Global CDMO PCI Pharma Services has successfully completed an International Coalition of Medicines Regulatory Authorities (ICMRA) inspection of its New Hampshire, US site.
This makes PCI the first drug product CDMO to be a part of the multi-agency inspection process, which is an offshoot of the ICMRA’s new Collaborative Hybrid Inspection Pilot (CHIP) programme.
The initiative focuses on the mutual assessment of facilities that manufacture therapies under the organisation’s eye.
The idea is to accelerate the regulatory approval process through the convergence of regulatory boards from several countries participating in the scheme; this means the organisation can simultaneously attain approval from each respective board.
“We’re honoured to have been selected as the first CDMO to participate in the ICMRA’s pilot programme, allowing for agencies across the globe to conduct their regulatory approval process simultaneously,” said PCI Pharma’s VP of Global Quality for Manufacturing & Development, Tom McGraph.
“The programme’s collaborative, comprehensive process increases the speed at which CDMOs or sponsoring pharma companies can begin manufacturing, packaging and ultimately commercialising life-changing therapies.”
The Bedford, New Hampshire site specialises in sterile fill-finish and lyophilisation for injectables and biologics.
PCI invested around USD $100m into the infrastructure of the site, which is set up to serve both the domestic and international markets.
CEO of PCI Pharma Services, Salim Haffar, added: “The ability to simultaneously gain approval from multiple, geographically diverse regulatory agencies is a game-changing, boost for the pharma industry, providing shorter paths to full-fledged sterile drug product
production and commercialisation.”
