from von Rainer Krüger und Dr. Lisann Eßer, J&K Consulting
High demand and supposedly large profits are bringing more and more manufacturers of cannabis medicines onto the market. But can the products on offer provide the required quality? Since cannabis is to be sold in Germany as a pharmaceutical product, its production is regulated by the German Medicines Act and the Good Manufacturing Practice (GMP) guidelines. The guidelines aim to ensure the production of pharmaceutical products of consistent and high quality. However, product recalls in Canada are showing increased issues with microbial contamination, which can pose a health risk to patients. Such recalls prove how difficult it is to ensure the required quality of herbal pharmaceutical products, such as medicinal cannabis. This article describes the specifications for the cultivation of cannabis set by GMP and GACP guidelines as well as the quality controls imposed by the pharmacopeial monographs. It will be explained how the quality of the plant can be improved during cultivation and whether the current specifications of the monographs are sufficient to evaluate the quality of the products.