The ‘Risk’ in the Proposed Regulations
GPP (Good Production Practices) are getting a make over the in Proposed Regulations Amending the Cannabis Regulations. Many might think the main change in the regulations is about the allowance for edibles and extracts. However, when you dig deeper and do a side-by side comparison of the amended sections of the regulations, it’s clear that GPP is going to be kicked up a notch, and it will affect all licence holders – both cultivators, and processors.
Health Canada has already given a summary of the proposed GPP changes in their document, so those won’t be rehashed. However, the one major theme in the GPP changes appears to be one of RISK. The word “risk” is entirely absent from Part 5 (GPP) of the existing regulations, yet in the proposed regulations the word is mentioned numerous times. And not all the risk requirements are in association with the widely known new requirement to have a Preventive Control Plan (PCP) for the product.
Take the following proposed additions to the regulations:
- 88 (b) A holder of a licence for processing must ensure that if necessary, following an investigation, the quality assurance person immediately takes measures to mitigate any risk.
- 88.4 A holder of a licence for processing must ensure that physical or other effective means are used to separate cannabis or anything that will be used as an ingredient from anything that presents a risk of contamination of the cannabis or the thing that will be used as an ingredient.
- 88.8 If any land that forms part of a site set out in a licence for processing, or any land that is located near such a site, presents a risk of contamination of cannabis or anything that will be used as an ingredient, the holder of the licence must take measures to eliminate the risk.
- 88.93 (1) A holder of a licence for processing that produces a cannabis extract or edible cannabis must identify and analyze the biological, chemical and physical hazards that present a risk of contamination of the cannabis or anything that will be used as an ingredient in the production of the cannabis extract or edible cannabis.
Holistically these updates mean that a licence holder must have an excellent understanding of their site, material, process, equipment and personnel flow and documentation to present to an inspector. For current operations, now is the time to consider a Risk Management Program for your Quality Management System.
One way to do this is to implement a Risk Assessment SOP, following ICH Q9 “Quality Risk Management”. Risk Management for the site, goes beyond the requirement for the product, and into using quality risk management principles on a regular basis to assess risk, mitigate it, and be able to present this to an inspector as practical evidence into how you are meeting the above requirements.
Whether or not all these proposed changes make the ‘final cut’ of the regulations, it is clear the risk oversight is here to stay and all sites should be taking actions to implement risk management with a proper plan.
Cannabis Compliance Inc. has experience working with licence holders on developing a Risk Management Program and implementing it for everyday use. We can also assist in executing the written Risk Management Program for deviation investigations and CAPA programs.
Written By Karina Lahnakoski