Switzerland-based Carbogen Amcis AG, a pharmaceutical process development and Active Pharmaceutical Ingredient (API) manufacturing company, has announced that its site in Vionnaz has successfully completed a Swissmedic inspection performed by Regional Medicines Inspectorate of Western Switzerland (ISOPTh).
The two-day inspection took place from September 20 to 21, 2022, and was undertaken by an inspector of Regional Medicines Inspectorate of Western Switzerland (ISOPTh) at the Vionnaz, Switzerland, site. The routine inspection covered the Quality Management System compliance and no critical deviations were raised.
It’s a great achievement for our Vionnaz site and rewards the constant, excellent work and commitment to quality of our dedicated team, maintaining our successful audit history
This inspection continues a series of successful inspections by Swissmedic in Vionnaz, with the first inspection in 2015 followed by 2016, 2017 and 2020.
“I am very pleased by the positive outcome of the inspection,” said Pascal Villemagne, CEO of Carbogen Amcis. “It’s a great achievement for our Vionnaz site and rewards the constant, excellent work and commitment to quality of our dedicated team, maintaining our successful audit history.”
The facility was acquired by Carbogen Amcis in 2014 and is designed to develop and manufacture highly potent active pharmaceutical ingredients (API) including the capability to produce highly potent warheads and linkers for antibody drug conjugates (ADC).