Finzelberg achieve positive responses to GMP certification

23/03/05 Finzelberg has reported that more than 100 GMP-Certificates have already been ordered after the company became having become the first European plant-based active agent producer to receive GMP certification.

In 2004, Finzelberg became the first phyto-producer to receive an active agent GMP certification. GMP - Good Manufacturing Practise - stands for consistent quality standards applied to production and control of pharmaceuticals and active agents. With this certificate, customers can now prove that our plant-based active agents are subject to recognized quality standards. The response among internationally active cus-tomers has been strong. 100 copies of the ISO and GMP certificate for Finzelberg’s active agents have already been ordered.

Since 1996, the German producer of plant-based pharmaceuticals has had a quality management system in place, which is certified according to the ISO-9001 standard and for many years has had an official production permit for pharmaceuticals. In for-eign countries, however, the German permit is relatively unknown.

In contrast to pharmaceuticals, for which GMP regulations have long existed, con-crete standards for the production and control of active agents are relatively new. They can be found in appendix 18 of the EU-GMP handbook. Outside of the Euro-pean Union, these GMP regulations are known as the internationally accepted  ICH Q7A  standards. The abbreviation ICH stands for the international “harmonizing” con-ference. This organisation, consisting of representatives from government and indus-try from Europe, Japan and the USA, establishes consistent quality standards, which are recognized in all three regions.