Which aspect of the GMP design of a medical cannabis industry requires the most attention?
I would say the most critical aspect focuses on ensuring strict control of environmental conditions. Maintaining a controlled environment is crucial to ensure product quality, safety and regulatory compliance. Here are some specific areas that require special attention:
- Air treatment: The GMP area must have an efficient HVAC system with high efficiency air filters to remove particulates, dust and contaminants from the air.
- Flow of personnel and materials: The design of an efficient workflow within the GMP area is essential to prevent cross-contamination. Proper separation of materials, equipment and personnel is necessary to avoid the transfer of contaminants between different production stages or product batches.
- Qualification: Validation of cleanroom systems and processes is crucial to ensure their effectiveness. It involves testing and verifying the performance of equipment, air filtration systems and cleaning procedures to confirm compliance with established standards.
- Staff training and hygiene: Staff must understand the importance of following protocols, wearing appropriate attire and maintaining cleanliness to minimise the risk of contamination.
Raúl Fernández, Technical Director at Labsom