Vetter has received the permanent Manufacturer’s Authorisation for its clinical development site in Rankweil, Austria.
Operational for nearly 2 years, the national regulatory authority, the Austrian Agency for Health and Food Safety (AGES), has once again inspected the site to issue a permanent Manufacturer’s Authorisation.
Before commissioning the site, the authority had already done an initial inspection at the end of 2021, which resulted in a temporary Manufacturer’s Authorisation for 2 years ... as is customary in Austria.
The AGES inspectors gained deep insights into Vetter’s methods of work at the site during the 3-day inspection.
The focus was on the verification of the processes and the documentation in the production and quality control as well as on the systems for quality assurance.
The inspectors were impressed with the premises, systems and processes on site.
"We are very happy and proud of the result of this comprehensive inspection conducted by the AGES. Our state-of-the-art facility in Austria features structured and modern systems and processes and our staff members bring high expertise,” says Wolfgang Weikmann, Vetter’s Senior Vice President Quality.
“This allows us to provide clinical trial materials of consistently high quality to our customers worldwide, helping to develop life-enhancing medication for patients in need.”
Vetter Development Service Rankweil represents the company’s European counterpart to its clinical manufacturing site near Chicago.
“Our Austrian site allows us to further expand our capacity and service offering to our customer base in the crucial field of process development and clinical manufacturing of Phase I and II injectables,” says Dr Claus Feussner, Vetter’s Senior Vice President of Development Service.
“The site's successful reinspection and the receipt of the permanent Manufacturer's Authorisation is yet another important milestone in our strategic company development."