Switzerland-based CARBOGEN AMCIS AG, a pharmaceutical process development and Active Pharmaceutical Ingredient (API) manufacturing company, announced that its Vionnaz site has successfully completed a Swissmedic inspection.
Swissmedic conducted the inspection (general surveillance audits) over two days, on December 12-13, 2017 at Vionnaz, Switzerland. The inspection covered the Quality System related to the development and manufacture of highly potent APIs, including Analytical and Quality Control. No significant concerns were discovered during the inspection, which will result in the renewal of the GMP-certificates for the site.
“This inspection follows the first audit by Swissmedic in 2016 for the cGMP certification after we acquired this site,” said Martin Schneider, Chief Quality Officer at CARBOGEN AMCIS. “This successful inspection underscores CARBOGEN AMICS’ track record of high quality development and manufacturing. Our other facilities in Switzerland also successfully passed a series of audits last year; FDA audit in October 2017 for the Bubendorf (Headquarters) and Swissmedic inspections for the sites in Bubendorf, Neuland and Aarau in July 2017. ”
CARBOGEN AMCIS is a leading service provider, offering a portfolio of drug-development and commercialization services to the pharmaceutical and biopharmaceutical industry at all stages of drug development. The integrated services provide innovative chemistry solutions to support timely and safe drug development, allowing customers to make the best use of available resources.