The high production quality of our plants was confirmed after a demanding audit procedure on 8.9.2022 with the new quality seal for hemp producers who work certified according to the GACP quality standards. The GACP label stands for "Good Agricultural and Collection Practice", i.e. good practice for the collection and cultivation of medicinal plants. Sainfort has thus created a major prerequisite for being allowed to produce hemp-based active pharmaceutical ingredients and medicines.
In both Switzerland and Germany, this requires a pharmaceutical manufacturing license (establishment license) from the competent therapeutic products control authority. In Switzerland, the national therapeutic products institute "Swissmedic" is responsible, which delegates supervision to four regional therapeutic products inspectorates. The cantonal health authorities have joined forces in these inspectorates.
For herbal medicinal products, the collection or cultivation of plant material is the first step in the manufacture of medicinal products. The EMA (European Medicines Agency) GACP guideline bridges the gap between field, greenhouse or indoor activities and industrial processing into medicinal products, which is carried out in accordance with the principles of GMP guidelines, or good manufacturing practice.
The GACP certification covers 3 scopes for cannabis:
Table 1: Applicability of GACP, GMP and GDP in the production of medicinal hemp and in the pilot trial with cannabis for recreational purposes in Switzerland.
"The new SWISO-GACP certification closes a previously glaring gap in the cannabis industry and will make a very important contribution to creating uniform quality standards for hemp products for medical use. It is an excellent addition to the canon of quality standards for the non-medical use of hemp products," says Quality Manager Fabian von Kaenel, who has already established a nationally recognized seal of quality for hemp products for recreational and cosmetic purposes with the Swiss Certified Cannabis (SCC) label of IG Hemp.