Vetter has been granted a permanent Manufacturer’s Authorization for its clinical development facility located in Rankweil, Austria. This site has been in operation for nearly two years, and the Austrian Agency for Health and Food Safety (AGES), the overseeing national regulatory authority, conducted a reevaluation to issue the permanent authorization. Prior to its official commissioning, the authority had conducted an initial inspection at the end of 2021, resulting in a standard temporary Manufacturer’s Authorization for two years, in accordance with Austrian protocols.
During the comprehensive three-day inspection, AGES inspectors gained a thorough understanding of Vetter's operational procedures at the site. The primary focus was on validating processes and documentation in both production and quality control, as well as assessing the quality assurance systems in place. The inspectors were highly impressed with the facility's infrastructure, systems, and operational processes.
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