In 2019, three companies received an order from the German Federal Institute for Drugs and Medical Devices (BfArM) concerning the production of a total of 2.6 tons of medicinal cannabis per year in Germany for the German market. One of them was Aurora Produktion.

Aurora Produktion is implementing a GMP-compliant monitoring system during construction of its production facility in Leuna, Germany. This is necessary in order to pass the GMP inspection and obtain the production license. In ongoing production, the monitoring system ensures product quality and protection, and it optimizes the processing operations.

In this case study, you will learn how Aurora Produktion

• successfully validated and commissioned a GMP-compliant environmental monitoring system;

• successfully passed a GMP inspection, subsequently obtained a production license for medicinal cannabis in Germany; and

• successfully started production of medicinal cannabis for the German market in May 2022.