PCI’s Bedford Plant Completes ICMRA Inspection
The company also participated in the coalition’s pilot inspection program, making it the first CDMO to do so.
PCI Pharma Services (PCI), a contract development and manufacturing organization (CDMO), has completed the International Coalition of Medicines Regulatory Authorities (ICMRA) inspection of its Bedford, NH campus.1
According to PCI, this accomplishment makes it the first drug product CDMO to complete the multi-agency inspection process, which is a component of the ICMRA’s new Collaborative Hybrid Inspection Pilot (CHIP) program. This initiative focuses on the assessment of facilities that product therapies under the organization’s supervision.
The CDMO most recently committed over $100 million in infrastructure enhancements into the site.2
ICMRA’s new program is intended to shorten the time that’s required receive regulatory approvals from multiple countries. Now, regulatory agencies representing multiple countries are able to have one inspection done as a team. By that reasoning, CDMOs can now receive approval from each of the participating ICMRA countries all at once, instead of undergoing separate inspections.
PCI also participated in a pilot inspection conducted by two agencies: one onsite and the other virtually. Five additional regulatory bodies also 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, 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, which are often used during the injectable and biologic therapy processes. This particular campus manufactures a various drugs for both the domestic and international markets.
“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,” commented 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.”
References
1. PCI Pharma Services’ Bedford, New Hampshire Location Successfully Completes International Coalition of Medicines Regulatory Authorities Inspection. PCI Pharma Services. August 22, 2024. Accessed August 30, 2024. https://pci.com/pci-bedford-location-successfully-completes-icmra-inspection/
2. Saraceno N. PCI Pharma Services Begins Expansion Project. Pharmaceutical Commerce. May 9, 2024. Accessed August 30, 2024. https://www.pharmaceuticalcommerce.com/view/pci-pharma-services-begins-expansion-project
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