Courtesy of Triskele Quality Solutions
Despite the rapid evolution of the cannabis industry, the assurance of safe manufacturing practices remains unclear. The lack of federal oversight and inconsistent guidance on manufacturing, packaging and labeling, and testing of cannabis products offers the potential for unsubstantiated, non-scientific, and often times blatantly false claims on product safety and efficacy.
Enter a business whose goal is helping organizations navigate the new world of legal (or soon to be legal) cannabis and hemp products, Triskele Quality Solutions. Founder and CEO, Kathleen May, located in Grayslake, IL, travels nationwide and assists clients in both the marijuana and hemp markets.
“I attended my first cannabis conference in California in 2016,” May recalls. “After a day of walking the event and talking to equipment vendors, product manufacturers and testing laboratories, it was abundantly clear that the concept of quality and the assurance of consumer health and safety wasn’t addressed anywhere in their business model or company objectives. The need was immediate and long overdue. Medical cannabis has been legal in California since 1996, but testing requirements were not finalized until 2018!”
Courtesy of Triskele Quality Solutions
Across the country, the emerging industry faces unique challenges. The FDA has not yet mandated the implementation of Good Manufacturing Practices (GMPs), but rest assured those regulations are coming. GMPs are a system for ensuring that products are consistently manufactured and controlled according to quality standards and regulatory guidelines. A compliant GMP program ensures consumer health and safety, defines product intended use, defends product specifications, and minimizes overall business risk. GMP defines the responsibilities of manufacturers to ensure safe distribution of consumer goods.
“Attempting to back in to a GMP or GLP compliant operation once up and running will take a great deal of time, money and resources that companies may not be willing to invest in since the focus shifts to making a profit to recoup startup costs,” May explains.
Courtesy of Triskele Quality Solutions
Budgeting for and implementing best practices in the planning and design phase “will prevent the need to remediate processes and procedures when the laws change, as well as minimize operation down time and potential lost revenue while working on updates to any impacted processes and procedures,” she continues. “Implementing safe and compliant practices from the beginning doesn’t just ensure consumer health and safety, it protects a company’s bottom line.”
May realizes that one size does not fit all when it comes to cannabis. “When I engage with a client, I gather an understanding of the intended use of their products and recommend the appropriate regulations and guidance based on that. Initially those recommendations are based on FDA rules and regulations, but if they are looking to market in other countries, such as in Europe, then we review the guidance and regulations mandated in those countries.”
Triskele will conduct a gap assessment to determine any GMP deficiencies, develop an action plan to address any identified deficiencies, and schedule a mock GMP inspection prior to your third party GMP audit. Triskele Quality Solutions is a unique one-stop for cultivators and manufacturers of cannabis and hemp products.
