Established in 2019, Kelab Analitica is the first laboratory in Colombia to specialize in cannabis and pharmaceutical testing. In March of 2020, the lab began operating and serving the cannabis market in the South American country.
Then in December of 2020, Kelab Analitica obtained ISO/IEC 17025:2017 through Perry Johnson Laboratory Accreditation, making it the very first cannabis testing lab in Colombia to attain accreditation. The lab was also certified shortly after in Good Laboratory Practices by Colombian health authorities for analysis of pharmaceutical products.
The lab has found that ISO 17025 accreditation has helped with their marketing strategy. “As the industry grows, more producers are beginning to understand the importance of working with an accredited laboratory for quality and consistency of results and to comply with international requirements,” says a team member at Kelab Analitica.
In the future, they plan to expand their reach locally in Colombia and look for opportunities to expand in Latin America. They are also engaged in research in chromatography and instrumentation to develop new cannabis testing methods.
ZOSI Analytical, a third-party hemp testing lab based in Georgetown, Texas, announced last week that they have achieved ISO 17025:2017 accreditation from Perry Johnson Laboratory Accreditation (PJLA). ZOSI Analytical is actually the very first hemp lab in Texas to be DEA-registered.
The 2018 Farm Bill has a stipulation for all hemp compliance testing labs to be ISO 17025:2017 accredited by October 2021. ZOSI is a bit ahead of that deadline, but ready to test products for retailers and processors looking to confirm their potency levels below the 0.3% THC federal legal threshold.
According to Amy Lummus, CEO of ZOSI Analytical, they have a turnaround time of about 48-72 hours from receipt of a hemp sample. “Although regulations continue to change at the Federal level and vary widely at State levels, one thing has remained consistent and that has been the understanding that third-party testing laboratories need to show a level of commitment and accountability to quality,” says Lummus. “Our accreditation is one more step in our commitment to helping the industry to produce and sell safe products.”
CannaSafe was allegedly the first to break the news about vaping health issues caused by EVALI, the lung condition responsible for the 2019 vape crisis. According to the press release, they provided testing data that proved black market vapes contained dangerous chemicals, likely including vitamin E acetate, the chemical that the CDC says is linked to EVALI.
CannaSafe say they have plans to expand into a number of states beyond California. They are also planning to build a facility dedicated to CBD testing to meet market needs in the near future.
Since Arizona legalized medical cannabis in 2011 , regulators have not required testing for cannabis products. That is about to change in a little more than a month.
After a long and hard-fought battle by patients and stakeholders in the Arizona cannabis industry, Governor Ducey signed SB1494 into law last year, a bill that requires independent labs to test cannabis products for contaminants. More specifically, the bill requires that cannabis products be tested “to determine unsafe levels of microbial contamination, heavy metals, pesticides, herbicides, fungicides, growth regulators and residual solvents and confirm the potency of the marijuana to be dispensed.”
Ryan Treacy, CEO/Founder of C4 Labs and co-founder of the Arizona Cannabis Laboratory Association (ACLA), has been a vocal advocate for mandatory product safety testing since 2016. After several failed lobbying attempts and forming the ACLA with three other labs in Arizona, SB1494 finally passed in May of 2019.
Under this bill, the Arizona Department of Health Services has been in charge of building the new laboratory regulations. Those rules include certifying and regulating labs, establishing requirements like health and safety protocols, mandatory quality assurance program and standards, chain of custody and sampling policies, adequate records, accreditation, proficiency testing, among other requirements.
In a press release published by Perry Johnson Laboratory Accreditation (PJLA), they announced that C4 Laboratories was accredited to ISO/IEC 17025 this week, in time for the new requirement in Arizona.
According to Treacy, the Department of Health Services is still in the process of finalizing the technical accreditation for labs in the state. He says C4 Labs will be ready to accept compliance samples in the coming weeks. “There will no doubt be a flood of samples and a lot will be asked of the lab operators to continue to build their business to better accommodate sample volume,” says Treacy. They want to minimize any disruption to the supply chain, keeping patients and clients at top of mind.
C4 Labs has been preparing for the flood of compliance testing samples beyond just their accreditation. “Over the last 16 months we have added a new fully renovated lab space, doubled our lab staff and have invested significant monetary resources in additional state of the art analytical instruments to allow for more analysis and expanded lab sample capacity,” says Treacy. “We intend to make efficiency and capacity our focus while maintaining our commitment to sound science and data integrity for our clients and patients alike.”
C4 Labs is currently in its sixth year of operating and was one of the original labs to serve Arizona patients. “We are very proud of the work we have put in to advocate for safe, lab-tested cannabis products and we intend to continue to lead from the front as Arizona’s premier cannabis testing laboratory.”
In a letter sent out to clients last week, Perry Johnson Laboratory Accreditation (PJLA) notified their partner labs that they will be conducting virtual assessments.
PJLA typically conducts assessments on-site. . However, given the current situation, with CDC recommendations for social distancing and mandatory stay-at-home orders in some states, the laboratory accreditation company is pivoting to virtual assessments to help their clients maintain accreditation.
Virtual assessments are not the norm, but they are allowed to offer them during crises where on-site assessments are not possible. PJLA is sending their clients virtual assessment surveys to check the viability of a remote assessment. That includes making sure there’s a video camera in the lab, capability to use remote meeting software, and capability for remote screen sharing during a quality review. Take a look at the letter PJLA sent their clients last week:
Dear PJLA Clients,
Considering the COVID-19 pandemic, business and the conduct of audits has changed dramatically. We at PJLA are doing all we can to maintain accreditation while keeping the health and safety of our auditors, our clients, and their families a priority.
To keep your accreditation valid, we have been able to implement Virtual auditing technology to do entire audits – or at least parts of audits – remotely, using virtual audit techniques. These types of audit are offered for crisis situations where we cannot perform routine on-site assessments (natural disasters, emergencies, travel restrictions).
Clients will be receiving a virtual assessment survey
Allowing for virtual (i.e. cameras in the lab)
Capability to use virtual systems
Having equipment with cameras/remote screen sharing for quality review and laboratory operations
Upon review of the survey, organizations and assessors will be provided with the decision that the assessment can be conducted fully or partially remote. Following approval, assessors and clients will have a discussion to determine the planning of the virtual assessment.
We have a team dedicated to providing support, but we still ask for your patience during this time. It may take some time for everyone to become comfortable with the software. We will be reaching out to each client to hear about their experience to continually improve this process.
We thank you for participating in this new and exciting assessment option.
According to a press release emailed today, Perry Johnson Laboratory Accreditation Inc. (PJLA) announced the accreditation of PharmLabs LLC to ISO/IEC 17025. Based in San Diego, California, PharmLabs has four locations, with three in the Southern California region and one in Maui.
PharmLabs offers a very wide variety of services including: California Compliance testing, a specialized Hemp Testing Program, Hemp Biomass Verification testing, and THC-free testing for the state of California. In addition, they offer the testing of cannabinoids, pesticides, residual solvents, microbiological contaminants, mycotoxins, heavy metals, terpenes, water activity, moisture content, and filth/foreign material testing.
“Our experience with [Perry Johnson Laboratory Accreditation] has been incredible over the years. Since we have multiple locations, we have had many visits with PJLA and their knowledge and quick response time has helped us get where we need to be,” says Greg Magdoff, founder of PharmLabs.
According to the press release, PharmLabs has plans to expand throughout the state of California and the rest of the United States in both hemp and cannabis testing in legal states.
According to a PJLA client spotlight, MML is a female-owned business with two generations of family-run business experience. Before they took the plunge into medical cannabis testing, MML started out testing in public water systems in Montana. They have since expanded their regimen of testing services to offer a host of other services, but most recently adding compliance testing for medical cannabis and cannabis related products.
According to Kimberly Nuccio, president of MML, this accreditation allows them to grow their business considerably. “Accreditation has opened greater opportunities for business growth by attracting larger companies that are looking for reassurance that a laboratory follows the highest testing standards,” says Nuccio. “Being an accredited lab gives them that added confidence necessary when deciding which lab to partner with for their testing needs. Mission Mountain Laboratories is the first Medical Marijuana Lab to achieve ISO accreditation in the state of Montana, and PJLA accreditation helped expand us into the new arena of Medical Marijuana compliance testing.”
MML has plans to expand their operations greatly, including opening a location in Florida by 2020. “We are aware of the increased and urgent demand for quality Cannabis compliance testing nationwide and are currently working on a 3-year plan to expand into Florida and several other states to fill this void,” says Nuccio. “These new locations will also be equipped to provide full service testing for Nutraceuticals, Food manufacturing, and Environmental businesses.”
According to a press release published in December, Digipath Labs, based in Las Vegas, Nevada, was recently accredited to the updated ISO standard, ISO 17025:2017. The laboratory received their accreditation from Perry Johnson Laboratory Accreditation (PJLA).
ISO 17025:2005 has long been the standard that labs seek accreditation to, but their newest 2017 edition was recently rolled out and introduced to the market. The new 2017 standard includes some broad changes to terminology, process approach, scope, and it importantly introduces the concept of risk-based thinking.
That concept of risk-based thinking is particularly relevant to the cannabis testing market, where many have argued for more transparency and uniformity in different state regulations and markets. Introducing risk-based thinking in the standard means that assessors also look at the risk of bias, impartiality and assessing measurement uncertainty, which certainly adds a layer of subjectivity to the accreditation.
Tracy Szerszen, president/operations manager of PJLA, says the newer standard also includes a provision for a quality management system review among other changes. “We are making sure they are following the standard from a technical standpoint, meaning they have the right equipment, the appropriate personnel and also have a quality management system,” says Szerszen. “November 29, 2020 is the deadline for moving to the new 2017 standard.”
According to Todd Denkin, CEO and founder of Digipath, obtaining the new ISO accreditation poises them for future growth and expansion. “Digipath Labs has now brought its standard of excellence in cannabis testing under the updated ISO-17025:2017 umbrella as we seek to expand our dominance in cannabis testing markets,” says Denkin. “This is a major step in positioning Digipath as a global leader in testing services.”
At this year’s Food Safety Consortium a couple weeks ago, the newly launched Cannabis Quality Track featured a number of panels and presentations that highlighted the many intersections between food safety and cannabis. One particular topic of interest was measuring the quality and safety of cannabis products through laboratory testing. At the event this year, representatives from the leading laboratory accreditation bodies in the country sat together on a panel titled Accreditation, Regulation & Certification: Cannabis Labs and Production.
Chris Gunning, life sciences accreditation manager with A2LA
The new ISO 17025:2017 standard was a topic addressed pretty early in the panel. Tracy Szerszen introduced the topic with a recap of the 2005 standard. “With 17025, for those that are familiar with the older version, 2005, there are really two sections of the standard for that one,” says Szerszen. “The newer standard is a little bit different, but there is a quality management system review that we do and we look at the laboratory to ensure that they are testing appropriately based on what they applied for. So, for cannabis labs, they typically have the same scope in types of methods with respect to microbiology and chemistry, and we are making sure they are following the standard from a technical standpoint, meaning they have the right equipment, the appropriate personnel and also have a quality management system.”
Chris Gunning followed that up with a closer look at the changes coming to the new 2017 standard. “If you are familiar with the 2005 version, you know that a lot of the clauses started out with a ‘you shall have a policy and procedure for doing X,’” says Gunning. “One of the major changes to the 2017 version is it gives laboratories more latitude on whether they need to have a policy/procedure to do certain things.” Gunning says the 2017 version is much more of an outcome-based standard. “As far as assessing to it, it becomes a little harder from our side because we can’t say you have to have this quality manual or you have to have this procedure that were going to assess you to. We are more open to looking at the outcomes.”
The most interesting change to the ISO standard comes with addressing the idea of risk. “One of the newest concepts in this standard is risk and how you assess your risk to your organization how you assess risk of impartiality, how you assess your measurement uncertainty when you are creating decision rules,” says Gunning. “Those are the big concepts that have changed in the 2017 standard in that it is more outcome-based and introducing the concept of risk more.”
After discussing some of the broader changes coming to the 2017 version, the panelists began delving into some common pitfalls and issues labs face when trying to get accredited. “From our experience, in Michigan, the new standard was written into the regulations, but a lot of labs were already accredited to 2005,” says Szerszen. “So, we actually contacted the state and explained to them that they have three years to transition. And some states will say ‘too bad, we want the 2017 ISO,’ so some of the cannabis labs are asking us to quickly come back so they can get appropriate licensing in the state and do a transition audit quickly.” She says most states seem to be comfortable with the current transition period everyone has, but it certainly requires some discussion and explanation to get on the same page with state regulators. “November 29, 2020 is the deadline for moving to the new 2017 standard.”
In addition to state requirements like traceability and security on top of an ISO 17025 accreditation, labs can run into issues not typically encountered in other testing markets, as Gunning mentioned during the panel. “One of the hardest parts of getting accredited is the need for properly validated methods, for all the different matrices in samples,” says Gunning. “Some of the biggest hurdles for new labs getting assessed are validation and the availability of reference materials and proficiency testing samples that meet their state requirements.” Those are just a handful of hurdles that labs aren’t usually anticipating when getting accredited.
Another big topic that generated a lot of dialogue during the panel was the need for a national accreditation standard for cannabis testing labs, one that Natalia Larrimer is advocating for. “Many laboratories are operating facilities in more than one state and what they are facing is a different set of criteria for laboratory recognition in each state, says Larrimer. “One initiative that we would love to see more support for, is a set of uniform requirements nationally. ACIL is currently working on developing these type of requirements which would be in addition to the ISO/IEC 17025 standard and specific for cannabis industry…” Larrimer says she’d like to see these requirements recognized nationally to get labs on the same page across multiple states. “This includes requirements for things like security, traceability, proficiency testing, sampling and personnel competence. The industry would greatly benefit from a uniform cannabis testing program across the US, so that testing facilities in Oregon are operating to the same criteria as facilities in California or Colorado, etc.”
The panelists went into greater detail on issues facing the cannabis lab testing industry, but also delved into certifications for food safety and quality, an important new development as the infused products market grows tremendously. Stay tuned for more highlights from this panel and other talks from the Food Safety Consortium. We will be following up this article with another that’ll shed some light on food safety certifications. Stay tuned for more!
The track will have presentations discussing food safety planning in cannabis manufacturing, HACCP, GMPs, regulatory compliance and supply chain issues among other areas. One particular topic of interest in the quality and safety of cannabis products is laboratory testing. At the event this year, leading laboratory accreditation bodies in the country will sit together on a panel titled Accreditation, Regulation & Certification: Cannabis Labs and Production.
Laboratories that are new to the industry and looking to get accredited should be aware of the new ISO/IEC 17025:2017 standard, which was released last year. According to Tracy Szerszen, labs that have already been accredited to the 2005 version will be required to transition to the 2017 version by November 29, 2020. “This can be done in conjunction with routine assessments scheduled in 2019 and 2020,” says Szerszen. “However, laboratories are cautioned to transition within a reasonable timeframe to avoid their 17025: 2005 certificate from lapsing prior to the transition deadline. Some of the changes to the standard include but are not limited to: the re-alignment of clauses similar to ISO 9001:2015 and other ISO industry standards, modifications to reporting and decision rules, the addition of risked based thinking and a new approach to managing complaints.” Szerszen, along with the other panelists, will go much more in-depth on changes to the new ISO 17025 and other topics during the panel at the Food Safety Consortium.
Some of the other topics the panel will discuss include:
ISO/IEC 17025 –what’s expected, benefits of accreditation, common deficiencies, updates to the new 17025 standard
Standards available for production facilities-GMPs & GFSI standards
How standards can be used to safeguard the quality of production and safety requirements
An open discussion with panelists from leading accreditation bodies on the state of cannabis lab testing
According to Chris Gunning, many states are requiring accreditation to ISO/IEC 17025, the standard used throughout the world in many other high-profile industries such as the testing of food and pharmaceuticals, environmental testing, and biosafety testing. “In an industry where there are few standard methods, where one hears that you can ‘pay to play,’ and where there are ‘novice’ laboratories popping up with little experience in operating a testing laboratory, it is extremely important to have an experienced, independent, 3rd party accrediting body evaluating the laboratory,” says Gunning. “This process confirms their adherence to appropriate quality management system standards, standard methods or their own internally developed methods, and can verify that those methods produce valid results. Ultimately, the process of accreditation gives the public confidence that a testing laboratory is meeting their state’s requirements and therefore consumers have access to a quality product.” He says most states with legal cannabis recognize the need for product testing by a credentialed laboratory.
Another important topic that the panel will address is the role of food safety standards in the cannabis industry. Lauren Maloney says cannabis product manufacturers should consider GMP and HACCP certifications for their businesses. “Food safety is important to the cannabis industry because although individual states have mandated several food safety requirements there still considerable risks involved in the production of cannabis products,” says Lauren Maloney. “Consumers want the assurance that the cannabis products are safe and therefore should be treated like a food product. Because FDA does not have oversight of these production facilities, third party certification is essential to ensure these facilities implement a robust food safety system.”
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