Process Validation – A Valuable but Delicate Compliance Asset

Thankfully, the updated MED rules published November 30, 2015 finally allow for a somewhat reasonable and straightforward procedure for process validation.

Process validation allows licensed cannabis operators in Colorado to conduct a series of tests to demonstrate that their processes are robust and as a result, yield products that produce consistent lab results.  Process validation is broken into several categories including contaminants, potency, homogeneity, and residual solvents.  Currently, only Retail products may be process validated (stay tuned for Medical process validation!).  Take note, there are nuances to what is required depending on the type of product and the nature of the test involved.

Once process validation is complete, you’re off the hook for testing (sort of – see below) for one year.  This equates to enormous reductions in lab testing costs while simultaneously eliminating the man power required to sample, deliver samples, and aggregate data.

Product Type

Test Type

Minimum Number

of Test Batches

Minimum Time

Period (Weeks)

Maximum Time

Period (Weeks)

Flower

Contaminants

                  6                  6                12

Concentrate

Contaminants

                  4

                 4                8

Infused Product

Contaminants

                  4                  4                8

Edible

Potency

                  4                  4                8

Edible

Homogeneity

                  4                  4                8

Please note, contaminant testing includes analysis for microbes, mold & mildew, filth, and residual solvents.  Additionally, every harvest/production batch must be represented during the validation period.

So if you become validated are you off the hook for the year?  Not exactly.  The Complia compliance team strongly encourages operators to develop a voluntary ongoing testing program.  No one is perfect and it’s important to perform periodic spot testing to make sure your products maintain the highest level of integrity.  However, if one of these tests falls out of specification, you will be required to restart process validation for that specific product and testing category.  Additionally, if you make a “material change” to your process, you need to restart validation as well.

If you’re interested in learning more, take a look at R 1501 and R 1503 in the MED rules.  Have questions?  Drop us a line!

Complia is actively building a tool to help operators manage this process.  If you’re interested in learning more about this tool, please reach out!  Complia is here to help!

Good luck and happy validating!