Do You Know What GMP and cGMP Are? You Should.
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Walking into a grocery store, do you question whether or not the meat at the deli is safe to eat or if the frozen meals were prepared in a clean environment? Chances are, you've probably never thought twice about it. But when stepping into a medical or recreational cannabis dispensary, you may be less confident about the safety of the products on the shelves.
Herein lies the difference between an established, well-regulated industry (food) and a brand new emerging industry with no federal regulation or guidance (cannabis).
Most consumers assume that products sold on grocery store shelves are safe. For good reason—the current regulations enforced by the FDA or the USDA on the food industry ensure the quality, safety, and efficacy of the products you purchase.
As the cannabis industry inches towards federal legalization, it would be wise for product manufacturers to implement the same rules followed by the food, dietary supplement, and drug industries. Here's what they are.
GMP and cGMP
Good Manufacturing Practices (GMP) outline the conditions and practices the industry should follow for processing safe products under sanitary conditions, including personnel, plant and grounds, sanitary operations, sanitary facilities and controls, equipment and utensils, processes, and controls, warehousing, and distribution, and defect action levels considerations.
GMPs provide the public with peace of mind that the food they consume won't make them sick or cause harm. Many companies require GMP audits, which are comprehensive, third-party inspections of a production company. It is meant to identify operational flaws and legal violations.
Another very similar acronym, "cGMP" is referenced throughout the more advanced and superior audits. The "c" in cGMP stands for "current," which implies that industry best practices are not stagnant and continue to change as the industry evolves.
With the cannabis industry still in its infancy, staying current is crucial for any company to consider. As scientific discoveries are made and new technologies emerge, industry best practices will progress in ways similar to how "GMP" evolved into "cGMP.
GAP & cGAP
GMPs are not the only safe practice measures employed by companies. Good Agricultural Practices (GAP) are the basic environmental and operational conditions necessary to produce safe, wholesome agricultural products. As you may have already guessed, the "c" in cGAP also stands for "current," which implies that good agricultural practices, just like good manufacturing practices, change with the industry. Certification Bodies, or organizations that perform audits like this for the most part, only offer GAP or GMP audits. Still, since the cannabis industry is constantly changing, it's not long before these practices become yesterday's news. If a facility becomes cGMP or cGAP certified, not only will the facility be more confident in being up-to-date, more extensive certifications are brought within reach, such as becoming Certified Organic or achieving a Cannabis Safety & Quality (CSQ.
What this means for cannabis
When companies do not follow cGMPs, this could lead to a brand being the root cause of a legitimate public health concern. An incident like this should not be taken lightly. Consumers' lives are at risk when product manufacturers disregard cGMPs and other industry best practices.
While local cannabis regulations generally require finished product testing, testing alone is inadequate to ensure product safety and quality. For the most part, testing is done on a small sample size of a much larger batch. For example, a cannabis manufacturer may produce a batch of 100,000 products but only be required to test 10 of them. Therefore, cannabis products must be manufactured following cGMPs to ensure that safety and quality are built into every step's manufacturing process.
A company in Michigan last year had over 3,000 pre-rolls recalled because someone caught an employee licking them. Evidently, this employee mistook a licensed cannabis facility for his living room.
Good hygiene protocols are the essential building blocks of meeting current Good Manufacturing Practices. It's easy to blame the individual employee accused of licking the pre-rolls, but the management team that allowed malpractices at the facility is equally at fault. Even though this was an issue with basic cGMPs, the intentional adulteration and lack of employee training are the underlying causes for concern. These core issues go above and beyond your basic good manufacturing practices.
Although essential, following cGMPs doesn't necessarily guarantee smooth sailing, especially for an unpredictable industry like cannabis. There are a lot more aspects to safety and quality than just cGMPs.
Take supplier approval programs, for instance. Last year there was an FDA recall of hemp and CBD products that were contaminated with lead. Regulators traced this issue back to the supplier of their droppers for tinctures. It's clear that the supplier of the application device lacks a robust supplier approval program, which is another process food safety workers are somewhat familiar with, and oddly enough, are not covered in cGMPs.
There are generally two types of audits in the food safety world: GMP and Global Food Safety Initiative (GFSI), and you don't typically start seeing verification of supplier approval programs until reaching the GFSI-level audit. The GFSI is part of the Consumer Goods Forum, consisting of retailers and manufacturers who benchmark food safety standards. Requirements are based on international standards, and the idea is that once you are certified at the GFSI level, it's accepted by all subsequent certifications. As their saying goes, "Once certified, accepted by all." Compared to GMP certifications with varying, non-interchangeable rules across the U.S., Canada, and Europe, a one-and-done scenario from a GFSI audit may be the easier route, especially for companies exploring international expansion.
No matter if your business has plans to go global, broaden its national reach as an MSO, or keep the lights on once the federal government legalizes cannabis, a cGMP certification will be a handy tool.