GMP, short for Good Manufacturing Practice, is a set of ever-evolving standards that have the force of law in guiding food and pharmaceutical production in the U.S. and other countries.
Kim Stuck, founder of Allay Cannabis Consulting, calls GMP standards "above-and-beyond guidelines for food safety in manufacturing," adding, "It's essentially making sure everything in your facility is safe and working correctly and clean."
Laid out under the Federal Food, Drug, and Cosmetic Act and enforced by the Food and Drug Administration (FDA), the regulations refer to CGMP (or cGMP), with the "C" an abbreviation of "current" to indicate the continually changing nature of GMP standards.
GMP certification applies to food and beverage, cosmetics, and pharmaceutical manufacturers. Generally, the guidelines help manufacturers ensure products are suitable for human consumption.
Stuck says it allows cannabis manufacturers to essentially self-regulate. "GMP is really great for this industry because it shows which companies are caring about [health and safety issues]," she explains.
It applies to both THC and CBD manufacturers. "It's going to be very soon that the FDA comes out with their [CBD] regulations. The FDA put together the regulations for GMP, so they're going to be fairly similar," says Stuck. "Most of the things [CBD manufacturers] need to do are already written in FDA food code."
Stuck says the primary GMP pain points for cannabis companies involve structural and sourcing issues. "One of the main things is just the way the facilities are built: You have to have a certain number of hand sinks, a certain number of fixtures," she says. "The number-one reason I ever closed any business when I was a regulator (with the Denver Department of Public Health & Environment) was because they didn't have enough hand sinks."
Improper ingredient sourcing is another common issue that can lead to product recalls, adds Stuck. "When you're buying essential oils or any other ingredient, it needs to be a food-grade product made in a licensed facility that is regulated by the FDA. And if they're not, you shouldn't buy it."
Stuck is quick to point out that the characteristics of the cannabis plant itself present challenges. "There's a lot of food safety issues with cannabis because it's not the same as any other crop," she explains. "When we harvest apples, we throw them on the ground and then we take them in to a warehouse and wash them, and then we can ship them out. With cannabis, that washtub doesn't exist."
Colorado Springs-based Hemp Depot became the first Allay client to complete the GMP certification process in December 2019. Stuck says she has another eight clients working towards it.
Hemp Depot was certified after six months, but that's on the short end of the spectrum. "On average, it's 160 billable hours to get the documentation done, and that doesn't include the mock audits that we do," says Stuck. "When the certifying body comes in to do the audit, a lot of times we're onsite, and we also write a corrective action plan if there are any nonconformities."
While the enforcement mechanism is under the FDA umbrella, certifications are accomplished by accredited third parties. "It's not anything too crazy, but it's a lot of documentation," Stuck says of the process. "More than 70 documents have to be created to even apply for GMP certification."
With operatives in Colorado, California, and Oregon, Allay has been offering GMP consulting since mid-2019. Contact Kim Stuck for more information.