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Rachel Mann

Risk Management

The Rising Need for Quality Control Within the Cannabis Industry

The smart move would be for producers to treat their cannabis as if it were a pharmaceutical drug

Published: Thursday, April 11, 2019 - 12:03

With medical cannabis being legal in Canada since 2002, and recreational use becoming legal in 2018, Prime Minister Justin Trudeau’s promise to his country has caused a storm.

This legal framework has given Canadian companies the leverage to lead the cannabis industry to new heights. Not only supplying to Canada, companies have now seen an opportunity in Europe, where more countries are moving toward a less stringent approach concerning cannabis. The decision to move to more relaxed regulations even hit the United Kingdom in 2018, when the government legalized usage for medical purposes, joining countries like Germany, Denmark, Ireland, and Greece.

Despite what one’s view on this subject may be, demand is clearly extensive, with industry experts like Stephen Murphy, co-founder of Prohibition Partners, predicting the market will go “from zero to €56 billion (£49 billion) in a decade.”

However, as the industry grows, the climate in which it exists is changeable as more countries—and therefore governing bodies—are setting regulations and requirements for quality and compliance to steer clear of the illegal drug market.

Regulations are always going to have a place in the cannabis industry. One of the strongest arguments for legalization, to any extent, is the drive away from the black market, and in order to do that the industry must be policed to some extent. A lack of legislation in Europe has meant that 90 percent of cannabis plants in the Netherlands were reported to have pesticides on them in 2016. A shocking percentile when one considers the harmful effects pesticide residue can have on one’s health. Each country in Europe has different laws concerning cannabis. The lack of a central regulatory body that covers cannabis in Europe means that the responsibility for the quality of the cannabis must fall to the producer.

Acting assiduously in this environment is critical because regulations vary across the globe. Up till now, testing of cannabis has been sporadic, and there is no universally agreed standard to which producers or testing labs must adhere. The smart move would be for producers to treat their cannabis as if it were a pharmaceutical drug. Doing so, they would then be testing the “drug” to chemical, physical, and microbiological evaluations to ensure the quality and safety of the product. This would hopefully lessen the stigma attached to cannabis, since producers could prove they are testing it rigorously. This in turn might ease adherence to future regulations.

Suppliers should learn from the difficult regulatory history of the cigarette and nutraceutical industries. Before regulation in the United States, dietary supplements faced hesitant response, while cigarette companies were considered to have adverse moral and social impact—a response that could have been avoided if manufacturers from both the cigarette and supplement industry were “ahead of the curve.” Being proactive would allow suppliers to overcome challenges in reaching more territories with their product. Consequently, keeping up with this ever-changing regulatory environment is critical to maximize business enterprise. 

A quality management system, like Q-Pulse, can minimize risk and ease adherence to proper procedure, giving consumers and governing bodies the confidence that the product is of quality. Not complying with consumer or regulatory requirements wastes time and money because that can easily result in product recalls, product issues, and lawsuits—not just to control the issue at hand but to stop any future occurrences. This, considered with the harm done to the brand and company by being seen as dishonest, could be catastrophic.

With the pharmaceutical industry as a whole being continuously involved in modernization and improvement, one might assume that organizations would no longer be using a manual means to manage their quality processes. Yet, every day I speak to organizations using ring binders, filing cabinets, shared drives, and Excel spreadsheets to control their procedures. A manual system lacks oversight, control, and is time consuming—three features that are not accommodating to a highly regulated and changeable field.

An automated system provides organizations with an unrivaled advantage over a manual system. An electronic quality management system supports the evolving environment in which the cannabis industry currently exists. Whether the concern is for document control, supply chain management, or health and safety, an integrated system that supports continuous improvement could help in the transformation and success of this growing industry.

In my role at Ideagen, the UK-based, global governance, risk and compliance software firm, I have assisted organizations in the cannabis industry streamline their quality processes, helping them eliminate bureaucracy and add automation. This has resulted in procedures for regulatory compliance, safety management, and risk management becoming more manageable. The ability to prove that procedures are being controlled and show their effectiveness with a single integrated system allows more valuable time to be spent on improving organizational performance. This is critical for organizations operating in an innovative field.

To be prosperous, cannabis organizations need to preempt the likely regulatory rules they will face in the future and be proactive when tackling the quality of their product. How do they do this? Implementing an effective electronic quality management system will certainly help. Although categorizing their product as a pharmaceutical drug would mean putting the product through more rigorous testing and stringent rules, taking this initiative will pay off and set up cannabis organizations for new regulations that are sure to come.

Discuss

About The Author

Rachel Mann’s picture

Rachel Mann

As Ideagen's Sales Development Representative for the Life Science and Healthcare industries, Rachel is responsible for identifying the needs and requirements of new business leads. From a young age, Rachel has been heavily involved with healthcare and life science organisations as a career for her mother. This personal connection means that Rachel is dedicated to overcoming the obstacles and challenges facing these types of organisations every day.

Comments

The missing component

A very lucid and well thought out article.  All of the concepts and ideas mentioned are contained within one international standard;   ISO/IEC 17025:2017 General requirements for the competence of testing and calibration laboratories.  The standard has requirements for quality control.  What really is required to protect the customer is legislation requiring the analysis for this new product to be done by accredited testing laboratories that would be inspected on a regular basis.  The requirement can be based on looking at cannabis as a pharmaceutical drug or more likely a food product.  At least this way the quality component would be measurable.

The rest of your argument.

Cannabis is a bioremediator, an organism that soaks up toxicity from its growing medium. Cannabis can deliver these toxins (should they exist) to the central nervous system of the end-use consumer. Foremost, speaking from my research into recreational cannabis production, my chief concern is for "other ingredients" (some listed on product labels, most are not) in commercial-grade fertilizers, as well as chemicals Health Canada permits Licensed Producers of MJ to apply to cannabis plants under production. The concern stems from the fact that cannabis will be legal, by 17 October 2019, to consume through ingestion (e.g. "edibles," tinctures, and oils). My project concerns making the independent determination that the fertilizers (and their constituents) employed in the production of consumer-grade cannabis. 

Take, for example, 20-20-20, a fertilizer used in cannabis production. Canada policy framework oversees this range of fertilization products. 20-20-20 contains 20% Nitrogen mass/volume, 20% Phosphorous, and 20% Potassium. Yes? N-P-K. This leaves 40% mass/volume of the contents of the bag. Are these "contents" required to be listed by law? They are not. Does the FDA know what these contents are? It does not. So what's the problem? 

Recent and longitudinal research-1 indicates that nickel, mercury, lead, arsenic, and cadmium have been showing up in commercial- and consumer-grade fertilizers. What I propose is to make the determinations: i. that this is not occurring in Canada, ii. it is not occurring in cannabis production contexts, iii. that it is not occurring in cannabis production contexts that produce cannabis for human ingestion, iv. and to a greater degree, that safe alternatives to these chemicals/toxins (should they persist in products) be regulated into policies governing/approving pest control, and fertilizers "other ingredients," not simply for cannabis producers but especially in food crops policy formations. Cannabis consumers don't need to be eating nickel or mercury, or even lead.