Our quality management system is based on the German Drug Law [AMG], the German Ordinance on the Production of Pharmaceuticals and Active Substances [AMWHV], the Ordinance on Trade with Medicinal Products [AM-HandelsV], the EU GMP guidelines and the EU GDP guidelines in their current valid versions.
All of our work processes are SOP-controlled, our installations and equipment are qualified and our inventory control system is validated.
All of the relevant functions under pharmaceutical law are competently filled and competent stand-in arrangements are in place.
- Qualified person / competent person
- Quality assurance
- Quality control
- Person responsible for narcotics
- Information Officer
- QPPV - Qualified Person Pharmacovigilance
- Head of Production
The Executive Board is actively involved in quality management.