The barriers to entry for a marijuana testing facility in Colorado are relatively low. As a result, this has led to a wide variance in test methodologies and the results laboratories report. This variance can be frustrating for marijuana businesses as they depend on accurate data for product formulation/dosing, maintaining/improving process controls for extraction, and truth in labeling for consumers.
So how should a marijuana business find the right laboratory?
There are different approaches a laboratory can take to demonstrate competency in marijuana testing:
2) ISO 17025 accreditation (optional); and
3) by following current Good Manufacturing Practices (cGMP) – the quality system used to regulate Pharmaceutical manufacturing and QC testing.
GMP – Verification of Scientific Methodology, Equipment & Process Validation, Routine Analysis
cGMP is undeniably considered the Gold Standard in Quality Control testing. The FDA regulates the Pharmaceutical Industry based on GMP standards to ensure products are manufactured and tested under the highest level of scrutiny to ensure consumer safety and accurately reported data.
cGMP is an industry-specific standard prescribing to what must be done to ensure product safety and efficacy, including an accurate and reliable testing framework. Extensive validation and process controls are only a few of the components that make up one of the worlds most comprehensive system designed at generating accurate and reproducible products and test results.
Agricor Laboratories is the only Licensed Marijuana Testing Laboratory to implement a cGMP framework and continuously improve to maintain cGMP standards.
ISO 17025 – Broad General-Purpose Scope
ISO 17025 is a generic, business focused standard which supports the effective management of quality initiatives and customer satisfaction. ISO 17025 is considered more of a broad-spectrum documentation and record keeping exercise, requiring a testing lab to estimate measurement uncertainty and participate in a formalized proficiency testing program.
While there are some similarities between ISO 17025 and cGMP in maintaining Quality Systems, a significant difference between these two frameworks is the requirement to control processes. ISO 17025 requires a certified laboratory to simply estimate the measurement of uncertainty, where the GMP framework requires a laboratory to control uncertainty through rigorous validation and demonstration of scientifically sound principles.
Agricor Laboratories is ISO17025 Certified, A2LA Accredited, in scope for all available current testing requirements.
MED/CDPHE – Entry Level
The MED/CDPHE Certification is an introductory level certification designed for the beginning entry-level laboratory to become classified as a certified marijuana testing laboratory. Minimum experience is necessary to enter the testing space with little-to-no scrutiny placed on demonstrating test results are accurate and reproducible.
Agricor Laboratories is Certified for all current mandatory testing requirements.