Pace Life Sciences has completed a European Medicines Agency (EMA) GMP inspection at its Lebanon, New Jersey facility, supporting the renewal of the site's EU GMP certificate.
The inspection took place on October 13-14, 2026, as part of the renewal process for the 40,000-square-foot pharmaceutical analytical testing laboratory.
Pace Life Sciences, a US-based, FDA-registered GMP testing laboratory and CDMO, said that it expects a renewed certificate to be issued following the inspection.
The EMA assessment covered the facility's quality systems and laboratory operations, including the following:
- stability programmes
- equipment qualification
- sample receipt and management
- employee training
- corrective and preventive actions (CAPA)
- analytical procedures
- data packages
- and container closure integrity testing (CCIT).
According to Lou Forcellini, VP of Quality Assurance at Pace Life Sciences, the outcome reflects the team's commitment to operational excellence and its ability to work within international regulatory frameworks.
Our customers rely on defensible analytical data to bring safe, effective therapies to patients worldwide.
The Lebanon facility provides analytical testing and development support to pharma and biopharma companies, with capabilities spanning CCIT, stability testing, analytical method development and validation, plus microbiology testing.
Its services support both small- and large-molecule development programmes.
An expansion of analytical testing capabilities
The successful EMA inspection follows several developments across Pace Life Sciences' US operations during the past year, as the company continues to invest in its analytical testing infrastructure and regulatory capabilities.
In April, the company opened an expanded microbial limits testing laboratory at its Lebanon facility.
The upgraded laboratory increased testing capacity and throughput, enabling the site to accommodate higher sample volumes while strengthening its existing microbiological testing services.
Then, in July, Pace Life Sciences also announced the successful completion of an FDA inspection at its Small Molecule Center of Excellence in Research Triangle Park, North Carolina.
The company said the inspection reinforced its focus on quality systems, regulatory compliance and data integrity across its analytical operations.
The firm subsequently appointed Andrew Fenny as President of Pace Life Sciences in August. Fenny, who brings more than 20 years of pharmaceutical and CDMO leadership experience, was appointed to oversee the division's strategic growth and expand support for pharmaceutical and biotechnology customers across its network of eight sites.
The latest inspection outcome adds to these efforts the company has already made this year, reinforcing the Lebanon facility's role in supporting pharma development programmes and providing analytical services to customers operating across international markets.
