Novasep has successfully audited two of its European custom manufacturing sites in Le Mans, France and Leverkusen, Germany.
FDA investigators audited the two facilities in June and July 2013.
The FDA audit at the Novasep site in Le Mans was a pre-approval inspection for production of paclitaxel, a long-established anticancer parenteral active ingredient for which Novasep is one of the world’s leading suppliers.
The positive outcome of the audit in Le Mans demonstrates the capability of the team to handle highly potent active pharmaceutical ingredients (HPAPI), in particular paclitaxel.
Novasep has held European CEP (Certificate of Suitability) for paclitaxel since 2011 and an FDA drug master file (DMF) since 1996.
The Leverkusen facility audit included both a pre-approval inspection of the production of formulated nitroglycerine and an overall cGMP (Good Manufacturing Practices) inspection on all products made for the US market.
“The FDA has tightened up its surveillance and audits,” said Michel Spagnol, CEO at Novasep. “Adhering to regulatory requirements is critical, although it is becoming progressively more challenging across the industry. Our teams’ commitment to quality is impressive. I am very pleased with our continued track record in securing FDA inspection approval and the added assurance these successes give our global customers.”
“The two successful FDA inspections demonstrate that Novasep’s custom synthesis facilities are operated under a robust quality management system,” said Jean-Claude Romain, VP of quality at Novasep.
Romain continued, “A quality assurance system does not remain static. It constantly evolves due to experience, multiple customer feedback and regulatory inspections. In addition, FDA inspections provide excellent opportunities for further improvement. The successes of the audits not only result from the quality systems Novasep has in place, but also from the day-to-day involvement of each person on the team.”