Our quality management covers the whole process of our production. The responsibilities of quality control, quality assurance and regulatory affairs are well defined. The established quality management system bases on national guidelines and international GMP requirements. It handles the process of all quality relevant processes.

    

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• US-FDA-accepted drug production according cGMP: 2002, 2008, 2011 and 2014
• International custermer audits: Europe, Japan and USA
• Accreditation by the Korean Health Authority KFDA: 2012
• Accreditation by the Japanese Health Authority MHLW: 2007
• National Health Authority (GMP-certificat): 2015
• Quality- und environmental management system according to: DIN EN ISO 9001:2008 and DIN EN ISO 14001:2009 (DIN EN ISO 14001:2004 int.)
• Energy conscious company according §3 SpaEfV

• ICH Q 7-Good Manufacturing Practice for Active Pharmaceutical Ingredients Manufacturer (EU GMP Leitfaden)
• WHO-Good Trade and Distribution Practice of Pharmaceutical Starting Materials