PCI Pharma Services’ Bedford, NH Location Successfully Completes International Coalition of Medicines Regulatory Authorities Inspection
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.
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.
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