Pharmaceutical process development and Active Pharmaceutical Ingredient (API) manufacturer, CARBOGEN AMCIS, has successfully completed an inspection of its Vionnaz facility by Swissmedic. By passing the process, the manufacturer has proven its compliance with high regulatory standards.
CARBOGEN AMCIS.
CARBOGEN AMCIS' Vionnaz facility.
The Swiss Agency for Therapeutic Products completed the two-day inspection from November 13 to 14, 2024. The inspection, led by an inspector from the Regional Medicines Inspectorate of Western Switzerland (ISOPTh), was primarily focused on ensuring compliance with the Quality Management System for the development and manufacture of highly potent APIs.
“This successful inspection underscores our track record of delivering high-quality development and manufacturing services. It reflects the unwavering commitment of our team to consistently meet the highest quality standards required for the site,” said Hélène Mazuel, Quality Director - Drug Substance at CARBOGEN AMCIS, Switzerland. “I am immensely proud of the Vionnaz team for this achievement, supported by our expert groups across Switzerland. Demonstrating our ability to meet all aspects of quality to Swissmedic is a significant milestone that further strengthens our reputation.”
The Vionnaz facility, which specialises in the development and small-scale production of highly potent APIs (up to category 5), has previously completed inspections in 2015, 2016, 2017, 2020, and 2022.