WESSLING tests pharmaceutical cannabis
Since the amendment of the German Narcotics Act in March 2017, doctors have been allowed to prescribe cannabis blossoms and extract. In future, medicinal products made from cannabis are intended to provide, in certain cases, relief for severely ill people. The law defines strict drug and anaesthetic regulations that must be met before these drugs are allowed to enter the market. WESSLING’s experts have the knowledge and technical equipment to test compliance with the specified quality standards.
Testing by GMP laboratory
In Germany the Federal Institute for Drugs and Medical Devices (BfArM) strictly monitors the import, cultivation, supply and quality of medicines. Currently, this mainly affects importers who import the plant from abroad to Germany under the supervision of the Federal Opium Office. Cannabis grown in Germany, however, is not expected to be available until 2019 at the earliest. In order for the medicinal products to be approved for the European market, a GMP laboratory must have tested the cannabis medicinal product using established methods. At this point, the WESSLING experts support importers of pharmaceutical cannabis with their expertise and carry out tests for the origin, content and purity of the drugs. For this purpose, WESSLING holds the required GMP certificate at the Münster location as well as the BTM approval for testing cannabis blossoms in accordance with the German Pharmacopoeia's (DAB) monograph.
Special challenges in quality determination
There are various different types of cannabis, whose active ingredients, such as Delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD), hold significant differences in content. The quality of the material is therefore assessed by the THC/CBD ratio. The quantitative determination of these substances is of great importance for quality control. WESSLING uses high performance liquid chromatography (HPLC) and suitable reference substances to determine the exact concentrations and constituents of the drug.
Our range of services in the field of quality control of cannabis drugs and hemp products:
Analysis of...
- Identity (macroscopic, microscopic and by means of DC according to EP 2.2.26)
- Contents
- Purity
- Drying loss
- Absence of THC
WESSLING provides the following QP services for cannabis importers and growers:
- Development of GMP-compliant QM systems for companies wishing to apply for an import permit according to Section 72
- Establishment of GMP-compliant QM systems for companies wishing to apply for a manufacturing permit according to Section 13 AMG for the cultivation of medical cannabis
- GMP and GACP consulting, conception of GMP compliant production plants
- Appointment of the Qualified Person (QP) according to Section 13 AMG
- Auditing and qualification of cannabis growers in non-EU countries with regard to the current EU-GMP requirements
Your contact
We will be happy to support you.
- Dr. Maik Siebelmann
- +49 251 13 39 880
- pharma@wessling.de
