The evolving world of quality and compliance for the global medical cannabis sector

The evolving world of quality and compliance for the global medical cannabis sector
© iStock/Augustas Cetkauskas

Global medical cannabis is a compliance business, want to know how Cannabis OneFive Inc. can help?

Regulators tend to draw on precedents from the pharmaceutical, consumer packaged goods (CPG), food, beverages and even natural health products for legislation. Cannabis OneFive, Inc. (C15) is a technology partner for Veeva Systems, Inc. (Veeva). C15 brings the Veeva regulatory and risk compliance platforms from the same sectors the cannabis regulators use for precedents. The world’s largest most successful pharmaceutical, CPG and largest brand companies use the identical platforms ( C15 brings to the global medical cannabis sector.

There is a distinction between medical cannabis, recreational cannabis and medical grade or pharmaceutical cannabis. Suffice to say, medical cannabis is not a pharmaceutical molecule or drug. While there are some cannabis derived drugs that have received market authorisation from an applicable regulatory authority, most of the medical cannabis EU export market will strive to be ‘pharma grade’ but will not be a pharma drug, per se. The need for quality medical cannabis products is simply an amazing grasp of the obvious: what is not obvious is the how to do this.

Besides the basic elements of genetics, strains, cost of growing/production, supply chains, off-take agreements, white labelling, and other common business operational activities, every producer has compliance activities for the regulators. Multi-sets of regulators – the domestic EU regulators and the export market regulators. The medical cannabis business is first and foremost a compliance industry.

How are these risks best managed? Look at the same precedent industries much of the regulatory rule sets are derived from – people, processes and technology manage these risks. Our message in this article is to highlight the specific role of technology in the quality equation.

The risks of non-compliance can include impounded product, product recalls, fines and other penalties, licence suspension or revocation, increased regulatory overview, slow approvals on products and exports, reduced revenue, reputation loss and even a potential out of business sign hanging on your facility. There are many examples in the media of producer fails with commensurate costs that lead to the loss of careers when the stakes become high.

C15’s solutions, for medical cannabis production, fits like a bullseye into a realm of regulatory compliance which falls neatly into our flagship product – C15QualityOne document control and quality management systems (QMS). Every company should have an end to end IT platform, of which QMS is a mission critical aspect. There is no one stop shop for such an IT risk platform, however with the selection of an ERP integrated with QMS, gets you almost all the way to having the platform painkiller you need to succeed.

To put in simple and stark terms if you aspire to EUGMP status and ‘pharmaceutical grade’ medical products then this level of quality is simply not possible to attain and maintain unless you have a document control and quality management system fully deployed. The next diagram clearly shows that our QMS is unified with document control and works in a highly integrated way with seed to sale and ERP’s. Content management of SOPs, training and proof of training for employees, and handling all quality events demonstrates, to a regulator, that the production process is under control and is a quality driven process.

We speak of our customers having a culture of quality. This comes down to a focus on GMP ‘type’ practices, especially for medical cannabis, independent governance structure for the quality assurance professionals, and a proper board approved budget for IT solutions.
We remain the leading choice in the global cannabis sector for unified document controls and quality management systems, for a reason: we want our customers to succeed.

Scott Samuel, B.Comm, MBA, J.D., LL.M., C.Dir
Founder and CEO
Cannabis OneFive, Inc.
Tweet @CannabisOnefive

This article will appear in Health Europa Quarterly Issue 11, which is available to read now.

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