Don’t Let THIS Blow Up In Your Face
For all the manufacturers in the cannabis industry – you’ve seen this rush before, so buckle your seat belt, because here we go again. Every company wants their new class products (extracts, edibles, and topicals) to be the first on store shelves by the end of this year. But, are you sacrificing quality in order to gain speed? It’s no secret that vapes (and their major concerns around consumer safety) are in the hot seat. The pressure is on for manufacturers to deliver a safe and reliable product in anticipation of December 2019, when sales in Canada will commence.
Before we dive a little deeper into the specifics around vape development practices needed for ensuring the safety of end-users, ask yourself these three simple questions:
- Am I confident that my product is defect-proof? Especially the cartridge.
- Are input materials quality-controlled at all aspects of the production cycle?
- Am I producing my product in a sanitary manner?
If you answered “no” or are unsure of the answer to one or more of those questions, then continue reading.
While seen as a simple product (“it’s just resin”), the mechanics, development specifications, and method of administration (inhaled into the lungs) of vapes create complexities that need to be addressed. Here are three areas of risk that developers should consider when producing vape products:
- Safety. Defects (often seen with cartridges) usually reveal themselves when in use on a larger scale. Through tightly controlled vendor audits, quality management systems (ISO system) and proper studies, developers of vape products can ensure that their delivery mechanism is safe and maintains the purity and quality of the product it contains.
- Product development. Input materials need to have critical quality attributes defined in order to achieve the end-product specifications. Cannabis vape product developers should be looking to confirm if the pesticide applications, quality of the flowers used (e.g. microbiological specifications), and oils will have any impact on the final product.
- Cleaning validation. Although cleaning validation is not a requirement under the Cannabis Regulations in Canada, it is a requirement that the product be produced in a sanitary manner. This would include ensuring that residuals of previous batches are removed, that any cleaning agent does not transfer into the next batch of product, and that the sampling methods employed are suitable to detect potential contamination events.
The potential for risk is apparent – however, with the correct preventative measures in place, most if not all that risk can be mitigated. How you ask?
- Implement a robust PCP (Preventative Control Plan) – A PCP not only identifies risks in the product/manufacturing process, but reviews, categorizes, ranks, and specifies control measures for key hazards.
- Utilize a comprehensive complaint system – one which can detect and address potential issues related to gaps in development.
It’s no secret, everyone wants to gain the first-mover advantage in a short amount of time; but companies cannot lose sight of ensuring that their products are developed and delivered with a quality-focused program top of mind. It is the sole responsibility of the manufacturers to ensure that consumers are safe and not put at risk through use of their products. Remember, even the smallest of errors can be detrimental to consumers and your business.
Written by: Karina Lahnakoski, Vice President Quality and Regulatory, Cannabis Compliance Inc.