Pace Life Sciences has successfully completed a critical European Medicines Agency (EMA) Good Manufacturing Practice (GMP) inspection at its facility in Lebanon, New Jersey. This high-stakes assessment, conducted on October 13 and 14, 2026, marks a pivotal milestone in the company’s ongoing effort to renew its EU GMP certification, ensuring its continued eligibility to support international pharmaceutical supply chains.
The two-day audit provided a comprehensive review of the 40,000-square-foot site’s laboratory operations and quality management systems. EMA regulators scrutinized a wide range of operational pillars, including the laboratory’s stability programs, equipment qualification protocols, and sample management procedures. Furthermore, the inspection examined the facility’s rigorous standards regarding employee training, corrective and preventive actions (CAPA), analytical method development, and the integrity of data packages. Particular emphasis was also placed on the site’s container closure integrity testing (CCIT) capabilities, a vital service for maintaining the sterility and safety of pharmaceutical products.
Following the successful conclusion of the inspection, the company anticipates the formal issuance of a renewed EU GMP certificate. This certification is essential for Pace Life Sciences as it continues to provide a suite of analytical testing and development services—including microbiology testing and method validation—to a global portfolio of biopharmaceutical clients.
“Our customers rely on defensible analytical data to bring safe, effective therapies to patients worldwide,” said Lou Forcellini, VP of Quality Assurance at Pace Life Sciences. “This achievement reflects our team’s commitment to operational excellence and reinforces our ability to operate within rigorous international regulatory frameworks while delivering the reliable, high-quality data our clients depend on.”
The Lebanon facility serves as a critical hub in the Pace Life Sciences network, specializing in support for drug development and commercial release. By adhering to both U.S. and European regulatory standards, the company positions itself as a robust partner for manufacturers looking to navigate the complexities of global market entry.
This recent regulatory success follows a strong year of compliance milestones for the organization. In July 2026, Pace Life Sciences reported the successful completion of a U.S. Food and Drug Administration (FDA) inspection at its Small Molecule Center of Excellence located in Research Triangle Park, North Carolina.
The successful EMA inspection in New Jersey not only solidifies the site’s status as a top-tier laboratory but also underscores the broader strategy of Pace Life Sciences to maintain an unyielding focus on quality assurance. As the pharmaceutical industry continues to face heightened scrutiny from global health authorities, Pace’s ability to clear these rigorous evaluations provides its partners with the necessary assurance to move their drug candidates and commercial products into European markets without delay.
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