Pace Life Sciences, a U.S.-based contract development and manufacturing organization, announced the completion of a European Medicines Agency (EMA) Good Manufacturing Practice (GMP) inspection at its Lebanon, New Jersey facility, which is advancing small and large molecule programs from early development through commercialization.

Part of the EU GMP certificate renewal process, the inspection earlier this month assessed the site’s quality systems and laboratory operations including stability programs, equipment qualification, sample receipt and management, employee training, corrective and preventive actions (CAPA), analytical procedures, data packages, as well as container closure integrity testing activities. 

Pace expects a renewed EU GMP certificate to be issued to the 40,000-square-foot facility, which provides analytical testing and development support for pharmaceutical and biopharma companies including container closure integrity testing (CCIT), stability testing, analytical method development and validation, and microbiology testing.

In April, Pace opened an expanded microbial limits testing laboratory at its Lebanon site, significantly increasing throughput, efficiency, and reliability within an established microbial limits testing program. With the added capacity, the company said it can now support higher sample volumes while “continuing to uphold the highest standards of quality and regulatory compliance.”

In July, Pace announced the successful completion of a U.S. Food and Drug Administration (FDA) inspection of its Small Molecule Center of Excellence in Research Triangle Park, North Carolina. Last year, the company’s San German, Puerto Rico site received a positive FDA Inspection of its quality systems and client data delivery processes.