CellGenix received ISO 9001:2008 certification
CellGenix’ quality management system was certified in April 2012 on the requirements of DIN EN ISO 9001:2008 standard by the TÜV Rheinland Cert GmbH. To highlight CellGenix’ commitment to quality and service the certification of ISO 9001:2008 covers all relevant functions of the company, development, production, storage and distribution of CellGenix’ Ex Vivo Therapeutics, i.e. growth factors, serum-free media and cell culture systems.
“With more than 15 years of experience in GMP cell processing and over 10 years in GMP production of recombinant protein pharmaceuticals, production and quality control have always been under regulatory surveillance of authorities. The implementation of the requirements of ISO 9001:2008 has improved structuring of our daily tasks in all work areas and documents our total quality approach,” said Dr. Stefan Thoma, CellGenix’ Director Quality Management.
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