International Inspection Successfully Completed at PCI Pharma Services New Hampshire Campus

Communication between the manufacturing plant and retail stores. | Image Credit: © Cagkan - stock.adobe.com

The Bedford, NH campus of PCI Pharma Services, a Philadelphia-based contract development and manufacturing organization (CDMO), has successfully completed the multi-agency inspection process of the International Coalition of Medicines Regulatory Authorities (ICMRA), as announced in a press release on Aug. 21, 2024, making PCI the first drug CDMO to navigate this particular facet of ICMRA’s new Collaborative Hybrid Inspection Pilot (CHIP) program (1). 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 (1). 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 (1). 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.

PCI said that in its particular case, one country conducted an onsite inspection while another did so virtually, and another five countries also virtually observed.

“At PCI, we are dedicated to bringing life-changing 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, in the press release. “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.”

In June 2024, Pharmaceutical Technology® and BioPharm International® spoke with Jeff Clement, executive director of technical sales for manufacturing and development at PCI Pharma Services, about the challenges and benefits of incorporating robotics into aseptic manufacturing. That video interview in its entirety, plus additional information on the topic, can be viewed here (2).

References

1. PCI Pharma Services. PCI Pharma Services’ Bedford, New Hampshire Location Successfully Completes International Coalition of Medicines Regulatory Authorities Inspection. Press Release. Aug. 21, 2024.
2. Haigney, S. Robotics in Sterile Processing. PharmTech.com, June 3, 2024.