Here at Complia HQ, we get lots of miscellaneous compliance questions from readers in Colorado and from across the country. We love these questions and are always happy to help (so please keep the questions coming!). Interestingly, in the last few weeks, we’ve received countless inquiries surrounding process validation. Process validation may sound like a boring subject, but let’s be clear: if you are not taking advantage of process validation, you are leaving money on the table (and depending on the nature of your business, we may be talking about a lot of money). We covered the topic in our blog more than a year ago and also wrote a piece for our friends over at Cannabis Business Times. We also wrote about some updates to process validation back in September.
Because our readership base has grown like crazy lately (thank you for spreading the word!), and because of the number of inquiries we’ve received on the topic, we decided it’s about time we revisit the subject of process validation. This will be the first of a two part series on the subject. This will post will focus on process validation for cultivators whereas the next post will focus on process validation for MIPs. We’re also hosting a webinar on Wednesday July 12 at noon MDT to review testing regulations including process validation and potency testing requirements – register here! This is a must-attend event for any members of your team that are involved with sampling/testing so be sure to spread the word.
First, let’s cover the basics. What is process validation? It’s an opportunity to validate that your process-produced products that are consistently contaminant free. Oversimplified, if a licensee tests everything it produces for a certain period of time (determined by the product type), has enough unique batches during that time period, and all of the tests are passing, the licensee may be exempt from contaminant testing for a full year. Now, we certainly don’t suggest cutting off your contaminant testing program; rather, we recommend crafting a voluntary contaminant testing plan that is less burdensome than testing every batch (the baseline requirement for contaminant testing), but still tests a meaningful number of samples to ensure your facility doesn’t have any snafus.
Now, let’s drill into the details for cultivation licensees. First and foremost, every harvest batch must be tested for a period of at least six weeks. That doesn’t mean you need to test every harvest batch as a unique test batch (though many operators take this approach) – you also have the option of aggregating multiple harvest batches into larger test batches. Just keep in mind that there is a risk-reward consideration in this approach. By aggregating harvest batches into test batches, you reduce the number of tests you need to perform and subsequently reduce your testing costs. However, if one of those aggregated tests fails, you’re stuck with a much larger quantity of plant material that gets flagged into quarantine. We urge our readers to strike a balance that the business is comfortable with.
At the conclusion of six weeks of testing all of your harvest batches, we’ve got to look for two important benchmarks. First, all of these tests need to have passed. A failed test required you to start over. Second, you need to have at least six unique harvest batches during these six weeks. Most of the businesses we work with almost always meet or exceed this requirement. However, if you don’t have six unique harvest batches represented, do not despair! You’ve got up to twelve weeks to hit that number. Just keep in mind, every harvest batch must be tested continuously until you hit the mark.
So, in summary, if you test every harvest batch for six weeks, everything passes, and there are at least six unique harvest batches represented among the data, your cultivation license is process validated for all of your plant material for that license! Keep in mind that this process must be replicated for each cultivation license. Even if you operate collocated OPC licenses that receive the same water, nutrients, and light, the licenses must still be evaluated separately.
I encourage each of our readers to pause for a moment, open up Quickbooks (or whatever you use to manage accounting), and calculate how much you’re spending on contaminant testing for your OPC each month. It’s probably a lot, right? It’s not uncommon for a cultivator to spend tens of thousands of dollars a month on contaminant testing. And the craziest thing to consider in all of this… you might already be process validated and you don’t even know it. You are leaving money on the table.
This is a complicated topic, no doubt about it, and operators have few tools to help them manage these processes. It’s this challenge (among others) that inspired us to create Complia. Once your data is streamlined in our system, Complia will automatically crunch the numbers to help you determine if you are process validated and when your validation expires. You’ll also enjoy the benefits of having all of your data securely stored and organized in our system so that is easily accessible by all relevant stakeholders within your business.
We haven’t even scratched the surface of potency testing requirements which are totally separate and unique from contaminant testing requirements, and which are arguably more complex because potency testing must be tracked and managed by strain and license. So if your business operates four cultivation licenses with 30 strains in each, we’re talking about monitoring and maintaining 120 unique datasets all of which are subject to regulatory scrutiny.
If you’re not using Complia, your business needs to be leveraging the newest technology and you’re likely throwing your testing budget to the wind. It’s time you join the most sophisticated operators in the industry and leverage Complia to stay on top of your compliance. To schedule a demo, drop us a line at firstname.lastname@example.org. We’re excited to hear from you!
Yours in Compliance,