NEW YORK, June 30 - Agencourt Bioscience said today that an outside party has audited its facilities and confirmed them to be in compliance with the FDA's Good Laboratory Practices (GLP) guidelines.
Brendan McKernan, vice president of manufacturing and operations for Agencourt, told GenomeWeb that the genomic services firm brought in Omega PharmServices to benchmark its facilities against the FDA's 21 CFR part 58 regulations, which cover good laboratory practice for nonclinical laboratory studies.
The GLP guidelines regulate quality assurance audits, preventive maintenance and training programs, sample tracking and laboratory information systems, and other analytical laboratory practices. "A lot of these things we've done for a number of years," said McKernan. "We just had to get an outside agency to say that we were actually compliant."
"This has really been driven by our customers," McKernan added. "They're looking to integrate the supply chain into guidelines that they have to follow from a regulatory standpoint."
McKernan said that all of Agencourt's current services have been deemed GLP compliant, and that the company expects to launch additional compliant product lines within the next several months.