Vetter, a leading global Contract Development and Manufacturing Organization (CDMO), has received the permanent Manufacturer’s Authorization for its clinical development site in Rankweil, Austria. Operational for nearly two years, the responsible national regulatory authority, the Austrian Agency for Health and Food Safety (AGES) again inspected the site for issuance of a permanent Manufacturer’s Authorization. Before commissioning the site, the authority had already carried out an initial inspection at the end of 2021, which resulted in a temporary Manufacturer’s Authorization for two years, as is customary in Austria.
The AGES inspectors gained deep insights into Vetter’s methods of work at the site during the three-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.
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