Carbogen Amcis, a leading pharmaceutical process development and active pharmaceutical ingredient (API) manufacturing company, announces the successful completion of the first US Food and Drug Administration (FDA) pre-approval inspection (PAI) at its Vionnaz facility in Switzerland. The inspection concluded without the issuance of a Form 483.
The FDA conducted the inspection from 7-11 September as part of the regulatory review of a product manufactured at the site. The inspection covered key aspects of the product and its manufacturing process, including manufacturing and batch documentation, process validation, equipment qualification, analytical method validation, cleaning validation, supplier qualification, change control, deviations, corrective and preventive actions (CAPAs), and training.
Acquired by Carbogen Amcis in 2014, the Vionnaz facility specialises in the development and small-scale manufacture of highly potent APIs, including warheads and linkers for antibody-drug conjugates. The site has dedicated process development, production and quality control facilities.
