Last week we kicked off a two part series on process validation. It’s a complicated topic that we receive many questions on, so we figured it was about time to revisit the subject. Last week’s post focused on the implications of process validation for cultivators. Today’s post is geared towards MIPs. Before you read on, remember, 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).
Before we dig in, quick reminder: We’re hosting a webinar on Wednesday July 12 at noon MDT to review testing regulations including process validation and potency testing requirements –
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. Whether you are a cultivator, MIP, or dispensary, this session will get your team up to speed!
First, let’s cover the basics. What is process validation? It’s an opportunity to validate that your products that are consistently contaminant free. Oversimplified, if a licensee tests every batch of product (of a given category/recipe) it produces for a certain period of time, has enough unique batches during that time period, and all of the tests are passing, that product 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 MIPs. First and foremost, it is important to recognize that for MIPs, process validation is product specific. So, if you operate a MIP that makes shatter, wax, and live resin, each must be validated individually. Or if you make cherry, peach, and grape gummies, each must be validated individually (because the ingredients differ among the flavors). If you operate a dual-use MIP with both med and rec licenses, you’ll have to validate separately for each license as well.
Additionally, it’s important to recognize that your process must be locked down and consistent when you start process validation. If you are tinkering with ingredients, equipment, run times, etc, then you’re not quite ready for process validation. Moreover, don’t forget that if you change your process after establishing process validation (what the MED calls a “Material Change”), you’ll need to do some additional testing to prove that change didn’t impact the integrity of your process.
Let’s take one particular product for one particular license. Every production batch must be tested for a period of at least four weeks. That doesn’t mean you need to test every production batch as a unique test batch (though many operators take this approach) – you also have the option of aggregating multiple production batches into larger test batches. Just keep in mind that there is a risk-reward consideration in this approach. By aggregating production 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 product that gets flagged into quarantine. We urge our readers to strike a balance that the business is comfortable with.
At the conclusion of four weeks of testing all of your production batches, we’ve got to look for two important benchmarks. First, all of these tests need to have passed. A failed test requires you to start over. Second, you need to have at least four unique production batches during these four weeks. Most of the businesses we work with almost always meet or exceed this requirement. However, if you don’t have four unique production batches represented, do not despair! You’ve got up to eight weeks to hit that number. Just keep in mind, every production batch must be tested continuously until you hit the mark.
So, in summary, if you test every production batch for four weeks, everything passes, and there are at least four unique production batches represented among the data, that particular product is process validated for that license! Keep in mind that this process must be replicated for each product and each license. Even if you operate dual-use MIP that utilizes the exact same SOPs for both med and rec, the product must still be evaluated separately.
Moreover, all of the above logic can also be applied to potency validation for edibles that contain 100 mg or less of THC. However, instead of ensuring that all of the tests pass contaminant testing for a period of at least four weeks, you must determine that all of the production batches pass homogeneity testing and are within the allowed potency variance.
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 testing for your MIP each month. It’s probably a lot, right? It’s not uncommon for a MIP to spend tens of thousands of dollars a month on 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.
Let’s take a step back for a second and consider the complexity of all of this. If you manage a dual-use MIP with 30 edible SKUs on both the medical and rec sides, you’re looking at tracking 120 unique validations (60 for contaminants, 60 for potency). Nobody said this would be easy, but there is some real payoff here. That’s where Complia comes in.
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.
If you’re not using Complia, 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 compliance. To schedule a demo, drop us a line at firstname.lastname@example.org. We’re excited to hear from you!
Yours in Compliance,