Quality & Certifications

KitoZyme at the heart of health

Quality and safety are of great importance at KitoZyme. By anticipating and valuing our management, we want not only to effectively respond the customer's requirements, but also go beyond them in term of value and certifications. In this context, we have implemented an integrated Management System for the continuous progress of our products.

We believe that nothing can be achieved without continual improvement. KitoZyme is committed to a process of continuous performance improvement

KitoZyme delivers high-quality products by following the requirements of:


  • Certificated by Veritas

  • Certificated by Veritas
  • KitoZyme has implemented a quality system in accordance with the standards 13485
  • The Quality Management System meets the applicable requirements stated in the Medical Devices Directive 93/42/EEC in order to obtain the notification

  • Our auto-control system (SAC) is certified by the Belgian authorities -Federal Agency for the Safety of the Food Chain - FASFC- for the production of nutraceutical and beverage ingredients
  • KitoZyme has implemented the HACCP system (Hazard Analysis and Critical Control Point)
  • KitoZyme is ISO 22000 compliant and provides assurance about:
    • Quality
    • Safety
    • Reliability

  • KitoZyme will comply with the GMPs for cosmetic ingredients in June 2012
  • KitoZyme follows the ISO 22716 Guidelines on Good Manufacturing Practices

  • The pharmaceutical-grade chitosane is manufactured in a fully-dedicated production plant (ISO7-ISO8) in accordance with guidelines:
    • GMP for medicinal products for human and veterinary (Vol 4-Part II of the Eudralex), following the Directive 2003/94/EC of 8 October 2003
    • ICHQ7
    • IPEC-PQG “GMP guidelines for Pharmaceutical Excipients”