The MHRA has given Almac’s Northern Ireland clinical services facility and its new ERP system a thumbs-up after an inspection carried out this month.
The Medicines and Healthcare products Regulatory Agency (MHRA) concluded that the site in Craigavon had maintained its track record of compliance with European Union (EU) good manufacturing practices (GMP) standards.
Almac VP of quality Paul O’Connor said the latest inspection is even more significant that previous MHRA visits because “as it comes at an exciting time as we prepare to implement our new multi-million pound ERP system.
The enterprise resource planning system (ERP) is intended to give Almac purchasing control for all of its products and services as well as inventory management capabilities for its 'lean' manufacturing and quality control operations.
O’Connor explained that: “This [the ERP] was reviewed intensively – one and a half days in total during the inspection period and resulted in no findings - testimony to our confidence that this exciting new development will further enhance our position as the premium supplier of global clinical supply chain solutions to the Pharmaceutical and Biotech industries.”
The last 12 months have been a busy period for Almac’s clinical services team in Northern Ireland in terms of both expansion and investment, beginning in December when the firm launched its Compass trial supply management tool.
The tech, offered under Almac’s supply chain management services, enables pharma supply managers to forecast ingredient, packaging, labelling and distribution requirements based on clinical trials recruitment rates and projections.
The following month the opened a new packaging and distribution services building for trial supplies HQ to coordinate the distribution of candidate drugs for trials to its network of 32 depots around the world.
Most recently Almac added refrigerator capacity at the Craigavon site in a bid to winner more business from the increasing number of drug industry customers developing temperature sensitive pharmaceutical products.
At the time Martin Lamb, VP of Business Development, said: “Our suite of leading cold chain solutions is a response to the growing customer demand for clinical services for temperature sensitive materials.”