PCI Pharma Services’ Bedford, NH Facility Excels in International Medicines Regulatory Inspection
PCI Pharma Services, a renowned global contract development and manufacturing organization (CDMO), has achieved a significant milestone with the successful completion of the International Coalition of Medicines Regulatory Authorities (ICMRA) inspection at its Bedford, New Hampshire campus. This accomplishment marks PCI as the first drug product CDMO to undergo the multi-agency inspection process, a key component of ICMRA’s new Collaborative Hybrid Inspection Pilot (CHIP) program focused on evaluating facilities that manufacture therapies under the organization’s supervision.
The ICMRA program aims to streamline the regulatory approval process across multiple countries, reducing the time required to obtain necessary approvals. By allowing regulatory agencies from various countries to conduct a joint inspection, CDMOs like PCI can secure approval from each participating ICMRA country simultaneously, eliminating the need for separate inspections conducted in phases. In the recent pilot inspection conducted at PCI’s Bedford campus, two agencies performed the inspection – one on-site and the other virtually – while an additional five regulatory bodies observed virtually.
Tom McGrath, VP of Global Quality for Manufacturing & Development at PCI Pharma Services, expressed his appreciation for being selected as the inaugural CDMO to partake in the ICMRA’s pilot program. He highlighted the collaborative and comprehensive nature of the program, emphasizing its ability to expedite the regulatory approval process, allowing CDMOs and pharmaceutical companies to commence manufacturing, packaging, and commercializing transformative therapies at an accelerated pace.
Specializing in sterile fill-finish and lyophilization processes commonly used in injectable and biologic therapies, PCI’s Bedford campus recently underwent over $100 million in infrastructure enhancements. These investments have further solidified the site as a multi-product, multi-capabilities campus catering to prominent pharmaceutical companies across the drug product lifecycle, from development to commercialization. Given the site’s extensive manufacturing of a diverse range of drugs for both domestic and international markets, it was a fitting candidate for the multi-agency inspection pilot program.
Salim Haffar, CEO of PCI Pharma Services, underscored the organization’s commitment to delivering life-changing therapies to patients in a timely manner. He lauded the new program for its potential to enhance efficiency in the pharmaceutical industry, offering expedited pathways to full-scale sterile drug product production and commercialization. This accelerated approval process from multiple regulatory agencies worldwide is poised to benefit pharmaceutical companies and the patients they serve.
PCI Pharma Services stands out as a leading CDMO, providing clients with comprehensive drug development, manufacturing, and packaging solutions that accelerate product launches and enhance commercial success. With a track record of over 90 successful product launches annually and more than five decades of experience in the healthcare sector, PCI operates across 30 sites in seven countries, employing over 7,000 professionals dedicated to bringing life-saving therapies to patients.
Through cutting-edge technology and ongoing investments, PCI Pharma Services addresses global drug development needs throughout the product lifecycle, from manufacturing capabilities to clinical trial supply chain management and commercialization. By partnering closely with clients, PCI serves as an extension of their businesses, working collaboratively towards the common goal of improving patients’ lives through innovative therapies.
In conclusion, PCI Pharma Services’ achievement in successfully navigating the ICMRA’s inspection process exemplifies the organization’s commitment to excellence in pharmaceutical manufacturing and regulatory compliance. By participating in the groundbreaking CHIP program, PCI has demonstrated its readiness to embrace innovative approaches that streamline regulatory processes and accelerate the delivery of vital therapies to patients worldwide.
