EDQM grants Umicore the world’s first CEP-Certificate of Suitability for zinc oxide
The Umicore plant at Eijsden
Umicore’s facility in the Netherlands is the first plant in the world to have been granted the CEP-certificate for zinc oxide by the European Directorate for the Quality of Medicines and Healthcare (EDQM). This CEP-certificate enables Umicore to guarantee its customers the highest quality zinc oxide for the production of their medicines, veterinary and personal care products.
The Falsified Medicines Directive (EU 2011/62/EC) came into force in 2013 indicating that APIs (Active Pharmaceutical Ingredients) and excipients in pharmaceutical products need to be manufactured in full compliance with Good Manufacturing Practice (GMP). For the first time customers have a GMP-compliant alternative for zinc oxide, which Umicore is selling under the product range Zinc Oxide ‘Pharma-GMP’.
This allows manufacturers to be compliant with the new directive and at the same time facilitates the registration of their products under the EU legislation as the certificate itself grants the necessary approvals.
'This is an important milestone for Umicore’s activities in zinc oxide APIs,' said Koen Demesmaeker, Business Unit manager Zinc Chemicals. 'The CEP-certificate is a recognition of our commitment, sense of responsibility and hard work to continue supplying the pharmaceutical, veterinary and personal care industry with the highest quality zinc oxide.'
Since 2011 Umicore has undertaken further improvements at its Eijsden plant in terms of production processes and quality systems to manufacture zinc oxide in full compliance with the ICH-Q7 GMP guidelines. Umicore’s facility opened in 1870 and offers high quality products and professional services to the highest level of quality assurance and control; 65 people work in the Eijsden plant.