As most of you are already aware, some major rule changes take effect January 1. Over the coming weeks, we’ll be writing about many of these changes. Today, we’re going to cover some of the major updates to testing regulations. Specifically, we’ll discuss changes to potency testing requirements as well as process validation. If aren’t already familiar with these requirements, we’d encourage you to check out some of our previous blog posts on the topic here (OPCs) and here (MIPs).
In this post, we’ll hone in on exactly what’s changed. Let’s start with potency testing for flower/trim. As you might remember, each strain must be tested at least four times (per license) with each test separated by at least a week. The intention is that you test your first few batches to get an understanding of the baseline potency profile. After these first four tests are complete, you were previously required to perform an additional test on that strain every six months. However, starting January first, this requirement has changed to one test every three months. While this will certainly increase your testing costs, it will also help businesses and consumers have a more accurate understanding of the cannabinoid profile for each of your strains.
As for process validation, the baseline requirements for establishing process validation have not changed. As a reminder, businesses can establish process validation by testing all of their batches for a certain period of time (dependant on product type) and obtaining only passing test results. There also need to be a minimum number of tests during that time frame (also dependant on product type). Check out our linked posts above for a refresher on these requirements. However, there are now ongoing testing requirements throughout the validation year. Whereas previously you were off the hook for the year once you finished up validation, you must now perform some ongoing testing after the validation is established.
In the case of contaminant process validation, it is required that you perform at least one contaminant test per month after validation is established per product category. As for potency process validation (applicable for infused products only), one test must be performed every 90 days. In cases where a particular product isn’t produced/harvested during a defined ongoing testing window, just be sure to test the next batch that is produced. For example, suppose you establish process validation on March 1, but don’t produce that product again until April 15. In this case, you haven’t fallen out of compliance for failing to test within 30 days because there were no batches to test in the 30 day window. However, be sure to test the first batch you can, even if it’s beyond 30 days.
MED testing regulations are some of the most complex and difficult to adhere to. Thankfully, Complia’s test data module does all of the heavy lifting for you. Our team has been working around the clock to reconfigure our system’s logic to reflect these requirements. When the clock strikes midnight to ring in the new year, Complia’s system will be updated to reflect these new requirements.
Complia is the only software solution available to the industry that tackles these challenges. Once your data is entered in the system, Complia keeps you on track with these regulations by showing you exactly what needs to be tested and when. Want to see it in action? Drop us a line today to setup a demo – firstname.lastname@example.org.
Remember, these aren’t the only changes that impact testing so be sure to check out the new regulations on your own. In future posts, we’ll provide updates to more testing changes as well as changes elsewhere in the regulations.
We wish everyone happy holidays and a prosperous and healthy new year!
Yours in Compliance,