Novasep, a provider of manufacturing solutions for life science molecules and fine chemicals, announces that the U.S. Food and Drug Administration 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, an anticancer parenteral active ingredient for which Novasep is a supplier. The positive outcome of the audit in Le Mans confirms that the company is suited to handle highly potent active pharmaceutical ingredients, in particular paclitaxel. Novasep has held European Certificate of Suitability for paclitaxel since 2011 and an FDA drug master file since 1996.
The Leverkusen facility audit included both a pre-approval inspection of the production of formulated nitroglycerine and an overall cGMP inspection on all products made for the U.S. market.
“The FDA has tightened up its surveillance and audits,” says 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,” says Jean-Claude Romain, VP of quality at Novasep. “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.”
The Le Mans site produces highly potent cytotoxic pharmaceutical ingredients and registered advanced intermediates, either for commercial purposes or clinical development. The facility has synthesis and chromatography purification suites in contained areas, enabling the handling of highly potent pharmaceutical ingredients with Occupational Exposure Limits below three micrograms/m3 per 8 hours.
The site in Leverkusen, equipped with modernized machinery, has operated chemical syntheses and in particular hazardous chemistries on an industrial scale for 140 years. Novasep holds Drug Master Files for several APIs including nitroglycerin and numerous formulations, as well as a European CEP for nitroglycerin-ethanol solution. Hazardous chemistries enable the design of shorter synthetic routes for producing APIs and advanced intermediates.
Novasep’s offering includes process development services, purification equipment and turnkey processes, contract manufacturing services, and complex active molecules to serve pharmaceutical, biopharmaceutical, fine chemical, food, and functional ingredients as well as bio-sourced chemicals and bio-industries.
Release Date: October 22, 2013