Quality Management


ISO 9001 Quality System

ISO 9001:2000 certification serves as the basis for all our internal processes. With respect to production of raw raq materials or final kits, this means

  • detailed documentation (SOPs, central documentation)
  • batch records with full traceability of all parameters
  • independent QC and QA department
  • change control procedures
  • complaint handling procedures
  • education and training programs
  • supplier evaluation program
  • maintenance and calibration program

Products manufatured under cGMP

In order to address special needs in Molecular Diagnostics and Pharma Processing certain products are produced under cGMP. In brief, our GMP system encompasses the following aspects

  • Validation
    • equipment
    • processes incl. filling
    • QC procedures (extended testing)
    • stability programs
    • cleaning procedures, dedication concept
  • Hygienic environment
    • continuous monitoring
    • clearly defined hygienic zones
  • Established CNN (change control notification) procedures

Download ISO 9001 Certificate

     
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