What is GMP, and Should You Care?

So, what do you need to know to access that market?  For starters, you should know about the minimum requirements for importing cannabis into the EU.

What is GMP?

The EU has standards called Good Manufacturing Practices (GMP or EU-GMP) that are required for medicinal products. As cannabis is only legal as a medicine, all cannabis must meet GMP standards, and it’s much more comprehensive than the standards required here in Canada. It outlines more stringent measures during the manufacturing process (i.e., after harvest) and holds manufacturers to a higher standard of quality. 

The European Commission has outlined all the requirements here.

How is it different from GPP?

In Canada, growers have to adhere to GPP, or Good Production Practices, which is the standard required for licensed producers as per Part 5 of the Cannabis Regulations. This was designed by the government as the minimum standard required to guarantee consistent health and safety in cannabis production. These regulations outline requirements for both cultivation and processing activities. 

GPP covers a lot of the same topics and aspects of the manufacturing process as GMP (for example, quality assurance testing, packaging and distribution, documentation, and maintaining a sanitized environment), but in general, it isn’t as stringent. It’s still fairly rigorous, though, so GPP acts as a subset of GMP - when it comes to the post-harvest flow, anyway. However, there’s yet another standard called Good Agricultural and Collection Practices (GACP) that’s a more stringent international standard for cultivation and harvest, and it is required if you are cultivating as part of a GMP facility.

Some examples of topics covered by GMP that are omitted from GPP include far more significant monitoring of environmental conditions, certain types of analysis for recalled products, detailed Quality Management System (QMS) planning, and various procedures for risk analysis of all materials used within the facility.

Why would I want GMP for my facility?

You don’t need to meet GMP standards here in Canada. If you’re selling to the Canadian market, GPP is perfectly fine and is what most producers do.

But if you’re looking ahead and planning a long-term vision of selling your product in Europe, even if it’s a few years down the road, you may want to consider GMP in the early stages of your business.

Since GMP is more strict than GPP, it can be complicated to suddenly decide to become compliant in the EU using a facility built to Canadian standards. Your entire facility needs to be built to different standards if it’s going to be GMP-certified, so on a financial level - it makes far more sense to build it to that standard from the get-go, as a retrofit is incredibly expensive.

It’s not just Europe that uses GMP… other countries around the world have variants of it, so considering your business goals early on may give you a clue as to whether the investment in GMP is for you. 

The big question is… do you want to export? If not, the extra expenses, time, and work associated with GMP might not be worth it for you.

Things to keep in mind if you decide GMP is important for you 

GMP might not be for you. Getting certified can be lengthy and costly.  But, of course, the tradeoff can be quite lucrative.

The facility itself must be built to GMP standards; otherwise, you may need such extensive renovations that it is not financially feasible. By considering the EU market from the start, you can ensure your facility was designed for GMP compliance, your staff are already versed in the procedures, and your software can meet the demands of stricter regulations.

GMP requires more data to be tracked. Additionally, if you’re using a digital system to track your data (e.g., a software system like CertiCraft), the system must be built to GMP-validatable standards. This means that the software was well-designed from the start, has good documentation showing how it was designed intentionally at every step and has automated tests that can be run to prove that the system works as it is designed.

Most seed-to-sale systems in North America are not built at GMP validatable standards since that requires far more time, work, forethought, and care to build. At CertiCraft, we’ve built our software to the standards from the beginning of our existence - because that is how you create good software. We did not realize it was required to be GMP validatable until a year after we started! We’re thankful that our adherence to best software development practices now allows our customers the opportunity to access the big emerging market in Europe.

This article was written in tandem with Mike F.