To leverage first-mover advantage and justify lofty valuations, Canadian cannabis companies are looking to international markets. The most coveted is Europe, where medical marijuana regimes in countries such as Germany and Denmark are starting to take shape.
To ship to Europe, Canadian cannabis production facilities need to have European Good Manufacturing Practices (GMP) certification. Only six licensed producers have GMP certification, although many more claim to be “GMP compliant” or say they are actively pursuing certification.
Last month, the consulting firm Cannabis Compliance Inc. released a white paper on GMP, exploring the differences between GMP and the Canadian Good Production Practices (GPP) system. Cannabis Professional spoke with the report’s author, Karina Lahnakoski, CCI’s vice-president, quality and regulatory, about GMP certification. The interview has been edited and condensed for clarity.
Cannabis Professional: How much interest is there among Canadian cannabis companies to achieve European GMP certification?
Karina Lahnakoski: It’s increased enormously. It is hard for me to know overall the percentage [of companies pursuing it]. If I had to guess, based on the percentage of our clients working on it, up to 20 per cent. I was just at the ICBC conference in Berlin, and I would say 50 per cent of my conversations involved GMP.
CP: How different is Canadian GPP and European GMP?
KL: I would say that the GPP framework is a very strong framework, it is just different in many ways. When you look at each section of GMP, there are numerous small things that need to be implemented, and then there are a couple of big ones. Pretty much every quality system will have to be tweaked in some way, either increasing the level of documentation, or implementing additional programs for those areas.
CP: For companies pursuing GMP, what do they typically need to change first?
KL: First, I would always say the validation program. Validation is a process by which you prove that you can consistently perform to a standard. So if I say I can produce this batch of cannabis to a certain specification, say per cent THC, I need to prove that, and I need to do it three times under a standardized protocol, and I need to get the same results.
The other big one is the stability program. It is not a requirement under GPP to assign an expiry date to your product, but it is a requirement under GMP. To generate enough data to show an expiry date, you need to have real time data, which means you need to store it under the recommended storage conditions for the duration of the expiry date. So you if you want to put out a product that says I have a one-year expiry date, you need to store it and test it over one year, and obviously that takes a lot of time.
There is actually another standard for stability studies: it's an ICH (International Conference for Harmonization) guideline. You need to store your product in the same packaging configuration that you'll be selling it in. So if I want to put it in an HDPE bottle, I need to do the stability testing in an HDPE bottle, and typically the program has you testing it at time zero, three months, six months, nine months, 12 months, 18 months-plus, depending on how long the stability date is.
You need to test it to the full stability specifications. So very important for cannabis will be showing that the per cent of THC and CBD are not declining; it will be looking at drying, for sure, because water is a factor always; it will also be looking at the microbial specifications and making sure that that's maintained over the duration of the shelf life.
CP: Can Canadian regulators certify that a facility is GMP complaint? Or do regulators have to come over from Europe?
KL: Under the MRA, the Mutual Recognition Agreement, Health Canada and European regulators have accepted the GMP standard as equivalent. So if you work in the drug industry, which is where I came from, Heath Canada will inspect you to GMP, and the EU regulators will accept that. However, at this point in time, cannabis is not included under the MRA, and Health Canada has regulated cannabis to the GPP standard, so they don’t do GMP inspections for GPP facilities. It’s not something that’s going to change any time soon. Right now, you do have to have a competent authority from your importing country come over and do your GMP inspection.
CP: So if I want to ship to Germany, for example, I have to get German regulators to come inspect my facility?
KL: That’s right. If I was the exporting company, I would have to have a relationship with an importer in the other country. It’s typically the importer that will schedule the inspection for your site. Once the importer has a letter of intent for trade to happen, then the competent authority will take notice of that and realize that an additional product is coming in from Canada, and they have the responsibility to come and inspect the site.
CP: How long do GMP inspections usually take?
KL: It can range from two to five days; it really depends on how many products they are covering under their scope, and it may take longer if they need to have translators on site.
CP: How long does it typically take between the first letter of trade being received and actual certification?
KL: It can take as little as three months, but it typically takes much longer, because there are a lot of things to arrange. The importer will also have to have their qualified person come over and do an inspection. The qualified person is the individual in the foreign country that takes responsibility for the release of the product to market. The importer would typically have that QP do an inspection before they bother having a regulator come over. So if there are any observations from the QP audit, the site will have to fix those before the regulator gets called in.
CP: How much does it typically cost to transition from GPP to GMP?
KL: It really depends on the state of your facility. I have heard some million-dollar range figures for facilities that needed complete infrastructure changes, but I’ve also seen facilities, especially those that are new builds, that were built with the right principals in mind. When we’re designing a facility, we always ask the client if they have any intention of doing GMP, and make sure that their floor plan is designed from the beginning the right way. Otherwise, down the road it will be too late to make those changes. If you’ve built right from the beginning, it might just be some small changes and might be a lower dollar value.
CP: How long until there are more harmonized regulations to better facilitate international trade?
KL: I think we have a long way to go. It’s just an inevitable part of where we’re at with the whole evolution of legalization worldwide. Every country really does need to focus internally right now, to get their legalization and their regulatory regime set up first. That should be a priority. The standardization will come later, but I do think we’re many years off from that.
Mark Rendell