What would be the best implementation or improvement Trescal would recommend for a medical Cannabis facility?
The adoption of a proper GACP/GMP/GDP compliant Quality Management System (depending on the targeted activity, cultivation, harvesting, cutting, processing, conditioning, storage, distribution) is a key point for the success of our Medical Cannabis project.
To guarantee the adequate quality of our product in a reproducible and consistent way, ensuring its proper manufacture and distribution, it is important that our Quality Management System is also aligned with the guidelines of ICH Q9 (R1) on Quality Risk Management, and complies with the provisions of ICH Q10 on Pharmaceutical Quality System. Process monitoring, CAPA’s management system, change management, and review management must be key elements.
If we are not expert in the requirements that our quality management system has to meet, we will not have the right organisational and technical controls in place, and we could have unforeseen deviations and complaints.
For all of the above, having an adequate Quality Management System is the point that we recommend to review for implementation or improvement.
Mar Díaz, Technical Validation Manager at Trescal