The European Pharmacopoeia recently published a unified monograph for cannabis flowers, setting clear standards for the quality and content of active ingredients. This monograph will form the basis for quality assurance of medical cannabis in Europe.
The new European Pharmacopoeia guidelines define clear parameters for the production and testing of cannabis flowers. This ensures that patients have access to safe and high quality products.
Dr. Johannes Junemann, Head of Quality Control at Quality Services International GmbH , expressed his delight at this development: “The introduction of this uniform monograph is an important step for the standardization of medical cannabis production in Europe. It ensures patients have access to safe and high quality products.”
Quality Services International GmbH , the leading company in the field of medical cannabis quality control, has announced that it will work immediately on implementing the new monograph. The implementation will be completed well in advance of the entry into force on July 1, 2024. Dr. Junemann emphasized the importance of this step: “Our experts are working closely with manufacturers to ensure that they meet the requirements of the new monograph and make the transition as simple as possible for everyone involved in order to ensure patient care.”
The new monograph contains detailed requirements for the quality, content of active ingredients and purity of cannabis flowers. The significant changes compared to the cannabis flower monograph in the German Pharmacopoeia include:
• When testing for foreign components, there must be no seeds in the flowers to ensure the purity of the product
• Increasing the drying loss from a maximum of 10 to 12 percent in order to better take into account the natural fluctuations in the moisture of the flowers.
• Adding heavy metal limits to ensure medical cannabis is free of harmful contaminants.
• Significant changes in the content determination for the analysis of cannabinoids in order to enable a more comparable and reliable determination of the active ingredient concentration.
For further information about the new monograph and implementation at Quality Services International GmbH, please contact:
Dr. Johannes Junemann
Head of Quality Control
Quality Services International GmbH