Benefits of Pharmaceutical-Grade Cannabis

There’s been significant discussion about the quality of producers in Canada’s medical cannabis program. Michael Kani, a practising pharmacist in Saskatchewan, clarifies the different manufacturing rigours and why GMP is critical for pharmaceutical-grade cannabis.

GPP are Health Canada’s standards.
Under Health Canada’s Access to Cannabis for Medical Purposes Regulations, licensed producers must follow Good Production Practices (GPP), which define the operation of the manufacturing process. Products must have a label claim listing the percentage of THC and CBD, but these specifications don’t have to be consistent lot by lot. Product “A” today could contain a different percentage from product “A” next month.

GMP exceeds federal requirements.
Good Manufacturing Practices (GMP) go beyond GPP. These are the strict standards required for pharmaceutical drugs in Canada.

Quality assurance means consistency.
“The biggest part of GMP is quality assurance,” says Michael. “It ensures that there’s consistency from dose to dose or from batch to batch for that particular pharmaceutical drug.” Product “A” is identical every time—the patient gets the same percentage of THC and CBD and can expect similar results when they use it.

Patient safety is number 1.
Like most plant crops, cannabis could be contaminated by mould, bacteria, heavy metals or pesticides. GMP is designed to minimize contamination risks. “With dispensaries or places that don’t follow GMP regulations, there’s no way of telling how much pesticide they’re using, how much is left in the product once the growth is done and the effect it’ll have on you,” Michael explains. For patients who suffer from serious illnesses that impact their immune systems, the health risks of consuming contaminated cannabis can be potentially fatal.

Pharmaceutical packaging provides protection.
GMP protocols require child-resistant, tamper-evident, airtight containers that protect from moisture and the growth of micro-organisms. Michael stresses, “Packaging should make it look like medication—not candy.”

Testing means trust.
While GPP requires only end-product testing, GMP requires quality testing at every production phase. The soil and water are tested for impurities. After the harvest, the cannabis is tested for metals, microorganisms and mycotoxins to ensure it’s free of E. coli and salmonella and that yeast and mould are below food-safe levels. The recall chance is very slim because testing would detect contamination before the product hit the market.

Beware of GMP certification claims.
In Canada, there’s no GMP certification—there’s only compliance with the Food and Drugs Act and its associated regulations. CanniMed is the only licensed producer deemed by Health Canada to be compliant with the Act and its regulations. Products that don’t meet their rigorous GMP standards, including 281 points of quality control, aren’t released. The result is a standardized, trusted supply of pharmaceutical-grade cannabis.

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