Pharmaceutical cannabis: consulting and analysis

Our pharmaceutical experts support companies that want to grow pharmaceutical cannabis in Germany or import its flowers and oils.

GMP-certified laboratory location Münster, narcotics licence according to Section 3 of the German Narcotics Act

At our GMP-certified laboratoy location in Münster, 70 experienced employees work with consulting, audits and analyses for the quality and safety of your cannabis medicinal products and hemp products. These services are carried out in our GMP-certified laboratory at our Münster location. This is because the testing with validated methods of medicinal cannabis flowers, oils, or other pharmaceutical dosage forms, in a GMP laboratory, is one of the prerequisites for authorisation in the European market. WESSLING has the required narcotics licence according to Section 3 of the German Narcotics Act from the Federal Opium Agency to be allowed to conduct this type of analysis.

 

Analyses according to the German Pharmacopoeia (DAB) in quality control

We perform cannabis quality checks for you by testing cannabis products for identity, content, and purity. This includes testing for contamination by heavy metals or pesticides, and the content of cannabinoids, such as tetrahydrocannabinol, cannabidiol and cannabinol.

Our services in detail:

  • Identity testing: macroscopically (flowers), microscopically and by means of DC (oils) according to EP 2.2.26
  • Content testing of cannabinoid (oils and flowers) for the parameters delta-9-tetrahydrocannabinol (THC), delta-9-tetrahydrocannabinolic acid (THC-A), cannabidiol (CBD), cannabidiolic acid (CBD-A) and cannabinol (CBN)
  • Testing for purity: cannabinol, foreign components, loss on drying (flowers), water content, ethanol as residual solvent (oils), loss on drying, absence of THC
  • Microbiological testing of cannabis flowers, oils and extracts according to Pharm. Eur. 5.1.8 Cat. A, B and C, as well as 5.1.4 and the necessary proficiency tests/validations
  • Testing for aflatoxins, ochratoxin A, pesticides/dithiocarbamates, heavy metals in flowers and oils
  • Preparation of quantitative terpene profiles for cannabis flowers for the following parameters: α-pinene, camphene, β-pinene, myrcene, 3-carene, α-terpinene, p-cymene, limonene, eucalyptol, ocimene (α and β), γ-terpinene, terpinolene, linalool, isopulegol, geraniol, β-caryophyllene, α-humulene, nerolidol (cis- and trans-), caryophyllene oxide, guaiol and α-bisabolol
  • Determination of the density (oils) and uniformity of the drop mass (oils)
  • Analysis of CBD as isolate (pure substance) according to DAC; the analysis includes the parameters: identity: melting temperature, IR spectrum, DC; testing for purity: specific rotation, related substances, sulphated ash; CBD content
  • Stability storage and stability testing of cannabis flowers and oils
  • Testing of alternative forms of preparation, such as baking mixes

Consulting services for cultivators and importers of cannabis

For several years now, we have been advising international clients on the import of medicinal cannabis, both as flowers or as extracts, into the EU and Germany. Therefore, we have extensive experience in conducting the required audits on the plantations and in production and provide GAP analyses to determine the GMP compliance status. Our customers also receive support from our pharmaceutical experts in establishing the required GMP quality management systems.

Our services in detail:

  • Establishment 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 wanting to apply for a manufacturing authorisation according to Section 13 of the German Medicines Act for the cultivation of medicinal cannabis.
  • Maintenance of QM systems and advice, e.g., creation of work instructions
  • GMP and GACP consulting, conception of GMP-compliant production facilities
  • Providing a Qualified Person (QP) according to Section 13 of the German Medicines Act
  • Providing a Responsible Person (GDP)
  • Auditing and qualification of cannabis cultivators in non-EU countries with regard to the current EU GMP requirements

Your contact person

© WESSLING - Maik Siebelmann
„Our services are entirely customised to your needs. With our expertise, we ensure that you can bring your pharmaceutical cannabis to market.“

IFUA is now part of WESSLING

Managing directors of WESSLING GmbH and IFUA Projekt GmbH

WESSLING is expanding with the Bielefeld-based appraisal and expert office IFUA Projekt GmbH.

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