Allgemein

Cultivation of medicinal cannabis under GACP and GMP –
What is the difference?

We are talking to cultivators and other organizations in the field of medicinal cannabis for more than two years. Especially in the last year, we recognized that the topics GACP and GMP are understood as minor criteria for the cultivation of medicinal cannabis. As of this reason medicinal cannabis projects are drawn up wrong in the conception design phase already.

Next, it appears that the suppliers of needed equipment are not checked critically. The purchaser relies on the marketing material, which says that the delivered equipment is already GMP-ready. A supplier audit being a standard in the pharmaceutical industry does not take place. Accompanying this circumstance is the fact that no requirements are created, challenging a product through a risk based approach. The trust in the supplier’s goodwill bears a high risk for an unprofitable investment. Thus, the implementation according to this approach will not stand the authority’s requirements in the long term. In addition, corrective actions are expensive, if possible at all.
We very often point out these problems in an initial meeting and are thereby able to get the focus on the required GACP and GMP topics to further push the project. For this purpose we are able to rely on >25 years of experience in the pharmaceutical industry.
In detail, for a GACP and GMP project, relevant steps and processes need to be gathered for structuring and content control with regard to quality, integrity, scope and topicality in a first step. In a second step, processes and an organization have to be established, which implements the defined requirements and all steps according to GMP compliance. All process steps need to be tested against the requirements. In addition, it has to be ensured that the processes are well established and lead to the expected result. Reproducibility according to the requirements is the key to success.
Most mistakes are made in this early, theoretical phase as projects have no GMP-basis. Thus, international reality shows that a lot of investments are in the planning or implementation period already. Due to the fact that no GMP-compliant processes are established, no critical failures become identified. Moreover, investors hope for suppliers to solve the GMP-topic with their knowledge in advance.
Based on this hope and the trust into the suppliers the accruing processes seem to be feasible, but won’t stand a first simple GMP-audit. As we stood inside production facilities that were built to be set productive in 6 months, we have to find solutions to rescue the projects and linked investment costs.
To avoid a project stop, all processes have to be synchronized and the next legal actions taken, as well as the change pushed in parallel. We, from J&K, have intensively looked at this situation and developed methods of solution within the last 24 months.
These led to an extensive 3-ary medicinal cannabis audit management system:

  • J&K Quick GACP and GMP Audit
  • J&K Short GACP and GMP Audit
  • J&K Detailed GACP and GMP Audit

In addition, we take a look at the identified deviations and develop, together with our customers, specifications and whitepaper for the fields:

  • Product

  • Production process

  • Facility

to establish GACP and GMP compliant processes.


Furthermore, we are a founder member of the German-Canadian-Cannabis Network, which is dealing with the topic cannabis from a scientific point of view. In parallel we established the European Cannabis Association with specialized companies to provide a network of companies with the necessary knowhow and real experience.


Feel free to contact us if you have any questions or comments regarding this topic.

Autor:
Rainer Krüger

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