Systems

We have implemented a quality system in compliance with ISO 9001:2000 and Good Manufacturing Practices Guide for Bulk Pharmaceutical Excipients (IPEC).

Additionally, the quality system is based on the Guidelines for Good Manufacturing Practice for Active Pharmaceutical Ingredients (ICH Q7).

This quality system applies to all manufacturing sites of DMV-Fonterra Excipients in Foxhol, The Netherlands and Nörten-Hardenberg, Germany as well as to those of our manufacturers DMV International B.V., Veghel, The Netherlands and Fonterra Limited, Kaponga, New Zealand.

All mentioned sites are ISO 9001:2000 certified.

Manufacturing of excipients is not supervised by any regulatory body supplying an official GMP certificate.

DFE’s Quality Assurance program ensures that the implemented quality system is maintained on the GMP-level for Bulk Pharmaceutical Excipients. All regulatory changes are evaluated and implemented when deemed necessary.