Qualifications of the Establishment

• GMP-Status - Good Manufacturing Practice (inspected by national authorities and FDA)
• Accreditation according to DIN EN ISO/IEC 17025
• Certification according to DIN EN ISO 14001-2005 (Environmental Management)
• Officially accredited center for the analysis of water in accordance with Article 15 (4) TrinkwV 2001 (Drinking Water Regulations, Germany)
• Permission in accordance with Article 3 BtmG (Federal Narcotics Act, Germany) and Article 7 GüG (Federal Raw Material Monitoring Act, Germany)
• Official examination center for control tests of pharmaceuticals in accordance with Article 65 (4) AMG (Medicines Act, Germany)
• Authorization in accordance with Article 44 IfSG (Infection Control Act, Germany)
• Authorized training center for the expert pharmacist for pharmaceutical analysis
• Authorized training center for the expert veterinarians for microbiology
• FDA approved (5 x audited, last audit: May 2009)

Responsible inspecting authority:
Center for pharmaceuticals monitoring Bavaria at the government of Upper Bavaria.


Here you can find a Pdf version of our GMP, respectively accreditation certificate:

GMP Certificate [Pdf of the cover sheet]

Accreditation Certificate [Pdf of the cover sheet]


Questions?

The staff of our Quality Assurance is glad to assist you.