Medicinal Cannabis and the GACP/GMP jungle
Medicinal Cannabis can support various treatments in reducing side effects and symptoms, such as nausea and pain. Medicinal Cannabis, however, has to comply to GMP requirements as any medicinal substance or product has. Navigate the requirements together with Avanti Europe.
The restrictions around cannabis
First, we need to distinguish between hemp and cannabis. Hemp is a fiber-rich plant usually listed in the catalogue of varieties of plants and primarily used for its fibers, whereas cannabis is not listed in the catalogue and primarily used for the chemical ingredients produced in the flowers, called buds.
Growing cannabis with a high level of Tetrahydrocannabinol (THC), a psychotropic agent, is prohibited in most countries and levels of THC are non-harmonized. In Switzerland, the path to medicinal cannabis for a patient is the following:
- The patient needs to find a doctor in favor of prescribing medicinal cannabis
- The treating doctor needs to file an exemption certificate to source medicinal cannabis
- The supplier needs to file an exemption certificate to deliver the medicinal cannabis based on the doctor’s request
- The manufacturer needs to file an exemption certificate to plant, grow and harvest based on the doctor’s request.
The requirements for the manufacturer
Only upon a valid exemption certificate issued by the regulating government body, i.e. BAG, the manufacturer is allowed to plant, grow and harvest cannabis with medicinal use. But it is more than just gardening and cultivating the plant. A manufacturer has to follow the Good Agriculture and Collection Practice (GACP), a sub-part of the GMP regulations. GACP takes care of different aspects of a quality management system to provide plant and plant material which suffices the quality understanding of medicinal plants and allows a trace-back to the originating seed or seedling, including any manipulations on the plant during its growth. A comprehensive documentation regarding pre-defined quality aspects of the plant is one of the major parts of a compliant GACP approach.
Storing the plant material
Storing the plant material has not only to be in compliance with the local narcotics law but also with the requirements laid down in the GMP guidance. Restrictive and logged access to the plant material is evenly important as the segregation of final product, intermediates and starting material. Again, logging of all manipulations on the material is vital in regards to the quality and storage of the product.
The difference between GACP and GMP
The manufacturer of the plant should follow the requirements laid down in the GACP guidance. The GACP, however, is part of the GMP and there is no real boundary between the GACP and GMP requirements. For example, the processing of plant material in terms of extraction can belong both to GACP and GMP requirements. This, sometimes, leads to confusing on which quality management system to apply.
How Avanti Europe can help
The Experts of Avanti Europe can support you as medicinal cannabis manufacturer in establishing the processes and quality management structure to be compliant to GACP and GMP guidelines. Compliant processes and a certified quality management system allow the manufacturing of acceptable material for further medicinal use.