Companies are often faced with problems when looking for the right resources to understand and implement the many instructions and requirements, which follow the production of medicine. Hence, the market experiences massive requests for consultants who can interpret the legislation and convey this to tangible activities and solutions.
Read for production in 9 months
Throughout 2020, Eltronic A/S has supported a large German customer from the design of the plant to successful audits and authorizations from the Danish Medicines Agency (DMA). The German customer has established a medicinal cannabis factory on Fyn in Denmark and has in one year, increased the number of employees from 5 to 35 and up to 70 season workers when the hemp plants are being harvested in the large greenhouses.
In only 9 months, Eltronic A/S had a crucial role in securing that the customer archived; an established and secure Quality Management System (QMS), validated and qualified the quality, and last but not least gained audits and authorizations from the DMA to produce, release and export medicinal cannabis.
Simultaneous development and roll-out
The first step, in Eltronic A/S’s involvement, was to get the company’s Quality Management System (QMS) implemented. However, while this activity was ongoing the factory was also being built. For this process, we provided the customer with input to design updates regarding the fabric’s facility flow – in which room you do what activities. This is very important since the factory needs to be authorized and qualified in all areas. One of the modification suggestions from Eltronic A/S was to change the flow of gowning, which needs to be done in a certain order and way to be approved.
Concurrently with the QMS being implemented across the company and its activities, Eltronic A/S ensured preparation, facilitation, and quality of equipment as well as developing a complete training platform. The training platform guaranteed qualification and education of employees. Another important task was to support the application process for the different and ongoing company authorizations and registrations.
Eltronic A/S had an employee working within the customer’s organization, which enabled us to support the customer in choosing the right consultants and competences to help with the projects. This ensured that the projects were all running very smoothly and met deadlines.
Evete Mawlad, Senior GMP Compliance Lead, Eltronic A/S
GMP, GACP & GDP
It can be quite a challenge to navigate the authorities’ requirements. However, Eltronic A/S has great experience with translating these to specific actions and solutions. We have very skilled employees who work pragmatic, dynamic and listen to our customers’ needs to ensure the achievement of the authorizations in the best and fastest way possible.
Furthermore, we have worked with all processes within the production of medicinal cannabis: Farming, manufacturing, and export, and we work according to Good Agriculture Collection Practice (GACP) and Good Manufacturing Practice (GMP).
Do not hesitate to contact Evete Mawlad, Senior GMP Compliance Lead, if you want to know more or have questions about how we can help your production.
Eltronic A/S Competences