A review of the expert strategies and resources to streamline the laboratory accreditation process.
As more states consider the legalization of cannabis for both medical and recreational use, it seems a foregone conclusion that the plant will eventually be reclassified from its current Schedule I status at the federal level. At present, however, with no federal oversight or guidance available, the challenges of regulating this emerging industry fall squarely on the states themselves.
The proliferation of the cannabis industry has spread with such speed that it has outpaced the ability of governing bodies to respond and adapt. This has created a modern-day “wild west” scenario in which some states have strong, well-established protocols in place for governing the industry, while others are in a perpetual state of flux, with regulations and processes changing with the wind. Other states have stalled in the legislative process altogether. In the long run, the wide array of approaches to regulation will likely allow the best ideas from multiple programs to rise to the top and create an industry standard. Until then, the most viable option may be to adopt best practices from testing and calibration laboratories in other industries.
As a result, many states are turning to the International Organization for Standardization (ISO), particularly for cannabis testing laboratories, to standardize their practice. The ISO/IEC 17025:2017 (1) standard (hereafter ISO 17025) enables laboratories to demonstrate that they operate competently and generate valid results, thereby promoting confidence in their work both nationally and around the world.
While ISO 17025 is a familiar standard in the world of testing and calibration as a whole, it is largely new to the cannabis industry. The majority of cannabis laboratories are hiring personnel who are not only new to the industry, but also lack experience operating in a regulated laboratory environment. This often results in a severe underestimation of how challenging ISO 17025 accreditation can be to achieve and how much effort is required to maintain it.
I sat down with Julie Taylor, CEO of Northstar Scientific Solutions, a cannabis analytical laboratory development and consulting firm based in Denver, Colorado and Matthew Sica, Accreditation Manager, RMP, PT, and Medical with ANSI National Accreditation Board (ANAB) with offices in Fort Wayne, Indiana, Alexandria, Virginia, Cary, North Carolina, and Washington, D.C., to learn more about the accreditation process. We also discuss how accreditation compliments good laboratory practice (GLP) and good manufacturing practice (GMP), and how to avoid some of the common pitfalls facing new laboratories pursuing accreditation for the first time.
“Little by little, more of the quality aspect is being brought into the regulation for testing labs. To a degree, even more so than for the consumable products themselves,” said Taylor. “My opinion is that testing labs are being held to a much higher standard than any other players in this industry. I believe that ISO 17025 will become universally mandated sooner than later.”
Some laboratories may be wary of adopting ISO 17025, betting that under the eventuality of the U.S. Food and Drug Administration’s (FDA) regulatory purview, GLP will prevail as the standard of choice. Sica noted, however, that GLP aligns with ISO 17025 and allows for seamless integration. Cannabis laboratories can adopt the standard and then build in GLP requirements, along with any additional state regulations. This is the current approach taken by the construction, environmental, and Department of Defense sectors, among others.
“ANAB has a GLP program with supplemental requirements based on the federal register requirements,” said Sica. “The two really run concurrently. Embracing the ISO 17025 model and building upon that as the core standard with additional specificity is common in many industries, but to totally ignore it seems foolish.”
Both experts agreed that one of the biggest pitfalls for cannabis laboratories pursuing ISO 17025 accreditation is underestimating the challenges in achieving accreditation to the standard and believing it’s a simple process.
“It depends on the lab, but if they have not gone with a consultant, typically there’s a total lack of understanding of accreditation and its requirements,” said Sica. “A lot of times this occurs with investment groups. They hire somebody with a PhD and they whip together a lab. It’s only when their temporary state license is nearing expiration, and they need to get accredited, that they start working on it and find out how big a task it is.”
Taylor agreed. “A lot of what I hear is, ‘as soon as we pass our proficiency testing, we’ll get our accreditation,’” she explained. “But proficiency testing is only a very, very small piece of ISO 17025. It’s not only setting it up, it’s also the ongoing maintenance of the actual accreditation, and by maintenance I mean actually following the processes that you’ve set in place and reviewing them on a regular basis. Continual improvement is a big piece of ISO 17025, so you can’t just set it up and walk away.”
From the beginning, laboratories need to focus on hiring the right personnel—preferably individuals who have experience in a regulated laboratory environment. Currently, an estimated 80% of new hires have no experience in the cannabis sector, and many do not even have a degree in science.
“Look for applicants with a science background who have practical experience in a regulated lab,” Taylor said. “Whether that’s GLP, ISO, or GMP, if they have some sort of experience in a setting like that, then they understand the importance of a quality structure.”
When the laboratory manager and quality personnel don’t understand the complexity of the standard, they tend to underestimate the time, people, and resources required to design their processes and get them up and running, delaying accreditation and subsequent production timelines.
The management of documents alone—including standard operating procedures (SOPs), work instructions, and calibration logs—can create a burdensome workload that has the potential to significantly hobble a lean team of two to four employees trying to get a new laboratory up and running. A software-based quality management system (QMS) can prove invaluable in streamlining this process and creating an efficient method to control documents, manage testing and training records, and automate tedious manual processes like managing equipment logs, calibration schedules, and risk assessments—a major component of ISO 17025. It also allows you to manage your audits and assessments from one central data repository. Qualtrax is one such system, built from the ground up to effectively manage data, streamline the quality system, and simplify the audit process.
- International Standard, 2017, ISO/IEC 17025: General Requirements for the Competence of Testing and Calibration Laboratories.
Tom Borak is a Marketing and Communications Specialist at Qualtrax, Inc., a quality management software provider specializing in accreditation management for organizations facing pressure from a wide range of accreditation and compliance standards. Direct correspondence to: [email protected].
How to Cite This Article
T. Borak, Cannabis Science and Technology 2(5), 71-73 (2019).