The international markets are moving towards a more liberal legalization of cannabis and EU-GMP certification in Canada is more important than ever. Currently the EU has the strictest cannabis GMP standards in the world alongside Australia. Therefore, having the EU-GMP certification means you will be able to distribute your cannabis products worldwide.
It should be noted this is pharmaceutical grade GMP, which is different than food or natural health care product GMPs, so make sure you have experienced pharmaceutical professional manage this process, like the people at CanWis.
Other countries are joining the movement as well, starting with decriminalization, then allowing for medical use, and finally the recreational use of cannabis.
EU-GMP Certification will require the following:
Site Master Plan
A Site Master Plan is one of the first documents to complete. It’s a high-level plan that includes a thorough thought process using risk management tools like scientific studies, GMP training and quality assurance to name a few.
Pharmaceutical Quality System
This is an integrated approach to all quality programs. The major focus is on control of your starting material through supplier qualification, the monitoring all materials at the critical manufacturing points to facilitate continual improvement of product quality. The strategy should provide documented, transparent and reproducible methods to accomplish high quality product.
Suppliers will be qualified by collecting and reviewing available specification sheets and any applicable certifications, followed by a Quality Technical Agreement and a random testing program. CanWis can ensure a final written assessment and approval of any third-party supplier is complete as per EU-GMP.
A stability program provides evidence on how the quality of different cannabis strains varies with time under the influence of a variety of environmental factors such as temperature, humidity, and light. Testing at defined time intervals will evaluate change in physical, chemical, and microbiological attributes.
Temperature and humidity are critical control points during the supply chain, especially during storage and transportation. There should be documented proof using a scientific study in the form of protocols and reports to demonstrate the temperature and humidity profiles during storage and transportation do not adversely affect finished product quality.
Equipment Qualification & Process Validation
All equipment should undergo a Design Qualification at minimum. Automated pieces of equipment should also be qualified by an Installation Qualification, Operational Qualification and Performance Qualification program. If many pieces of equipment are required to manufacturing the final product, then process validation will be required.
Cleaning Verification / Validation
This program includes taking swabs and rinse samples from manufacturing equipment to ensure there is no cross contamination between the cleaning agents and the cannabis. Since only cannabis will be manufactured on-site, cross contamination from other active ingredients is not an issue unlike the pharmaceutical industry. This program will focus on removing cleaning agents from the surface of equipment after cleaning.