CGMP Release Testing Now Available In France
Drug manufacturers in the EU looking for FDA-approved biologics QC testing services have a new option in Châtillon, France. The site, which was already approved to provide in vivo EU-GMP quality control release testing, including pyrogenicity and toxicity, is now also registered with the US Food and Drug Administration as a CGMP QC facility. The registration allows Châtillon to perform release testing for drugs in the US market according to current good manufacturing practices, like our Ballina, Ireland site.
“Our operations and quality assurance teams have been working hard the past several months to ensure our services comply with CGMP requirements,” said Benjamin Ville, Biologics France Responsible and Qualified Person (QP). “Registering with the FDA will enable us to further support the needs of our customers around the world.”
The FDA registration further enhances the available portfolio of biologics testing services available, which includes research and development testing (immunization studies with animal models) and GMP QC release tests (pyrogen, toxicity, insulin, etc.) conducted in compliance with several pharmacopeias around the world including US, EU, Japan, Russia and China.