Process Validation Tutorial
Our guide to understanding how Process Validation works
“Process validation is the analysis of data gathered throughout the design and manufacturing of a product in order to confirm that the process can reliably output products of a determined standard. The purpose of process validation is to ensure varied inputs lead to consistent and high quality outputs. Process validation is an ongoing process that must be frequently adapted as manufacturing feedback is gathered.”
The MED allows Licensees to test for a specific amount of time with a specific number of Samples to demonstrate that their manufacturing process is performing as expected and within regulatory guidelines. Before we begin, we recommend reading section: 4-120 – Regulated Marijuana Testing Program: Contaminant Testing (B) on page 185 of the Colorado Marijuana Rules 1 CCR 212-3.
4-120 – Regulated Marijuana Testing Program: Contaminant Testing (B)
Which tests are required?
|Product Type||Required Contaminant Tests|
|Flower||Microbials, Pesticides, and Heavy Metals|
|Solvent-based Concentrates||Residual Solvents, and Heavy Metals|
|Heat/Pressure/Water-based Concentrates||Microbials, and Heavy Metals|
|Infused Products||Microbials, and Heavy Metals|
Timeframe to complete Process Validation
|Flower||Minimum of 6 weeks, maximum of 12 weeks|
|Solvent-based Concentrates||Minimum of 4 weeks, maximum of 8 weeks|
|Heat/Pressure/Water-based Cocentrates||Minimum of 4 weeks, maximum of 8 weeks|
|Infused Products||Minimum of 4 weeks, maximum of 8 weeks|
How many tests are required?
|Product Type||Required # of Test Batches|
|Flower||Every Harvest Batch produced in a 6 – 12 week time period. Minimum of 6 Test Batches.|
|Solvent-based Concentrates||Every Production Batch produced in a 4 – 8 week time period. Minimum of 4 Test Batches.|
|Heat/Pressure/Water-based Cocentrates||Every Production Batch produced in a 4 – 8 week time period. Minimum of 4 Test Batches.|
|Infused Products||Every Production Batch produced in a 4 – 8 week time period. Minimum of 4 Test Batches.|
How long does Process Validation last?
Process Validation is effective for one year. On the anniversary of achieving Process Validation, the Licensee will need to revalidate their manufacturing processes for contamination.
After successfully obtaining Process Validation, the Licensee must submit one Harvest or Production Batch every 30 days for all required contaminant testing.
Ongoing Testing: Sample Failure Procedures
If the Ongoing Test Sample fails, the licensee must do the following two steps:
Follow Rule 4-135 (B)
For Microbial Contamination, Residual Solvent Analysis, and Heavy Metals, submit two Samples for confirmation testing from the Harvest or Production Batch that failed. For Pesticides, two additional Samples will be pulled from the original Harvest Batch that was submitted.
Submit Three new Harvest Batches
In order to maintain their Process Validatation, the Licensee will need to submit Test Batches from three new Harvest or Production Batches within no more than 30 days. If any one of the three submitted Test Batches fails, the Licensee shall re-validate its process for contaminants.
Flower – Process Validation Examples
In this scenario the Licensee submits Samples every week for 6 weeks and all submitted Harvest Batches pass.
The Licensee fails a Test Batch in Week 3. They pass Process Validation in the next 6 weeks.
The Licensee is a smaller grow and harvests every other week. The Licensee passes Process Validation in Week 11.
Concentrate/Infused Product – Process Validation Examples
In this scenario the Licensee submits Samples every week for 4 weeks and all submitted Production Batches pass.
The Licensee fails a Test Batch in Week 3. They pass Process Validation in the next 4 weeks.
The Licensee is a smaller MIP and produces every other week. The Licensee passes Process Validation in Week 7.