ISO 17025 and More – What’s Next for Cannabis Testing Labs?
The rapid pace of cannabis legalization led to a mad scramble as laboratories entered the cannabis testing market. But that rush established poor laboratory practices that have caused product recalls and undermined the cannabis industry’s reputation. Increasingly, state regulators and even laboratories themselves are adopting standards to ensure safety and accurate labeling. With the correct systems in place, accreditations can demonstrate a laboratory’s ability to offer precise cannabis testing. ISO/IEC 17025 is already becoming an expected standard. But how do labs meet it? What can we expect next?
Cannabis Testing Complexity
From recent headlines, you could be forgiven for thinking the cannabis industry was out of control. A cannabis producer in Denver had to recall flowers due to the presence of cadmium. A Michigan company recalled cannabis vaping capsules due to possible pesticide contamination. A pesticide-free producer in Washington lost its crop after using FDA-approved food-grade gloves contaminated with an antimicrobial compound.
As you review incident after incident, you will find many cases where the proper testing processes detected contamination. Oftentimes, however, the contaminated product passed through testing and ended up in the hands of patients and consumers. Outright fraud is certainly a factor. For the most part there is a systemic issue driven by the intersection of a poorly defined testing landscape with poor laboratory practice.
Cannabis testing is extremely complex. The compounds that influence a cannabis product’s properties include a synergistic mix of THC, terpenes, and hundreds of minor cannabinoids. Pesticides, mycotoxins, heavy metals, and other contaminants can enter cannabis products at any point in the supply chain — even incidentally through the gloves workers wear. And the products people buy may be ingested, inhaled, or applied topically, increasing risk.
Laboratories serving other industries can (or must) turn to the Food and Drug Administration’s Current Good Manufacturing Processes (cGMPs) published in the Code of Federal Regulations (CFR) Title 21. These regulations help producers establish risk-based processes to ensure the safety of anything from baby formula to cough drops to prescription drugs.
Federal prohibition means the FDA does not promote cGMPs for medical or recreational cannabis. State regulations are left to pick up the slack, but the guidance can be vague or non-existent in some states and highly prescriptive in others.
We need more accredited laboratories with staff experienced in GLP, ISO, or GMP. Also, implementing a proper quality management system is key to efficiently address all the tasks related to documentations, testing, calibration, training, and so on. ISO/IEC 17025 is written to give an overview for testing and calibration labs; however, it lacks specifics. Figuring how the standards apply on a day-to-day process is something that can only be achieved by staff with the right training and background.
Miguel Fagundes, Cannabis Scientist 4/6/2021
Proving Laboratory Compliance
Accreditation to recognized standards of laboratory best practice can help cannabis testing labs navigate these murky waters – reducing liability while also making them more competitive and viable for the long term. Accreditation processes document the quality management systems (QMS), organizational effectiveness and the reliability of a lab’s testing and calibration processes.
ISO/IEC 17025 is an internationally recognized standard for laboratory best practice that “enables laboratories to demonstrate that they operate competently and generate valid results, thereby promoting confidence in their work both nationally and around the world.”
In many states, compliance with standards is mandatory. California requires its licensed cannabis laboratories to achieve ISO/IEC 17025:2017 accreditation. Oregon has its own requirement based on The NELAC Institute’s National Environmental Laboratory Accreditation Program, itself based on an earlier version of ISO/IEC 17025. Many labs get accredited even if it is not currently required. For example, ISO/IEC 17025 is industry-agnostic and FDA cGMPs apply to broad industry categories, so accreditation helps labs expand their services. And that diversification can help sustain viability in uncertain markets.
CannaQA Facilitates Best Practices
Information management is a key element in achieving any best-practice accreditation. Manually transcribing sample data and test results between labels, paper forms, and various spreadsheets inevitably lead to errors that create bad test results and costly rework. Informal workflows and poorly documented operating procedures work against accuracy, reliability, and consistency.
CannaQA from LabLynx, Inc is a laboratory information management system (LIMS) that is optimized for cannabis testing labs seeking to achieve best-practice accreditations. By consolidating your lab’s data management processes within a central, secure cloud database, you take the first steps towards laboratory quality management.
CannaQA offers many features that aid accreditation including:
- Configuration of Testing Methods and Workflows
- Integration of Instruments and Systems
- Monitoring of Employee Training and Proficiency
- Tracking Samples from Collection to Disposal
- QMS Management
- Auto OOS Alerts
- State-Compliant Report
- More…
Demonstrating your laboratory’s competence is only one benefit of CannaQA. Given the speed with which the market adopts new cannabinoids consumed in new ways, you need a LIMS that lets you respond to changing demands. CannaQA’s easy user-configurability lets you create new methods and workflows quickly without costly development work.
CannaQA also helps with regulatory compliance. The sample and testing data CannaQA stores will automatically populate to appropriate compliance reports and seed-to-sale tracking systems.
LabLynx’s LIMS experts can explain how CannaQA will help your lab’s accreditation efforts and facilitate good laboratory practices. Find out more and ask for a demonstration by visiting cannaqa.com or contacting LabLynx at sales@lablynx.com or 866-LABLYNX (522-5969).
References:
“HSA Issued Re: Retail Marijuana TZ Financial LLC”, Colorado Department of Revenue.
“Bay Mills Marijuana Commission voluntary recalls vape cartridges”, UpNorth Live.
“Cannabis & Chemicals: Why Glove Sourcing is Vital”, Cannabis Industry Journal.
“ISO/IEC 17025 Testing and Calibration Laboratories”, International Organization for Standardization.
“Testing Laboratories”, California Bureau of Cannabis Control.
“Resources for Laboratories Seeking Accreditation for Cannabis Testing”, Oregon State Public Health Laboratory.
“Voluntary Accreditation: Why Labs Seek Accreditation Where it is Not Mandatory”, A2LA.
“Don’t Cross the Streams!”, Cannabis Scientist Magazine.
