The Medicine Maker Spotlights CARBOGEN AMCIS’ New GMP-compliant Site in France
CARBOGEN AMCIS recently earned GMP certificate for its sterile drug product site in Saint-Beauzire, France, following a successful inspection by the French health authority, ANSM.
In an interview with The Medicine Maker, Julie Pagenaud, Director of Pharmaceutical Operations, shared insights into the rigorous certification process.
The inspection evaluated critical aspects such as quality systems, aseptic process simulation, risk assessment, Annex 1 compliance, technology transfer, and facility readiness. One of the major challenges was maintaining production while simultaneously preparing a new team and infrastructure for its first GMP inspection.
Check out Julie’s full interview in The Medicine Maker article.