US FDA audits are a lot tougher than customer inspections according to CMO Regis, which has just passed two agency assessments with no 483 observations.
Regis’ GMP manufacturing facility, QC laboratory and quality systems were inspected as part of the FDA’s unannounced week-long visit.
Louis Glunz, CEO of Regis Technologies, told Outsourcing-Pharma.com, “Unlike a customer audit, the FDA can ask anything and they really go a lot deeper” than a customer would.
When customers audit Regis’ facilities, “it’s usually two auditors over two days in pre-announced audits. We probably do between eight and 12 annually and they can look through all of the validation records and SOPs [standard operating procedures],” Glunz said. Once companies agree to work with Regis, they “usually don’t audit us again.
“We serve innovative small companies which have projects that depend a lot on their stock prices and project management,” Glunz said. He noted that project cancellations are not that frequent, though in 2009 “there was a real fear” of more cancellations because of the economic recession.
Chicago, US-based Regis provides synthesis, separations and manufacturing services to pharmaceutical and biotechnology companies from its cGMP (current good manufacturing practices) facilities. It works with customers to advance high value intermediates and active pharmaceutical ingredients from initial process development and scale-up through final validation and commercial manufacturing.
“Our main thing is GMP manufacturing, but chiral separations are our special angle,” he noted.
Regulators from Brazil, Korea and Japan have also audited the Regis facilities, though Japan’s was strictly a paper audit, he added.
Regis continually updates its 36,000 square foot facility that currently includes laboratories and production capabilities with eight bioreactor suites, individual kilo lab suites, a cryogenic reactor and a quality control department.
Glunz continued, “The FDA has also recognized and approved Regis’ profile as a Control Testing Lab, which means that our testing results can be used in our customers’ FDA submissions without the requirement that Regis be inspected as a condition for acceptance. This gives our customers greater assurance that our work will not cause them any regulatory complications or delays.”