We have been getting a lot of questions from patients about our manufacturing and production practices and thought that we would use this forum to explain why, at CanniMed Ltd., we follow Good Manufacturing Practices (GMP) at every stage of our production.
Under Health Canada’s Marihuana for Medical Purposes Regulations (MMPR), Canadian LPs have to follow Good Production Practices (GPP) which clearly structure and define how every stage of the manufacturing process is to operate. There is one specific difference between the two practices that helps demonstrate why we follow GMP:
Good Production Practices (GPP): While products have to have a label claim – i.e. the label needs to list the percentage of THC and CBD – these specifications don’t have to be consistent. This means that Product “A” that a patient receives today could contain a very different THC and CBD value than Product “A” they purchase next month.
Good Manufacturing Practices (GMP): The same label claim is required on GMP products, but in this case Product “A” requirements will be the same each and every time - meaning the patient gets a consistent product.
At CanniMed patient safety is our number one concern.
As you may or may not know, the ‘medicine’ in cannabis forms on the very outside of the female cannabis flower, meaning that it is very susceptible to anything in the environment that surrounds it. The medicinal compounds form in structures on the very outside of the plant called trichomes. Therefore, anything from the air – moulds, sprays, bugs etc. – could find its way on to the plant, compromising its safety. Clean plants produce a safer finished product that can be used with confidence by every CanniMed patient.
Our GMP facility was setup to control for every environmental variable. Growth chambers are secured from the outside environment, and our plants are protected from the elements, including unwanted pests, dust and other crops. We have designed a proprietary soil to propagate the plants, and we use the same nutrients commonly used on vegetables. The water given to the plants is tested regularly for metals and other impurities.
This diligence doesn’t end at harvest. We also test for metals, microbials and mycotoxins to ensure products are free of E. coli and salmonella, and other microorganisms like S. aureus, yeast, and mould are kept well below food-safe levels. There are also strict maximum limits for metals aligned with the Natural and Non-prescription Health Products Directorate.
So why do we go through all of this effort? Many of our patients suffer from serious illnesses that impact their immune system. For these individuals, mould, bacteria, and pesticides that are common in marijuana grown outside a clinical setting can be extremely dangerous. The health risks of consuming mouldy or otherwise contaminated marijuana are very real, and can be fatal.
If a product lot does not meet rigorous standards including 281 points of quality control, it is not released.
At CanniMed, patient safety is our number one concern and that’s why we believe that a GMP guided process is critical for the manufacturing of pharmaceutical-grade cannabis.
This system also allows for CanniMed products to be used in clinical research as the testing standards allow for only a very small amount of variation in delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) concentration. So far the science has pointed to THC and CBD being two of the main factors determining a cannabis product’s efficacy so these ratios need to be consistent for a clinical trial to produce usable results.
GMP is the same standard that all pharmaceutical companies employ when they produce their medicines. Our goal in using this process is to produce medicine for our patients which is both safe and effective.