, with the new facility supplementing the existing development & GMP services offered at the company’s Craigavon, Northern Ireland headquarters.
Additionally, the Charnwood site, acquired by the company in November 2015, has been the focus of various investments by the company since its acquisition, including the installation and validation of new processing and analytical technology as well as building improvements.
“We are extremely pleased with the successful roll-out of our global quality management system to the new Charnwood site,” said Trevor Clarke, global head of quality systems, Almac Group, in a company press release. “This positive endorsement by the MHRA provides our clients with increased capacity governed by the same pharmaceutical quality system which they are already familiar with at our existing sites in Craigavon, Northern Ireland and Audubon, Pennsylvania.”
Source: Almac Group