The New and Improved QAP
The Proposed Regulations Amending the Cannabis Regulations have certainly provided a stir and the assessment for Proposed QAP requirements is just another on the list of items for licence holders to consider.
The Quality Assurance Person (QAP) is the heart of any site – they’re the people who release the product, manage the QMS and answer to Health Canada. In these new proposed regulations, your QAP and their responsibilities in plant, are going to be scrutinized even more, so it’s best to be aware of the proposed requirements and ensure your QAP is up to date.
Depending on your product types, your QAP may need more qualifications and in all cases, will have more authorities and responsibilities. Section 19(1) has been added to the proposed regulations to state that the QAP requires adequate training, experience and technical knowledge related to both GPP and the activities related to the product class under the licence. This means if you are making edibles, you are going to need an individual with food safety / Preventive Control Plan (PCP) methodology, likewise, if you are making extracts similar technical knowledge will be required.
These additional requirements are going to be a tremendous challenge for an industry that is already suffering from lack of qualified individuals. Finding a QAP with technical knowledge related to the product classes will be paramount to continuing operations for licence holders. If your QAP doesn’t have this background, there is a provision that allows you to obtain the service of another individual. This may be interpreted to mean another (non-QAP) individual in the QA department and/or consulting services in order to ensure food safety principles and/or extraction knowledge are properly engrained in the Quality Management System.
Another indicator of the increasing responsibility on the QA are the additions in Section 88 which outline several QA requirements including: investigations to be conducted by the QAP, including taking measures to mitigate any risk after such investigations, procedures for cannabis and ingredients to be approved by the QAP, QAP to approve PCP’s for cannabis extracts and edible cannabis, and batch approval. A lot of these are in practice at most licenced holders, however they are now explicitly required in the regulations. As well, there is going to be more onus on an understanding of testing methodology as testing methods will have to be approved by the QAP. In practice, the QC function is often outsourced and less understood than the inner workings of the QA operation since most QA’s haven’t had analytical laboratory experience.
It will be imperative that to invest the time necessary to ensure your corporate plans and product portfolio align with your QA department, including internal alignment and skill upgrades where needed.
Your QAP’s time is so valuable it will be important to choose the right training program that delivers key materials in the most efficient time possible. Cannabis Compliance Inc has Training & Recruitment Programs and Services to help you with your QAP plans and more. Contact our subject matter experts today. Karina Lahnakoski – Vice President, Pharmaceutical Cannabis Services Email: email@example.com