Quality and safety are of great importance to us at KitoZyme. By anticipating and valuing our management, we want to not only respond the requirements of our customers effectively, but also to exceed 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 in our safety management.
KitoZyme delivers high-quality products by following the requirements of:
ISO 9001:2008
- Certificated by Veritas on march 2010
ISO 13485:2003
- Certificated by Veritas on april 2011
- KitoZyme has implemented a quality system in accordance with the standards 13485
- The QMS meets the applicable requirements stated in the Medical Devices Directive 93/42/EEC in order to obtain the notification
Food Safety
- Our auto-control system (SAC) is certified by the Belgian authorities -Agence Federale pour la Sécurité de la Chaîne Alimentaire AFSCA- since november 2009 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
GMP Guide For Cosmetic Ingredients / ISO 22716
- KitoZyme will comply with the GMPs for cosmetic ingredients in June 2012
- KitoZyme follows the ISO 22716 Guidelines on Good Manufacturing Practices
cGMP – The pharmaceutical-grade quality system
- 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”