A challenge whose success lies in efficient process management and digital development! The times of digitalisation and Industry 4.0 do not stop at the production of medical cannabis for the pharmaceutical industry. The combination of IT systems and blockchain-based processes allows the value-added chain to be automated and the data generated to be mapped in a tamper-proof manner.
by Hannah Maria Lambertz, Consultant and Quality Manager at J&K Group
Filling and packaging are just as relevant as components of pharmaceutical production as all preceding process steps in the value-added chain. Therefore, an intensive and effective risk assessment is required to ensure patient safety regarding medical cannabis. This is due to the fact that upstream, finishing processes result in an open pharmaceutical product whose composition can be affected or contaminated by external influences. Furthermore, in the course of the process, the risk of contamination cannot be excluded, even when cannabis products are packaged. The greatest risk to patients is with the immediate packaging, as here, the packaging is in direct contact with the medicinal product, and therefore, the highest risk of exposure to the medicinal product exists. In the case of secondary and tertiary packaging, the greatest risk lies in the unambiguous traceability of batches. Within the value chain, all data that have a quality-relevant influence must be recorded and processed to ensure clear batch traceability.
In order to maintain data integrity, various companies are working on electronic data management systems that, in combination with cloud-based block chain solutions, digitally map parts of or even the entire value chain and store and distribute relevant information in a tamper-proof manner.
While manual work steps related to the product, like packaging, are still the order of the day, in many places in the medical cannabis industry, the pharmaceutical industry is currently rethinking this process. Since patient safety is the top priority in the production of drugs, switching to fully-automated systems at this point will greatly increase patient safety.
Since a digital solution is available for almost every procedure step, GMP processes must be designed in accordance with the latest state of the art in science and technology, because only the continuous development of processes can keep up with the global market. Furthermore, it is recommended that all manufacturing processes are based on digital concepts, the projects are planned and implemented digitally, and the production is managed digitally.
In this way, all process-relevant information can be stored and utilized in a single, digital solution in a tamper-proof manner, so that in this system, from sowing to growing, processing, packaging, and storage to distribution, all data can be made available remotely for the various stakeholders. A cannabis agency, for example, can retrieve the quantity reports from the cloud, instead of these having to be reported by the company, as was previously the case, offering a whole new level of data integrity. This is essential in order to be able to implement upcoming, regulatory requirements in a timely and cost-effective manner and, thus, to be able to survive in the constantly growing market.
The article was published in the European Biotechnology Magazine Spring Edition 2020.
Photo: Gerd Altmann / Pixabay