PCI Pharma Services, a Philadelphia-based contract development and manufacturing organization (CDMO), announced in a press release on Aug. 21, 2024 that its Bedford, NH campus successfully completed the multi-agency inspection process of the International Coalition of Medicines Regulatory Authorities (ICMRA), making PCI the first drug CDMO to navigate this particular facet of ICMRA’s new Collaborative Hybrid Inspection Pilot (CHIP) program. The process of the CHIP program that PCI took part in, according to the company, involved a “mutual assessment” of the facilities that manufacture therapies under the organization’s purview.
PCI said it recently invested more than $100 million in infrastructure enhancements at the Bedford site, which manufactures a wide range of drugs for domestic as well as international markets. While the company specializes in sterile fill/finish and lyophilization, its stated goal is to serve leading pharmaceutical companies across the drug product lifecycle, from development to commercialization.
“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,” Tom McGrath, PCI vice president of global quality for manufacturing and development, said in the press release. “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.”
Elaborating on the ICMRA process, it is designed to shorten the necessary time to garner regulatory approvals in multiple countries, allowing agencies from several different countries to participate jointly in one inspection. For CDMOs like PCI that complete the program successfully, this can mean approval in one instance, from all ICMRA participant countries, rather than a phased series of inspections.
