The North American College of Pharmaceutical Technology (NACPT) is conducting a pilot series of professionals in medical cannabis workshops, and we spent a day learning and discussing food safety, regulatory tech, processes and systems. NACPT CEO and Founder Rathi Param brings a multi-disciplinary lens to the cannabis industry having worked as a validation scientist and quality control consultant across food science, biopharma, agro-tech, the environment, medical devices and more industries.
Consumers want quality and they want to be safe. Especially cannabis users who are way more likely to perceive cannabis as safer than tobacco but also alcohol according to Canada’s largest syndicated survey of cannabis consumers Vividata. (The overall population including users and non-users of cannabis, generally perceive cannabis as more socially acceptable than tobacco but less socially acceptable than alcohol according to the same study). In an environment with restricted regulations on marketing cannabis, it is critical to learn that product quality is the top influencer in customer purchase followed by form (e.g. bud/pre-roll/vapes/ etc.). There are currently 2.6 million edibles users in Canada, making it the second most popular form of consumption after flower, according to Vividata.
Thus, it was appropriate to attend the NACPT workshop all about how to push quality product to market and into the consumers’ hands. Validation is about achieving standardization in processes to demonstrate consistency, an important aspect of preventive control plans. The five quality control aspects of Good Manufacturing Practices (GMP) include: strength and purity, consistency, safety, integrity and quality. A good preventive control plan for edibles involves process mapping (or flowcharting), hazard analysis plans (how to analyze and respond to hazards), and understanding the various critical points to consider.
An edible preventive control plan is a set of written documents based on food safety principles incorporating hazard analysis, threat and vulnerability assessments, preventive controls, supply-chain programs, a product recall plan (companies have a complaint procedure to recall a product from the market; a solid tracking system is key). A PCP outlines the procedures to be followed for monitoring, corrective actions, and verification. This relies on a solid understanding of critical control points, or steps in a food process where control is applied to prevent or eliminate a food safety hazard (example: biological, chemical or physical contamination). Sometimes, cross-contamination occurs beyond reasons of control and you can only pray overnight nothing bad gets in the facility or food, shared Param.
Questions to ask throughout the monitoring process could include: Are employees in direct contact with the product? Is the temperature and humidity control right for product safety? Could food safety hazards be introduced from equipment, personnel or the environment? Is there historical, prospective and current data to be mined? (in terms of self-inspections or audits or otherwise), etc.
Drawing from the highest standards of HAACP, SFCR, FSMA, and GFSI, preventive control planning involves throwing parameters and checking quality. If the quality of a cannabis product is not to spec, the parameters need to be rechecked. If you do the validation testing properly, your product will not fail. Ongoing monitoring and control testing will ensure a product’s safety. The processes outlined in maintaining cannabis quality standards throughout the supply chain are also very similar to Six Sigma standards in project management.