Tag Archives: laboratories

July 28, 2021

Pesticide Remediation by CPC

By Arpad Konczol, PhD

Like any other natural product, the biomass of legal cannabis can be contaminated by several toxic agents such as heavy metals, organic solvents, microbes and pesticides, which significantly influence the safety of the end products.

Let’s just consider the toxicological effects. Since cannabis products are not only administered in edible forms but also smoked and inhaled, unlike most agricultural products, pesticide residue poses an unpredictable risk to consumers. One example is the potential role of myclobutanil in the vape crisis.

Unfortunately, federal and state laws are still conflicted on cannabis-related pesticides. Currently, only ten pesticide products have been registered specifically for hemp by the U.S. Environmental Protection Agency. So, the question arises what has to be done with all pf the high-value, but also contaminated cannabis, keeping in mind that during the extraction processes, not only the phytocannabinoids get concentrated but the pesticides as well, reaching concentrations up to tens or hundreds of parts per million!

Currently, there are three different sets of rules in place in the regulatory areas of Oregon, California and Canada. These regulations detail which pesticides need to be monitored and remediated if a certain limit for each is reached. Because the most extensive and strict regulations are found in Canada, RotaChrom used its regulations as reference in their case study.

To illustrate that reality sometimes goes beyond our imagination, we evaluated the testing results of a THC distillate sample of one of our clients. This sample contained 9 (!) pesticides, of which six levels exceeded the corresponding action limits. The most frightening, however, regarding this sample, is that it contained a huge amount of carbofuran, a category I substance. It is better not to think of the potential toxicological hazard of this material…

The CPC-based purification of CBD is a well-known and straightforward methodology. As the elution profile on the CPC chromatogram of a distillate shows, major and minor cannabinoids can be easily separated from CBD. At RotaChrom, this method has been implemented at industrial-scale in a cost effective and high throughput fashion. In any case, the question arises: where are the pesticides on this chromatogram? To answer this, we set ourselves the goal to fully characterize the pesticide removing capability of our methodologies.

Our results on this topic received an award at the prestigious PREP Conference in 2019. The ease of pesticides removal depends on the desired Compound of Interest.

Here is a quick recap on key functionalities of the partition chromatography.

Separation occurs between two immiscible liquid phases.
The stationary phase is immobilized inside the rotor by a strong centrifugal force.
The mobile phase containing the sample to be purified is fed under pressure into the rotor and pumped through the stationary phase in the form of tiny droplets (percolation).
The chromatographic column in CPC is the rotor: cells interconnected in a series of ducts attached to a large rotor
Simple mechanism: difference in partition

Let’s get into the chemistry a bit:

The partition coefficient is the ratio of concentrations of a compound in a mixture of two immiscible solvents at equilibrium. This ratio is therefore a comparison of the solubilities of the solute in these two liquid phases.

The CPC chromatogram demonstrates the separation of Compounds of Interest based on their unique partition coefficients achieved through a centrifugal partition chromatography system.

CPC can be effectively used for pesticide removal. About 78% of the pesticides around CBD are very easy to remove, which you can see here:

In this illustration, pesticides are in ascending order of K_d from left to right. CBD, marked with blue, elutes in the middle of the chromatogram. The chart illustrates that most polar and most apolar pesticides were easily removed beside CBD. However, some compounds were in coelution with CBD (denoted as “problematic”), and some compounds showed irregular K_d-retention behavior (denoted as “outliers”).

If pesticides need to be removed as part of THC purification, then the pesticides that were problematic around CBD would be easier to remove and some of the easy ones would become problematic.

To simulate real-world production scenarios, an overloading study with CBD was performed, which you can see in the graph:

It is easy to see on the chromatogram that due to the increased concentration injected onto the rotor, the peak of CBD became fronting and the apparent retention shifted to the right. This means that pesticides with higher retention than CBD are more prone to coelution if extreme loading is applied.

To be able to eliminate problematic pesticides without changing the components of the solvent system, which is a typical industrial scenario, the so-called “sweet spot approach” was tested. The general rule of thumb for this approach is that the highest resolution of a given CPC system can be exploited if the K_d value of the target compounds fall in the range of 0.5-2.0. In our case, to get appropriate Kd values for problematic pesticides, the volume ratio of methanol and water was fine-tuned. Ascending mode was used instead of descending mode. For the polar subset of problematic pesticides, this simple modification resulted in an elution profile with significantly improved resolution, however, some coelution still remained.

In the case of apolar pesticides, the less polar solvent system with decreased water content in ascending mode provided satisfactory separation.

Moreover, if we focus on this subset in the three relevant regulatory areas, the outcome is even more favorable. For example, myclobutanil and bifenazate, dominant in all of the three regulatory regions, are fully removable in only one run of the CPC platform.

Based on these results, a generic strategy was created. The workflow starts with a reliable and precise pesticide contamination profile of the cannabis sample, then, if it does not appear to indicate problematic impurity, the material can be purified by the baseline method. However, if coeluting pesticides are present in the input sample, there are two options. First, adjusting the fraction collection of the critical pesticide can be eliminated, however the yield will be compromised in this case. Alternatively, by fine-tuning the solvent system, a second or even a third run of the CPC can solve the problem ultimately. Let me add here, that a third approach, i.e., switching to another solvent system to gain selectivity for problematic pesticides is also feasible in some cases.

In review, RotaChrom has conducted extensive research to analyze the list of pesticides according to the most stringent Canadian requirements. We have found that pesticides can be separated from CBD by utilizing our CPC platform. Most of these pesticides are relatively easy to remove, but RotaChrom has an efficient solution for the problematic pesticides. The methods used at RotaChrom can be easily extended to other input materials and target compounds (e.g., THC, CBG).

July 27, 2021

The Importance of Understanding Cannabis Testing Results

By Josh Reed

2 Comments

Cannabis testing is important for both operators and consumers, but there are some differences in what is important to each group. Obviously, safety and efficacy are important to both. Cannabis is primarily tested for safety reasons to ensure that consumers are receiving a product that is safe to consume and accurately labeled. In addition, consumers may look for a potency they’re used to consuming or a certain terpene profile that gives them a desired effect. Cannabis operators, on the other hand, use testing results to improve their processes and to monitor product quality versus state specific regulatory requirements that could cause their products to pass or fail.

What cannabis operators need to understand about cannabis testing results

Historically, there was an education gap on the side of the operators when it came to interpreting results. The regulated cannabis industry is still quite new and cannabis operators were initially focused on getting products to market. While there was always a focus on regulatory compliance and safety, the same level of quality control that existed in other regulated industries like food production seemed to lag. That has changed as operators have become more sophisticated and are hiring experts skilled in interpreting results and quality control. For a laboratory, hiring scientists with a regulatory background offers the operators the experience needed to ensure they’re getting accurate results that are easy to understand. This has led to more meaningful collaboration between labs and operators who work together to understand what test results mean to their processes and business operations.

OGanalytical instruments. — Consumers can easily grasp high level results in the form of charts and graphs

A common problem is that some operators see testing as just a speed bump. This doesn’t have to be the case. Third-party testing is an integral part of getting safe products to consumers. Businesses need to find a lab that understands their objectives and knows how to support the manufacturing and production cycles. Establishing a testing protocol with a lab will help ensure that there are no surprises and that products can be tested and sold as quickly as possible.

Now that operators and labs are speaking the same language, the challenge becomes translating that information into a consumer-friendly format. Consumers don’t necessarily need (or want) to explore the minutiae of every tested analyte, but they can easily grasp high level results in the form of charts and graphs. Translating the testing results into an easy-to-digest format allows consumers to better understand the products they are buying.

What are the main components of test results cannabis businesses should look for?

The first and most obvious results to look for is what was tested and if any tests delivered a failing result. A failing result is determined by comparing the tested values against the state requirements. If a product has failed testing in any area, operators will need to work with the lab and their internal teams to determine exactly what the issue is and if it can be rectified. Failing of any state required test (pesticide, microbial, metals, ….) means the product cannot be sold in its current form. Depending on the state, failing results may be required to be confirmed by another lab, processed further to remove the failing contaminants or destroyed. The production cycle to grow, process and manufacture cannabis products can take anywhere from 120 to 160 days with many different processes and handlers. Despite attempts to control all the variables that impact final product quality, failing tests do occur.

EVIO labs photo — Despite attempts to control all the variables that impact final product quality, failing tests do occur.

Once businesses have passed the state-required testing, the remaining tests are focused on product characteristics including potency and terpene profile. The potency of a product measures the levels of cannabinoids and influences both production and marketing decisions. Lower potency flower may be extracted for distillate products while higher potency flower will demand a higher price and will most likely be sold as flower or processed into concentrate products. Cannabinoid profiles go well beyond just CBD and THC. Understanding the full cannabinoid profile of a product is an important factor in how it can be marketed, and how it will be used.

The terpene profile of a product is also quickly becoming just as important to medical and adult use consumers. Terpenes play a major role in the effects that consumers experience with cannabis products. In the past, consumers relied heavily on strain names to purchase products that they believed would give them the effects that they were looking to achieve. Moving forward, we believe that consumers will be more interested in a product’s terpene profile given the strong influence that terpenes have on effects. In states like Nevada, cannabis businesses put terpene profiles on their product labels and cannabis consumers are starting to select products based on terpenes rather than raw potency numbers.

What is the most important factor in cannabis testing results?

Trust is the most important factor when testing cannabis. Operators need to trust that their lab is providing consistent, accurate and timely results. Consumers need to be able to trust what they read on the certificate of analysis, and they ultimately need to trust that the products they buy will deliver the effects that they expect.

The easiest way for businesses to increase trust in their products and testing results is transparency. When there is transparency from the testing lab to the business and customers, it will help build trust and establish a brand for the long term.

Another important aspect of this process is ensuring businesses share the right information with consumers and educate them as to what it means to them. Information overload, without explanation, will only lead to confusion. It’s important to educate employees, especially those interfacing with customers, on how to interpret and explain test results in a way that consumers can understand.

It can be challenging to translate highly technical test results into consumer-friendly language but being able to do so will enable businesses to build a stronger relationship with customers. This isn’t something that businesses need to figure out by themselves. Rely on your trusted lab partners to help design and deliver easy to understand, consumer friendly certificates of analysis. Consumers want to be educated and understand what is in their products, and how the products will work for them. Trust, transparency and education will help cannabis operators strengthen relationships and continue to grow their business.

July 22, 2021

Quality Systems 101: CAPA Programs Drive Improvement & Prevent Costly Mistakes

By David Vaillencourt

No Comments

No business is perfect, especially when humans are part of the equation. But, how do you tackle fixing quality issues as they arise? The goal of this article is to shed some light on the value of a CAPA program and why many states are making them mandatory for cannabis businesses.

Let’s consider the following situations:

Analytical lab results for a production batch test above the limit for a banned pesticide or microbial contamination
You open a case of tincture bottles and some are broken
A customer returns a vape pen because it is leaking or ‘just doesn’t work’

Do you…

Document the issue?
Perform some sort of an investigation, asking questions of the people involved?
Ask for a retest? Then, if the test comes back positive, move on?

Let’s go through each one of these and understand why the suboptimal answer could be costing your business money:

You don’t document the issue

I hear excuses for skipping on documentation all the time.

“It’s not a big deal”
“It was a one off”
“The glasses probably broke in transit”
“They are cheap and easily replaceable”
“It’s not worth the time”

Tracking and documenting supplier shipments can help you identify supply chain issues.

In the situation of a couple of broken bottles in a shipment, what if it was the seventh time in the last two months? If you haven’t been documenting and tracking the issue, you have no way of knowing if it was a single occurrence. Remember when you were surprised that your filling team did not have enough bottles? Those broken bottles add up. Without documenting the incident, you will never know if it was truly a one-time mistake or the sign of a deeper issue. The reality is, it could be sloppy handling on the production line, issues with the shipper or even a sign of poor quality coming from the supplier.

Have you ever compared the number of fills vs the number of bottles ordered? How much money have you already lost due to those broken bottles adding up? Do you have the ability to answer this question?

You perform an investigation

Let’s say a customer returns a leaky vape pen. You perform an investigation by asking the production workers what they think went wrong. They say that it’s very difficult to get the seal for the cartridge into place. Their supervisor tells them to try harder, refunds the customer and moves on. But, why is it difficult to get the seal into place? Is it a design flaw? Should a special tool be used to assemble the cartridge properly? Without getting to the root cause of why the seals are leading to leaking cartridges, you are doomed to have repeat issues. Numerous studies have found that less than one in twenty dissatisfied customers will complain, and that approximately one in ten will simply leave for another brand or provider. How much is this unresolved issue truly costing your business?

Asking for a retest and if it passes, releasing the product and moving on.

Suppose a major producer of cereal received test results for its most popular cereal that were positive for levels of heavy metals that research has shown to be linked to cancer or developmental issues in children. Now, suppose the company stated that it was an isolated incident and a retest showed that the product met acceptable limits. Further investigation showed no paperwork, save for a couple of emails and a phone call between the lab and the producer. Would that give you peace of mind? This is known as “testing into compliance” and was the subject of a landmark lawsuit in 1993 that Barr Laboratories lost.

For many the answer would be a hard NO. But this happens every day. In Colorado, 12.5% of cannabis batches failed final product testing in 2018 and 2019. That’s one in eight batches! What happened to those products? Good question.

Enter: CAPA (Corrective Action and Preventive Action) programs! For people with a background in quality and GMPs (Good Manufacturing Practices), CAPA is a household name. And, it’s quickly becoming a requirement that cannabis regulatory bodies are looking at. Colorado was the first state to explicitly require CAPA programs for all license holders effective January of this year and has provided a free resource for them. But, for the large majority of people, including those in the cannabis industry, it’s just another acronym.

What does a CAPA program do?

The benefits are numerous but two major ones are:

An effective tool for investigating the true root cause

First of all, a CAPA program provides the framework for a tool for investigation – as Murphy’s Law posits – things go wrong all of the time. Whether you have a manual, labor-intensive process or a highly automated operation, the equipment is programmed, maintained and monitored by humans. The logical sequence of problem solving within a CAPA program allows you to thoroughly investigate and determine the root cause of the issue. With a complete understanding of root cause, you are then able to eliminate it and prevent future occurrences – not just in the one area investigated, but in all similar situations throughout the company.

System for continuous improvement

Gathering info from a customer complaint like batch or product IDs can be crucial in a CAPA system

Anyone who is in the market for a new car lately can appreciate the technological advances. In the 1980s, it was air bags and ABS brakes (those of you that drive in snowy climates and remember having to pump your brakes can appreciate technological advancements). Bluetooth technology for hands-free communication and radio control is another example of continuous improvement in cars.

This is one of the biggest predictors and differentiators between profitable and successful companies with satisfied clients and one that is barely scraping by. The cost of poor quality adds up!

Key inputs in a CAPA system

If the output is an improved system and lower cost of quality, we need to make sure we’re considering the potential inputs.

Information that feeds into your CAPA system:

Customer complaints

Every complaint must be recorded. Gather as much information as possible, but at a minimum: the product type/SKU, the customer name and date of purchase. If possible, the batch or product ID.

This is not necessarily to identify products for a recall, but to prevent…

Laboratory test results

This should not be restricted to final product testing, but include any in-process inspections. Say you have a product repeatedly failing final testing, what if it’s actually been consistently failing or very close to failing at the very first in-process inspection? It’s also important to work with your laboratory to understand their method validation process, including the accuracy, precision, robustness, etc.

Infrastructure & environmental controls/monitoring

Most people consider “environmental controls” to be things like temperature and humidity control. While that is true, it can also include pest and contamination control. Poorly designed infrastructure layouts are major contributors to product cross contamination as well.

Supplier information

Undetected supply chain issues (remember the broken bottles?) can add up fast! CAPAs for suppliers cannot just include supplier monitoring, but improvement in how you communicate your needs to your suppliers. It’s easy to overlook non-cannabis raw materials as sources of microbiological and chemical contamination. Conduct a risk assessment based on the type of contact with your product and the types of contamination possible and adjust your supplier qualification program accordingly.

Are you ready to recognize the benefits of a CAPA program?

One more major benefit of CAPA programs to mention before we go is … Preventive via predictive analytics.

In Colorado, 15% of the final tested cannabis flower products continue to fail, mostly due to mold and mildew. A quality system, with effective data capture that is funneled into a CAPA program can easily reduce this by 75%. For even a small business doing $2M per year in revenue, that equates to a revenue increase of nearly $200,000 with no additional expenses.

Whether you are operating in the State of Colorado or elsewhere, a CAPA and Recall program will provide immense value. In the best case, it will uncover systemic issues; worst case, it forces you to fix mild errors. What are you waiting for?

July 20, 2021

Mark Your Calendars: Upcoming Webinar on Pesticide Testing

By Cannabis Industry Journal Staff

No Comments

Cannabis Industry Journal is hosting a complimentary webinar on August 25 at 12 Noon EDT. The webinar is titled “Improving Cannabis Pesticide Testing via Cloud-Based Saas Software & Automation Technology” and is sponsored by Perkin Elmer.

Attendees registering for this complimentary webinar will see Toby Astill, Ph.D., cannabis testing expert and global market manager for Cannabis & Hemp at PerkinElmer present on pesticide testing and automation. He is available for a live Q&A at the end of the event. In addition to getting the opportunity to chat with Toby Astill on August 25, a recording of the presentation will be made available to all who register.

This virtual event will help attendees better understand how an innovative automation hardware and software workflow allows cannabis & CBD laboratories to complete their pesticide and mycotoxin assays more efficiently and confidently.

Data will be presented to show the workflow suitability for cannabis flower, the benefit of adding an autonomous sample preparation platform and software solutions to integrate multiple data streams into one compliance framework. References will show that having a validatable protocol and SOP for the cannabis testing industry is key in ensuring the highest quality of cannabis reaches the consumer.

To learn more, click here to see the agenda and register.

June 30, 2021

Ask the Experts: Microbiological Contamination in Cannabis & What You Should Look for

By Cannabis Industry Journal Staff

4 Comments

Testing cannabis and cannabis derived products for microbiological contamination should be a straightforward conversation for testing labs and producers. However, a patchwork of regulations and a wide variety of perspectives on what we should, or should not, be looking for has left much of the cannabis industry searching for reliable answers.

Organizations like the AOAC are taking the first crack at creating standardization in the field but there is still a long way to go. In this conversation, we would like to discuss the general requirements that almost all states share and where we see the industry headed as jurisdictions start to conform to the recommendations of national organizations like AOAC.

We sat down with Anna Klavins and Jessa Youngblood, two cannabis testing experts at Hardy Diagnostics, to get their thoughts on microbiology testing in the current state of the cannabis industry.

Q: What are the biggest challenges facing cannabis testing labs when it comes to microbiology?

The CompactDry Yeast and Mold Rapid plate provides fast results.

Anna Klavins & Jessa Youngblood: For microbiology testing, it comes down to a lack of standardization and approved methods for cannabis. In the US, cannabis regulation is written on a state-by-state level. As a result, the rules that govern every aspect of bringing these materials to market is as unique and varied as the jurisdiction writing them. When we are speaking specifically about microbiology, the question always comes back to yeast and mold testing. For some, the challenge will often be centered on the four main Aspergillus species of concern – A. terreus, A. niger, A. fumigatus, and A. flavus. For others, it will be the challenges of total count testing with yeast, mold, and bacteria. These issues become even more troublesome by the lack of recognized standard methodology. Typically, we expect the FDA, USP, or some other agency to provide the guidelines for industry – the rules that define what is safe for consumption. Without federal guidance, however, we are often in a situation where labs are required to figure out how to perform these tests on their own. This becomes a very real hurdle for many programs.

Q: Why is it important to use two different technologies to achieve confirmation?

Dichloran Rose Bengal Chloramphenicol (DRBC) Agar is recommended for the enumeration of yeasts and molds.

Klavins & Youngblood: The push for this approach was borne out of the discussions happening within the industry. Scientists and specialists from across disciplines started getting together and creating groups to start to hash out problems which had arisen due to a lack of standardization. In regards to cannabis testing, implementing a single method for obtaining microbiology results could be unreliable. When clients compared results across labs, the inconsistencies became even more problematic and began to erode trust in the industry. As groups discussed the best way to prove the efficacy of their testing protocol, it quickly became apparent that relying on a single testing method was going to be inadequate. When labs use two different technologies for microbiology testing, they are able to eliminate the likelihood of false positives or false negatives, whichever the case may be. In essence, the cannabis testing laboratories would be best off looking into algorithms of detecting organisms of interest. This is the type of laboratory testing modeled in other industries and these models are starting make their way into the cannabis testing space. This approach is common in many food and pharma applications and makes sense for the fledgling cannabis market as well.

About Anna Klavins

Anna Klavins earned a Molecular and Cellular Biology B.S. degree from Cal Poly San Luis Obispo while playing for the Cal Poly Division I NCAA women’s tennis team. Since joining Hardy Diagnostics in mid-2016, she has gained experience in FDA submissions [510(k)] for class II microbiology in vitro devices. She has worked on 15 projects which led to a microbiology device becoming FDA cleared. She has recently begun participating in the AOAC Performance Tested Methods program.

About Jessa Youngblood

Jessa Youngblood is the Food, Beverage and Cannabis Market Coordinator for Hardy Diagnostics. A specialist in the field of cannabis microbiology for regulatory compliance, she is seated with the AOAC CASP committee working on standard methods for microbiological testing in cannabis and hemp. She also sits on the NCIA Scientific Advisory Council as well as the ASTM Cannabis Council.

Content sponsored by Hardy Diagnostics.

June 16, 2021

SC Labs Develops Comprehensive Hemp Testing Panel

By Cannabis Industry Journal Staff

No Comments

SC Labs, a cannabis testing company with roots in Santa Cruz, California, announced this week that they have developed a comprehensive hemp testing panel that covers a number of contaminants on a national regulatory level. In the press release, the company says they aim to fill the void of national hemp testing requirements.

The hemp testing panel they have developed purportedly meets testing standards in states that require contaminant levels below a certain action limit. The SC Labs hemp testing panel could theoretically be used for regulatory compliance testing across the country, reaching action limits and analyte levels that meet the strictest state requirements.

The panel tests for pesticides, heavy metals, microbiology, mycotoxins, residual solvents and water activity.

The panel is one sign of progress on the long road to nationally harmonized testing standards. “As an industry, we’ve been advocating for national, standardized, and transparent testing regulations for years now,” says Jeff Gray, CEO of SC Labs. “The government has been slow to respond so we decided it was time to act. As an industry, we’ve been advocating for national, standardized, and transparent testing regulations for years now. The government has been slow to respond so we decided it was time to act.”

SC Labs is headquartered in Santa Cruz, but has licenses in California, Oregon, Texas and Colorado (pending). Their California and Oregon locations are both ISO 17025-accredited and conducting THC-containing cannabis testing, as well as hemp testing.

June 9, 2021

How Effective is Your Internal Auditing Program?

By David Vaillencourt

No Comments

The word “audit” evokes various emotions depending on your role in an organization and the context of the audit. While most are familiar with and loathe the IRS’s potential for a tax audit, the audits we are going to discuss today are (or should be) welcomed – proactive internal quality audits. A softer term that is also acceptable is “self-assessment.” These are independent assessments conducted to determine how effective an organization’s risk management, processes and general governance is.

“How do you know where you’re going if you don’t know where you’ve been” – Maya Angelou

Internal quality audits are critical to ensuring the safety of products, workers, consumers and the environment. When planned and performed periodically, these audits provide credible, consistent and objective evidence to inform the organization of its risks, weaknesses and opportunities for improvement. Ask yourself the question: do your clients/vendors rely on you to produce reliable, consistent and safe products? Assuming the answer is yes, what confidence do you have, and where is the documented evidence to support it?

Compliance units within cannabis businesses are typically responsible for ensuring a business stays legally compliant with state and federal regulations. This level of minimum compliance is critical to prevent fines and ensure licenses are not revoked. However, compliance audits rarely include fundamental components that leave cannabis operators exposed to many unnecessary risks.

As a producer of medical and adult-use products that are ingested, inhaled or consumed in other forms by our friends, family and neighbors, how can you be sure that these products are produced safely and consistently? Are you confident that the legal requirements mandated by your state cannabis control board are sufficient? Judging by the number of recalls and frustrations voiced by the industry regarding the myriad of regulations, I would bet the answer is no.

What questions do internal audits address? Some examples include:

Are you operating as management intends?
How effective is your system in meeting specified objectives? These objectives could include quality metrics of your products, on-time delivery rates and other client/customer satisfaction metrics.
Are there opportunities to improve?
Are you doing what you say you do (in your SOPs), and do you have the recorded evidence (records) to prove it?
Are you meeting the requirements of all applicable government regulations?

There are potential drawbacks to internal audits. For one, as impartiality is essential in internal audits, it may be challenging to identify an impartial internal auditor in a small operation. If your team always feels like it is in firefighting mode, it may feel like a luxury to take the time to pull members out of their day-to-day duties and disrupt ongoing operations for an audit. Some fear that as internal assessments are meant to be more thorough than external assessments, a laundry list of to-do items may be uncovered due to the audit. But, these self-assessments often uncover issues that have resulted in operational efficiencies in the first place. This resulting “laundry list” then affords a proactive tool to implement corrective actions in an organized manner that can prevent the recurrence of major issues, as well as prevent new issues. The benefits of internal audits outweigh the drawbacks; not to mention, conducting internal audits is required by nearly every globally-recognized program, both voluntary (e.g. ISO 9001 or ASTM Internationals’s Cannabis Certification Program) and government required programs such as 21 CFR 211 for Pharmaceuticals.

Internal Auditing is a catalyst for improving an organization’s effectiveness and efficiency by providing insight and recommendations based on analyses and assessments of data and business processes. Additional benefits of internal audits include giving your organization the means to:

Ensure compliance to the requirements of internal, international and industry standards as well as regulations and customer requirements
Determine the effectiveness of the implemented system in meeting specified objectives (quality, environmental, financial)
Explore opportunities for improvement
Meet statutory and regulatory requirements
Provide feedback to Top Management
Lower the cost of poor quality

Findings from all audits must be addressed. This is typically done in accordance with a CAPA (Corrective Action Preventive Action) program. To many unfamiliar with Quality Management Systems, this may be a new term. As of Jan 1, 2021, this is now a requirement for all cannabis licensed operators in Colorado. Many other states require a CAPA program or similar. Continuing education units (CEUs) are available through ASTM International’s CAPA training program, which was developed specifically for the cannabis industry.

Examples of common audit findings that require CAPAs include:

Calibration – Production and test equipment must be calibrated to ensure they provide accurate and repeatable results.
Document and record control – Documents and records need to be readily accessible but protected from unintended use.
Supplier management – Most standards have various requirements for supplier management that may include auditing suppliers, monitoring supplier performance, only using suppliers certified to specific standards, etc.
Internal audits – Believe it or not, since internal audits are required by many programs, it’s not uncommon to have a finding related to internal audits! Findings from an internal audit can include not conducting audits on schedule, not addressing audit findings or not having a properly qualified internal auditor. Are you looking for more guidance? Last year, members of ASTM International’s D37 Committee on Cannabis approved a Standard Guide for Cannabis and Hemp Operation Compliance Audits, ASTM D8308-21.

If you are still on the fence about the value of an internal audit, given the option of an inspector uncovering a non-conformance or your own team discovering and then correcting it, which would you prefer? With fines easily exceeding $100,000 by many cannabis enforcement units, the answer should be clear. Internal audits are a valuable tool that should not be feared.

June 8, 2021

Kelab Analitica Becomes First Accredited Cannabis Lab in Colombia

By Cannabis Industry Journal Staff

No Comments

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.

May 26, 2021

Bio-Rad Aspergillus PCR Test Gets AOAC Approval

By Cannabis Industry Journal Staff

No Comments

According to a press release published earlier this month, the Bio-Rad iQ-Check Aspergilllus Real-Time PCR Detection Kit has received AOAC International approval. The test covers detection for four different Aspergillus species: A. flavus, A. fumigatus, A. niger, and A. terreus.

The detection kit covers those Aspergillus species for testing in cannabis flower and cannabis concentrates, produced with our without solvents. The PCR detection kit was validated through the AOAC Research Institute’s Performance Tested Method Program. They conducted a study that resulted in “no significant difference” between the PCR detection kit and the reference method.

The kit was evaluated on “robustness, product consistency, stability, inclusivity and exclusivity, and matrix studies,” the press release says. Bio-Rad also received approval and validation on the iQ-Check Free DNA Removal Solution, part of the workflow for testing cannabis flower.

The test kit uses gene amplification and real-time PCR detection. Following enrichment and DNA extraction, the test runs their PCR technology, then runs the CFX Manager IDE software to automatically generate and analyze results.

Bio’Rad has also recently received AOAC approval for other microbial testing methods in cannabis, including their iQ-Check Salmonella II, iQ-Check STEC VirX, and iQ-Check STEC SerO II PCR Detection Kits.

May 18, 2021

Medicinal Genomics Hires Sherman Hom as New Director of Regulatory Affairs

By Cannabis Industry Journal Staff

No Comments

According to a press release published last week, Medicinal Genomics has hired Sherman Hom, Ph.D. to be their first director of regulatory affairs. Dr. Hom is coming from a position at New Jersey’s Division of Public Health and Environmental Laboratories (PHEL) where he was the leading research scientist for the state’s cannabis testing lab as well as coordinating their pre-analytical activities for SARS-CoV-2 testing.

As project manager for the state’s cannabis testing lab, he was responsible for validating microbial testing in cannabis. He has also been a professor of microbiology, a lab manager, a senior research scientist, a writer and an inventor, according to the press release.

“My passion is regulatory affairs,” says Dr. Hom. “For the last 4 years, we’ve been building a facts and comparison database of required state medical cannabis testing. It’s formidable. Of course, the states will all have the same regulations eventually. In the meantime, it’s my job to help them craft the safest, most efficient and effective set of regulations possible. I’m here because I know Medicinal Genomics shares that passion.”