Vetter's Newest Facility Successfully Completes FDA Inspection
Center for visual inspection and logistics sets high safety and control standards
Ravensburg, Germany, March 27, 2013 / B3C newswire / – Vetter, a leading contract development and manufacturing organization (CDMO), announced today that its new center for visual inspection and logistics passed its first GMP inspection by the U.S. Food and Drug Administration (FDA). The inspection was conducted March 11 through 14 to ensure the facility is in compliance with good manufacturing practices. The facility was already granted manufacturing approval and cGMP certification for Europa from the RP Tuebingen, Germany in 2012.
The 18,000-square-meter facility, known as Ravensburg Vetter West (RVW), began operations in April 2012. The site provides high-bay warehousing for cold storage and room-temperature products, as well as visual inspection. Featuring state-of-the-art technology, which helps adapted to the needs of the separate supply and manufacturing processes, RVW also harnesses extensive use of renewable energy sources, including photovoltaic and geothermal.
"We're pleased with the outcome of Ravensburg Vetter West's first FDA GMP inspection," said managing director Thomas Otto. "We at Vetter work diligently to meet regulatory requirements. Maintaining high quality standards is a job we take seriously to be a reliable and efficient partner for our customers."
Vetter is a leading contract development and manufacturing organization (CDMO) that specializes in the aseptic filling of syringes, cartridges and vials. The company has extensive experience with biologics and other complex compounds, including monoclonal antibodies, peptides, interferons and vaccines. Its clientele includes the world's top 10 pharma/biotech firms and emerging companies alike. A full-service provider, Vetter supports products throughout their lifecycles, from preclinical development through global market supply. Through its U.S. and European facilities, Vetter Development Service provides state-of-the-art support for early-stage products, with seamless transfer at Phase III to Vetter Commercial Manufacturing for large-scale production. The company is the originator of dual-chamber technology, which enables easier, safer lyophilized-drug administration; and is a leader in the use of RABS technology in cleanrooms, which mitigates risk of product contamination during the manufacturing process. Vetter has won numerous awards for innovation and quality, including top prize at the 2012 European Outsourcing Awards for its new high-speed filling line. Headquartered in Ravensburg, Germany, the company employs approximately 3,000 staff across Europe and the United States.
Vetter Pharma International GmbH
Phone: +49 (0)751-3700-3023
Fax: +49 (0)751-3700-7707
E-mail: [email protected]