Get Ahead of Federal Regulation with GMP Compliance

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Things change every day in the cannabis space, and that’s not going to stop anytime soon. The industry is brand new, and despite varying degrees of legality in more than half the United States, cannabis remains a Schedule I drug at the federal level. Because of that distinction, federal regulatory bodies have been slow to mandate the consumer safety protocols that are standard in every other industry that creates food or pharmaceutical products for human consumption.

With chatter about federal cannabis legalization and descheduling growing louder, now is the time for cultivators, manufacturers, and processors to take a serious look at Good Manufacturing Practices (GMP), also known as “current Good Manufacturing Practices” (cGMP). Put simply, GMP compliance relies on a system that helps companies maintain high levels of quality, scale operations safely, ensure consumer safety, and avoid potentially costly issues related to shutdowns.

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Taking the next step

Cannabis companies in most jurisdictions already are subject to check-ins by local health departments. But outside local mandates, there’s no real pressure for cultivators, manufacturers, and retailers to take the next step and earn GMP certification.

Well, I’ll just say it: If you want to survive in a federally regulated landscape, GMP compliance will be a necessity. If you become certified now, before legalization, you’ll be way ahead of the competition. Even if federal legalization is delayed—again—you’ll still be in a better position to meet increased consumer demand for quality and transparency, and you’ll be able to scale your business along with growing markets. In any scenario, GMP certification in cannabis is a win-win.

GMP helps ensure consumer protections, especially in industries like food and pharmaceuticals. Because it’s often difficult for consumers to detect ingredients’ quality, concentration, or chemical formulation in any one particular product, GMPs serve to provide verification, quality assurance, and more.

GMP is mandated by the Food and Drug Administration (FDA) for pharmaceuticals and many other manufactured products. Since cannabis products are consumed as medicine in legal markets across the country, it’s only natural the FDA inevitably will mandate the same certification process for cannabis products.

An overarching plan

GMP certifications aren’t just about the finished manufactured product. They cover the quality of materials being used; the safety, cleanliness, and efficacy of the machinery and facility; storage methods; staff training; protocols; documentation; and more.

You can’t fake good documentation, supply chains, or safe storage, and a single quality test from a third-party lab can’t make up for other holes in manufacturing processes or reduce the potential for future contamination from bad storage or handling protocols. Quality must be assured throughout the process, and that’s where GMP comes in.

The good news: In many cases, cannabis companies—without even knowing it—are really close to meeting the standards set forth by GMP. After all, GMP is a baseline minimum. That means meeting the standard or becoming certified sometimes requires only small changes or adjustments to a business’ processes, supply chains, or documentation methods.

One prominent U.S. CBD brand worked with my colleagues and I for only eight months before successfully earning its cGMP certification. To prepare for the certification, we conducted an on-site mock audit, which covered all areas of food safety and quality management. The client sailed through the actual audit with no issues at all, illustrating the process needn’t be onerous.

GMP certification can help set your business apart, and it’s well within reach. Nothing is slowing down in cannabis, and it can be tempting for busy operators to kick this can down the road. But I’d urge you to do your research and set a goal to be GMP certified as soon as possible. You’ll thank yourself in the long run and avoid any disruption once federal legalization becomes a reality.


Kim Stuck Allay Consulting

Kim Stuck is founder and CEO of Allay Consulting, a compliance strategy and services provider serving the hemp and cannabis industries. Previously, she served the City of Denver as an investigator covering cannabis cultivation, manufacturing, and retail. Stuck holds accreditations including certified quality auditor (CQA) and certified professional of food safety (CP-FS). She has been a member of ASTM International’s cannabis standards committee since its inception.