Current Good Manufacturing Practices (cGMPs) are essential for ensuring the safety, quality, and consistency of all types of consumer goods.
According to the U.S. Food and Drug Administration, cGMPs for pharmaceuticals “contain minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing of a drug product. The regulations make sure that a product is safe for use, and that it has the ingredients and strength it claims to have.”
But unlike pharmaceuticals or food products, the cannabis industry and cannabinoid products are not subject to FDA regulations.
This week, we hosted Tyler Williams and Darwin Millard from CSQ - Cannabis Safety and Quality for a special webinar “Why GMPs are Crucial for Cannabis Businesses,” which looked at why cannabis companies need GMPs, why they’re a sound and necessary business decision, and how they can be implemented in the workplace.
Here are some key takeaways:
Running a cannabis business can be high-paced and very stressful. There can be a tendency to look at operational guidelines as yet another hassle to shoehorn into the day, but the benefits far outweigh the time and effort needed for implementation.
“Essentially GMPs act as a safety net, ensuring that every batch of the products being produced meets the same high-quality standards consistently,” Tyler Williams said.
Darwin Millard added that while there is a tendency to look at GMPs as “being overly burdensome or costly and unnecessary due to the lack of regulatory mandate on the cannabis space,” these guidelines “are really a tool that can be used to lower operating costs and to improve efficiency and streamline compliance.”
The repeated, daily use of GMPs helps companies build a culture of safety - and also to collect the data necessary to optimize daily operations.
“By having good manufacturing practices in place, you start to collect data which provides better visibility over your processes. This means you can track nonconformities much quicker. This means you're being more efficient,” Millard said.
He added that this greater efficiency “means you’re able to quickly reduce your spending on rework, so you’re focusing more on product quality and safety, mitigating potential risks that can come down the road.”
Implementing GMPs can require an initial investment of time and money. But this investment pales in comparison to the cost of not implementing GMPs.
Both guests spoke about the devastating costs that product safety recalls incur, with Millard saying that there are only two types of companies - “those who have had a recall and those who will.”
“Let’s say an incident occurs at your facility and you have to conduct an investigation to figure out what happened. If you don't have any data for what was going on at the time of the incident, how are you going to track what happened?
He added that risk can never be erased, but GMPs go a long way towards mitigating those risks.
There is much that makes the cannabis industry unique. Each state’s cannabis industry functions as an independent market and all products sold in that market must be produced within the state and subject to its regulations.
“It makes it really hard to have consistent products across multiple states because you have different requirements implemented by the states,” Williams said.
But GMPs can help multi-state operators ensure consistency across all of these jurisdictions, Williams said.
Implementing GMPs and creating a safety culture requires regular, formal training.
“Training is critical and one of the foundational elements of good manufacturing practices,” Millard said.
He added “everyone who performs a function within the business, especially if that directly relates to consumer safety and product quality, needs formal training. It needs to be defined and then it needs to be evaluated that they've actually gotten that training and can perform their job function.”
If you missed the live stream of "Why GMPs are Crucial for Cannabis Businesses," you can still catch it on-demand here.