Budding Quality in Budding Industry
by Lindsay Bowman, Quality & Regulatory Consultant
Prior to 2013, the requirement for “Quality Assurance” for medical marihuana did not exist. To be honest, when I told friends and family that my job title was Quality Assurance Person (QAP) for medical marihuana, they thought I was making a joke. Yet 5 years later I can reflect back and see how far we have come.
I began working in the cannabis industry as a QAP for a Licensed Producer (LP) in Canada that received their cultivation licence in 2013. At this time, the regulations governing us were the Marihuana for Medical Purposes Regulations (MMPR), now the Access to Cannabis for Medical Purposes Regulations (ACMPR). For large scale medical marihuana production, the MMPR first introduced Quality Assurance (QA) requirements, and the ACMPR built on those quality standards. The regulations were, and still are, a blend of the Narcotics Control Regulations, Natural Health Product Regulations, and the Food and Drug Regulations. All of this for a crop that is classified as a narcotic and cultivated with horticultural techniques. Large-scale commercial production of cannabis was uncharted territory for those of us QA Professionals in 2013. One had to be knowledgeable and creative in their application of all these rules to the LP site.
The two main questions to answer at start-up were the basics ones, “What does QA mean for this industry?” and “How do we create and apply quality standards?”. Neither of these questions have simple answers, not even in established industries yet alone a in a complex LP operation. At the core, the mandate for QA is to ensure that a product is safe for public consumption, within the regulatory framework that govern the product. Specifically, the product must be produced according to written procedures, in a sanitary environment, using quality-controlled raw materials, and ultimately meets testing specifications. The QAP is the safeguard of all these points, and the role comes with a lot of responsibility.
Beyond those initial questions are the operational challenges of how to maintain these standards, be flexible under a shifting regulatory framework, as well as continuously improve within the organization. The Quality Management System (QMS) is the system to do this. The QMS provides structure, guidelines, and standards for the product and these systems can’t just be created from thin air.
CCI has developed a full QMS system of Standard Operating Procedures (SOPs) that are readily customizable to any facility. This was adapted from examples in pharmaceutical, food, and agriculture. Ultimately, a system was created that still allows for the flexibility required when the product is grown, rather than mixed according to a formula. Pharmaceutical systems knowledge introduced items like ‘document control’, ‘data integrity’, and security measures that were new to horticultural techniques. In order to assist new and upcoming LPs, These SOPs are designed to meet all of the needs for LP operations under the ACMPR – they have successfully supported dozens of applications and been inspected by Health Canada.
Within the past 5 years, there has been a development of industry standards for cultivation and sanitation procedures and practices, security, and testing requirements and methods. All of these processes are undergoing continuous improvement and changes. A QAP then needs to remain alert to the changing requirements, and in-tune to the Health Canada inspection trends and maintain the QMS to the current expectations.
A large, ongoing, challenge for new and existing producers is finding QA individuals who are familiar with cannabis or have experience with growing cannabis. Simply put, the short amount of time that a QA program for cannabis has existed means that individuals with cannabis experience are in short supply. To this end, CCI is proud to be offering courses to develop talent for the Quality Assurance industry sector, which provide personnel training against the backdrop of ever-improving industry quality standards, found here:www.cannabiscomplianceinc.com/training/programs/quality-assurance-associate. These courses are aimed at Quality personnel, through an introduction to QA, to increased specialization and management of a Quality system.
Having knowledgeable and experienced QA oversight within a facility ensures that the product produced meets standards that are designed with consumer health in mind. QA for cannabis means that the final product available for sale is consistent, the strength is accurate, and that the product is safe for use. QA for the cannabis industry will continue to be an important piece of an operation and has developed into one of the strong foundation points of the cannabis industry.
After 5 years, it’s no longer a joke.