PCI is the first CDMO to undergo ICMRA’s inspection pilot program.
PCI Pharma Services (PCI), a leading global contract development and manufacturing organization (CDMO), has successfully completed the International Coalition of Medicines Regulatory Authorities (ICMRA) inspection of its Bedford, New Hampshire campus. In doing so, PCI becomes the first drug product CDMO to navigate the multi-agency inspection process, a facet of the ICMRA’s new Collaborative Hybrid Inspection Pilot (CHIP) program, which is focused on the mutual assessment of facilities that manufacture therapies under the organization’s purview.
The new ICMRA program is designed to abbreviate the time necessary to receive regulatory approvals from multiple countries. Regulatory agencies from several countries can convene for one inspection as a team, allowing CDMOs such as PCI to attain approval from each of the participating ICMRA countries simultaneously rather than undergo separate, phased inspections. For this pilot inspection, two agencies conducted the inspection – one onsite and the other virtually – while an additional five regulatory bodies observed virtually.
“We’re honored to have been selected as the first CDMO to participate in the ICMRA’s pilot program, allowing for agencies across the globe to conduct their regulatory approval process simultaneously,” said Tom McGrath, VP, Global Quality for Manufacturing & Development at PCI Pharma Services. “The program’s collaborative, comprehensive process increases the speed at which CDMOs or sponsoring pharma companies can begin manufacturing, packaging and ultimately commercializing life-changing therapies.”
PCI’s Bedford campus specializes in sterile fill-finish and lyophilization, two manufacturing processes commonly used with injectable and biologic therapies. PCI recently invested over $100 million in infrastructure enhancements at the site, building upon legacy disciplines toward its current destination: a multi-product, multi-capabilities campus servicing prominent pharma companies, across the drug product lifecycle from development to commercialization. Since PCI’s Bedford campus manufactures a broad array of drugs for both domestic and international markets, the site was an ideal candidate for the multi-agency inspection pilot program.
“At PCI, we are dedicated to bringing lifechanging therapies to patients as expediently as possible, and this welcome new program will further enhance our ability to do exactly that,” said Salim Haffar, CEO of PCI Pharma Services. “The ability to simultaneously gain approval from multiple, geographically diverse regulatory agencies is a game-changing, fast-tracking boost for the pharma industry, providing shorter paths to full-fledged sterile drug product production and commercialization, to the ultimate benefit of pharma companies and the patients they serve.”
