The Medicines and Healthcare products Regulatory Agency (MHRA), which was asked by Almac to conduct the inspection, confirmed that the Durham facility fully complies with all European Union good manufacturing practice (GMP) rules.
Almac’s North Carolina facility, which is located in the Southern city of Durham, is the hub of the firm’s packaging and distribution operations for both candidate drug products and clinical trial supplies shipped around the world.
With the continued growth of clinical trial services in China and India, companies like Almac are keen to emphasise the quality of their offerings and focus on gaining approval from regulators worldwide in order to maintain a market advantage.
The MHRA decision completes the clean sweep of approvals gained by Almac facilities in Craigavon in the UK and Audubon, Pennsylvania, adding to similar GMP status issued by the US Food and Drug Administration (FDA).
Paul O’Connor, Almac’s global head of quality for clinical trial services, told in-PharmaTechnologist that while both Durham and Audubon are outside the firm’s jurisdiction, it believes “the clean bill of health will provide further reassurance for customers”.
He explained that: “For clients, drug candidates are their baby and they often have only one chance to conduct trials. Our part is to receive [the] package and distribute in a manner that complies with the rules governing trials and therefore welcome the chance to emphasise the quality of our service.”
O’Connor also said that MHRA approval for its US facilities was a distinct advantage for Almac as it would help its customers gain the qualified person clearance that is required for all clinical trial materials used in Europe.