If your company has any plans to get involved with the cannabis industry, be sure you know and understand all applicable regulatory requirements before getting started. Cannabis is a highly regulated industry and, as a result, quite expensive. Just meeting the requirements of Good Manufacturing Practice (GMP) can require a significant financial investment.
Note that GMP isn’t limited to the activities engaged in by cannabis processors. It also covers some activities common to growing and dispensing operations. For example, GMP regulations apply to how growers cut, dry, and express their plants. It is nearly impossible to be involved in the cannabis business without in some way being held accountable to GMP regulations.
GMP: A Brief Overview
Good manufacturing practice is not a single standard. It is actually a set of standards that apply to the manufacture of food products, pharmaceuticals, cosmetics, dietary supplements, and medical products. GMP standards are continually developed and maintained to ensure consumer safety. What are called guidelines are actually minimum requirements that manufacturers must meet in order to comply with the law.
GMP standards are maintained in the U.S., Canada, the UK, India, China, and most European countries. They are the domain of the Food and Drug Administration (FDA) in this country. One of the basic tenants of GMP regulations is that safety and quality must be purposely designed into products. Testing after the fact is insufficient to guaranteeing safety.
GMP and Cannabis Extraction
So, how does GMP apply to cannabis extraction? First and foremost, it applies in the sense that cannabis can be used as a medical product. If not the plant itself, at least the cannabinoids and terpenes extracted from it. Therein lies the foundation of GMP compliance.
Growers must maintain GMP compliance in order to provide biomass free from contaminants like algae and fungus. Contaminated plants cannot be sent to processors; they must be destroyed. It is in the best interests of growers to prevent contamination at all costs.
In terms of extraction, there are multiple ways to do it. Processors have a legal obligation to make sure they extract the materials they are after in a safe way. They are required to maintain the purity of their extracts; they are required to maintain clean and safe extraction equipment; they are required to test their extracts before using them to make retail products.
What GMP Covers
Knowing and understanding how GMP regulations apply to the practical task of cannabis extraction is just the start. There is more to it simply because GMP covers nearly every aspect of the business. GMP regulations extend to:
- premises and equipment safety
- product storage
- product development and testing
- personal and equipment hygiene
- staff training and policies
- record-keeping policies.
GMP regulations even extend to how companies handle complaints from both employees and customers. Companies have to be incredibly careful about everything they do. They also have to document everything as well. There is very little room for error in an industry that is constantly being scrutinized at the state and federal levels.
What It Means for Us
As a designer and builder of custom extraction equipment, GMP is something we have to worry about as well. We are tasked with producing equipment that will, at the very least, not inhibit cannabis processors from maintaining regulatory compliance. We push ourselves to go further. We design equipment that actually helps our customers maintain compliance.
If you are just entering the cannabis industry, know that GMP compliance is a significant responsibility. It is also not optional. If you fail to comply, you could lose your license.