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Case Study - Greifswald University Medicine relies on ELPRO for qualification of devices and processes for production authorization.
Case study about how Aurora Produktion obtained production authorization for medicinal cannabis in Germany with GMP-compliant environmental monitoring from ELPRO.
Aurora Produktion, a subsidiary of the Canadian cannabis producer Aurora Cannabis Inc., has been producing medicinal cannabis for the German market at its site in Leuna since May 2022.
In 2017, medicinal cannabis was legalized in Germany. The law governs the use of cannabis medicines as a therapeutic alternative for serious illnesses and in palliative care. 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.
A key aspect of setting up the production facility at the biochemistry park in Leuna, Germany, was the implementation of a GMP-compliant monitoring system. This was necessary in order to pass the GMP inspection and obtain the production license. In ongoing production, it was to ensure product quality and protection as well as optimize the processing operations.
In this case study, you will learn how Aurora Produktion
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successfully validated and commissioned a GMP-compliant environmental monitoring system;
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successfully passed a GMP inspection, subsequently obtained a production license for medicinal cannabis in Germany; and
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successfully started production of medicinal cannabis for the German market in May 2022.