quality management

Quality Management

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.