Tag Archives: labs

June 28, 2016

The Emerald Test Yields Positive Results for Cannabis Labs

By Aaron G. Biros

Emerald Scientific recently announced results for their latest round of the semi-annual Inter-Laboratory Comparison and Proficiency Test (ILC/PT), and the outcomes may bode well for one of the most vital quality and safety aspects of the cannabis industry. According to Cynthia Ludwig, director of technical services at the American Oil Chemists’ Society (AOCS), there are no official methods for cannabis testing from an internationally recognized non-profit organization known to provide ‘official methods’ to various industries, so method validation needs to be done in-house, which is very costly and time-consuming. Cannabis testing labs are charged with the difficult task of providing honest, consistent and accurate results for potency, pesticide residue, residual solvents and contaminants. AOCS partnered with Emerald Scientific in this round of ILC/PT and preformed the statistical analysis and reports. For the first time in The Emerald Test’s history, participants were able to review all of the raw data and were given a consensus mean, z-scores and kernel density plots in order to compare themselves to other participants.

Emerald Scientific’s ILC/PT program measures how accurately a cannabis lab performs along with comparing it to other labs for an indicator of variability and ways to improve, according to a press release. 46 cannabis laboratories participated in The Emerald Test’s latest round of proficiency testing for potency and residual solvents. Cynthia Ludwig sits on the advisory panel to give direction and industry insights, addressing specific needs for cannabis laboratories. Kirsten Blake, director of sales at Emerald Scientific, believes that proficiency testing is the first step in bringing consistency to cannabis analytics. “The goal is to create some level of industry standards for testing,” says Blake. Participants in the program are given data sets, judged by a consensus mean, so labs can see their score compared to the rest of the cannabis testing industry.

Proficiency tests like The Emerald Test give labs the ability to view how consistent their results are compared to the industry’s results overall. According to Ludwig, the results were pleasantly surprising. “The results were better than expected across the board; the vast majority of labs were within the acceptable range,” says Ludwig. The test is anonymous so individual labs can participate freely. “The overall performance of the participating labs in the Potency and Solvent Residue Emerald Test were very encouraging,” says Ludwig. “All but a couple of labs had the majority of their results fall within two standard deviations of the consensus mean, which is generally accepted as being within the acceptable limits to most evaluators.” Although requirements for labs testing cannabis differ in each state, Ludwig says the results show the ability of these labs to competently perform the tests and generate reliable results. “Given the lack of harmonized regulations, this is a testament to the self-imposed quality standards the industry is trying to achieve.”

Reggie Gaudino, Ph.D., vice president of scientific operations and director of genetics at Steep Hill Laboratories. (photo credit: Preston Gannaway)

Among the laboratories that participated, Steep Hill Laboratories joined the test at two of their locations. Reggie Gaudino, Ph.D., vice president of scientific operations and director of genetics at Steep Hill Laboratories, believes that tests like the Emerald Test ensure that the cannabis labs are performing their function to the best of their ability, which is extraordinarily important. “We, and not just Steep Hill, but all testing labs, are the custodians of quality and safety for the cannabis industry,” says Gaudino. “If we are not doing our best to ensure the quality of our science is beyond reproach, then we are failing the consumer; if even one person gets sick or dies because a lab cut corners and tried to make extra money, that is one person too many.” Accurate testing comes from internal and external proficiency testing.

According to Gaudino, how cannabis labs perform in The Emerald Test can affect every aspect of cannabis consumption: “Correct dosing from potency analysis reports, identification of as many, if not all, active compounds known to enable the consumer to make a determination as to which strain, edible or concentrate would be most beneficial and assurance that there are no harmful chemicals or biological contaminants on cannabis or cannabis derivatives; all of it stems from being able to accurately test.” Gaudino is a major proponent of The Emerald Test because it provides some measure of consistency and accuracy in the cannabis industry. Until more consistent regulations for cannabis testing are formed on a national scale, self-imposed quality standards such as The Emerald Test helps labs, growers and consumers know they are getting reliable data.

June 15, 2016

Documentation & Compliance: A Q&A with Michael Shea, ConformanceWare

By Aaron G. Biros

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Cannabis safety throughout the supply chain requires active documentation tools for business owners to keep up with standards and regulations on the local and state level. Michael Shea, founder and president of AccessQMS and chief executive officer of Upshot’s ConformanceWare, provides consulting support across multiple industries with independent referral services to compliance professionals. With quality, safety and efficiency at top of mind, ConformanceWare’s design team developed the Medical Cannabis Series (MC Series™) to help cannabis business owners make the task of compliance easier. The documentation tools in the program are individually tailored to address needs in cultivation, processing, analyzing and dispensing.

The MC Series-Analyze Edition is currently in use at Canalysis Laboratories and NV Cann Labs, both operating in Nevada. According to Tara Lynn, chief executive officer at NV Cann Labs, the product helps them meet all of their documentation needs. “I appreciate all of the development using the MC Series- Analyze Edition and look forward to developing even more of a relationship through the years to come,” says Lynn. We sit down with Michael Shea to learn more about his product and how cannabis business owners can stay on top of regulatory compliance.

CannabisIndustryJournal: How will the MC Series help cannabis laboratories, cultivators, processors and dispensaries navigate regulatory compliance?

Michael Shea: To open a sustainable business involving cannabis goes beyond submitting applications, paying fees and focusing on profit alone. As laws adjust and tighter controls are put in place, more and more business owners are realizing what preserves and sustains their business is, in fact, compliance.

True sustainability is driven by forward thinking that values documenting and following best practices to ensure quality, safety and efficiency. Ambiguity concerning where to turn or how to correctly produce this documentation not only poses a difficult dilemma, it can put one’s investment at risk as well.

Finding a remedy for the situation begins with an expansion of perspective. Businesses will benefit most by actively working toward compliance from the onset. This approach eliminates having to face non-compliance and the enforcement that goes along with it.

MC Series™ is designed for this purpose and will greatly help businesses precisely document how their method of operation demonstrates full compliance with applicable laws and standards. Each MC Series™ edition is developed using Microsoft Word and Excel, which is then customized to mirror each organization’s processes, procedures and instructions.

Being user friendly, we have built in numerous hyperlinks for navigating and managing files and documents so that the documentation behaves like a website. This enables each user to access, edit, save and retrieve information instantly.

CIJ: How does your product utilize CMC’s, FDA, ISO, FOCUS, AHPA and EPA standards to help business owners?

Michael: Businesses handling cannabis are subject to strict regulations and are expected to show full compliance with regulatory protocols. Setting up your business correctly means playing by the rules and operating with the proper documentation and structural foundation.

By applying established best practices from the start, business owners will be able to minimize risk for investors, tighten efficiencies and quickly adapt to regulatory changes with minor adjustments. This serves two primary functions: Business owners will now have the protection they need and the means to promote their brand as a world-class operation.

Because laws surrounding cannabis are in such a state of flux and revision, what is most valuable to know is what technical documents lawmakers select for the purpose of writing regulations. Putting this knowledge to work, the MC series uses a variety of guidance documents designated by regulatory and standards bodies for best establishing compliance.

Developed with regulations in mind, each series edition accurately defines the scope of applicability required for your business model. Whether you’re a grower, processor, cannabis testing service or dispensary the MC series has a solution. It significantly helps business owners to achieve compliance by providing the required documentation with an operations framework.

MC series merges regulatory best practices with internationally accepted standards to deliver a complete solution with a very quick turnaround time. Designed to ensure public safety and protect human health, the MC series provides a much-needed tool that bridges the gap between compliance and profitability.

CIJ: How might you be ahead of the curve in looking toward a rescheduling or a schedule 2 cannabis framework?

Michael: Being ahead of the curve simply translates to knowing the regulatory landscape and what’s involved moving forward. When the goal is to legalize cannabis for its great many uses and benefits, public health and safety must come first. Now is the time for business owners to get serious and effectively address the process of legitimizing it.

As with anything available for consumption, standardization is the method and regulators have a long established process for putting controls in place to ensure the health and safety of consumers. We have a lot of experience in this area, and our MC Series™ is an exceptionally useful tool for people who don’t. It is our way of contributing to assisting and accelerating the process.

Essentially, we are saying to business owners, operate your business as if cannabis is already legal. Managing your operations in compliance to existing regulatory best practices will speak volumes to lawmakers. You will be effectively demonstrating to Federal and State governments that you understand the importance of regulations to ensure public health and safety and are making compliance top priority.

This will make your business fluid in relation to regulatory changes and prepare you for Schedule II and beyond.

CIJ: Why should business owners be proactive in navigating regulatory compliance with a documentation management system?

Michael: With so many regulations targeting the cannabis industry, it is hard to keep track of and adjust accordingly. Many business owners are getting excited about being involved and making a difference. Amidst all this enthusiasm, the importance of best practices is often times overlooked and prioritized for when business is good and finances improve.

At this point, business owners can no longer afford to position best practices for future use.

For businesses handling cannabis, taking a future stance will always increase risk.. This leaves you legally exposed to unforeseen costs and complications. More importantly, it will exponentially increase the potential for watching your investment, hard work and business be out paced by the competition, or even worse, closed down permanently.

Alternatively, being proactive will yield different results. Great benefits will come by adopting and following best practices to operate your business. In doing so, you now have an effective method to ensure quality, health and safety, environmental stewardship and sustainability. As a rapidly growing industry, these areas of discipline are absolutely critical for cannabis to reach its full potential and be fully accepted.

In many industries, legitimate and successful companies see best practices as simply part of doing business. Many see it as a tool that provides a useful roadmap for continually improving their operations and strengthening their position in the market.

When the legal obligations have been taken care of, success becomes a matter of setting realistic goals, planning well and delivering with impeccable timing. Operational performance can now be measured and improved for unhindered growth. Everyone involved or tied to your business is now on the same page and in areas of supervision, micromanagement is replaced with a documented system. Documentation should clearly define everyone’s roles and responsibilities, so that when errors occur, there are corrective action procedures available to fix them.

Editor’s note: For more information you may reach out directly to Michael Shea at 313-303-6763 or info@conformanceware.com

May 16, 2016

How Potent is Your Product: Getting Educated on Edibles Analysis

By Danielle Mackowsky

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As a result of the rapidly developing cannabis industry, many forensic toxicology labs are looking for fast, reliable and cost-effective methods to determine cannabis potency and pesticide residue in edibles. Although the pros and cons of legalization are still heavily debated throughout the country, all scientists agree that uniform testing policies and procedures need to be established as soon as possible.

Within environmental and food testing laboratories, the use of QuEChERS (Quick, Easy, Cheap, Effective, Rugged, and Safe) has been practiced widely for the past 15 years. In 2003, Dr.’s Michelangelo Anastassiades and Steven Lehotay published the first QuEChERS application, which detailed the determination of pesticide residues in produce. Since then, QuEChERS has become the gold standard for the testing and analysis of a wide variety of edible matrices. United Chemical Technologies (UCT) was the first company to commercialize the product and it became apparent that the application of this technology to cannabis edibles was a natural solution to pesticide residue testing. All of the data from the QuEChERS cannabis edibles pesticide and potency analyses can be found here.

Sample preparation

mixeddropsUCTarticle — Hard candy before freezer mill grinding

Preparation of a sample for QuEChERS analysis varies depending on the type of edible product being tested. Baked goods, chocolate bars and hard candies should be ground into a fine powder prior to analysis. Although this can be achieved using a product such as a SPEX 6770 freezer mill, a blender can suffice when analyzing typical plant-based samples. Liquid samples, such as sodas or teas, should be degassed prior to analysis, whereas any gummy-based candies should be cut into fine pieces. With the exception of the liquid samples, all other matrices should then be hydrated for one hour within a QuEChERS extraction tube.

UCTarticle — Hard candy after freezer mill grinding

Following sample preparation, acetonitrile is added to all samples along with a proprietary blend of QuEChERS extraction salts. These salts remove water from the organic phase, help to facilitate solvent partitioning and protect base-sensitive analytes from degradation. After shaking and centrifuging the sample, three distinct layers are formed. The top layer, which is the organic phase, can then be aliquoted off for further sample clean-up or dilution.

querchersUCTsample — A mint milk chocolate sample after QuEChERS extraction

For pesticide analysis, an aliquot of the organic layer was subjected to dispersive solid phase extraction (dSPE). This process utilizes an additional blend of proprietary sorbents that remove chlorophyll, sugars, organic acids and fatty compounds from the sample. The resulting extract is free of pigmentation and is ready for analysis on the LC-MS/MS. All samples that were analyzed for cannabinoids did not undergo dSPE; rather, a serial dilution was carried out due to the high concentration of cannabinoids in the original organic layer. The original QuEChERS extract required a dilution of 100-200x in order to have a sample that was ultimately suitable for analysis on LC-MS/MS. A UCT Selectra Aqueous C18 HPLC Column and Guard Column were used in a Thermo Scientific Dionex UltiMate 3000 LC System. An aqueous C18 column was selected due to the extreme polarity of the pesticides being analyzed.

Summary

This application utilizes the advantages of UCT’s proprietary QuEChERS combination to extract 35 pesticides and 3 cannabinoids, including tetrahydrocannabinol (THC), cannabidiol (CBD) and cannabinol (CBN) in edibles, followed by either serial dilutions for cannabis potency analysis, or a dSPE cleanup for pesticide residue analysis. This hybrid method allows QuEChERs, which are extensively used in the food testing industry, to be utilized in a forensic setting.

May 4, 2016

AOCS Highlights Cannabis Lab Standards, Extraction Technology

By Aaron G. Biros

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The American Oil Chemists’ Society (AOCS) held its annual conference in Salt Lake City this week, with a track focused on cannabis testing and technology. Cynthia Ludwig, director of technical services at AOCS and member of the advisory panel to The Emerald Test, hosted the two-day event dedicated to all things extraction technology and analytical testing of cannabis.

Highlights in the discussion surrounding extraction technologies for the production of cannabis concentrates included the diversity of concentrate products, solvent selection for different extraction techniques and the need for cleaning validation in extraction equipment. Jerry King, Ph.D., research professor at the University of Arkansas, began the event with a brief history of cannabis processing, describing the physical morphologies in different types of extraction processes.

J. Michael McCutcheon presents a history of cannabis in medicine

Michael McCutcheon, research scientist at Eden Labs, laid out a broad comparison of different extraction techniques and solvents in use currently. “Butane is a great solvent; it’s extremely effective at extracting active compounds from cannabis, but it poses considerable health, safety and environmental concerns largely due to its flammability,” says McCutcheon. He noted it is also very difficult to get USP-grade butane solvents so the quality can be lacking. “As a solvent, supercritical carbon dioxide can be better because it is nontoxic, nonflammable, readily available, inexpensive and much safer.” The major benefit of using supercritical carbon dioxide, according to McCutcheon, is its ability for fine-tuning, allowing the extractor to be more selective and produce a wider range of product types. “By changing the temperature or pressure, we can change the density of the solvent and thus the solubility of the many different compounds in cannabis.” He also noted that, supercritical carbon dioxide exerts tremendous pressure, as compared to hydrocarbon solvents, so the extraction equipment needs to be rated to a higher working pressure and is generally more expensive.

John A. Mackay, Ph.D., left at the podium and Jerry King, Ph.D., on the right

John A. Mackay, Ph.D., senior director of strategic technologies at Waters Corporation, believes that cannabis processors using extraction equipment need to implement cleaning SOPs to prevent contamination. “There is currently nothing in the cannabis industry like the FDA CMC draft for the botanical industry,” says Mackay. “If you are giving a child a high-CBD extract and it was produced in equipment that was previously used for another strain that contains other compounds, such as CBG, CBD or even traces of THC extract, there is a high probability that it will still contain these compounds as well as possibly other contaminants unless it was properly cleaned.” Mackay’s discussion highlighted the importance of safety and health for workers throughout the workflow as well as the end consumer.

Jeffrey Raber, Ph.D., chief executive officer of The Werc Shop, examined different testing methodologies for different applications, including potency analyses with liquid chromatography. His presentation was markedly unique in proposing a solution to the currently inconsistent classification system for cannabis strains. “We really do not know what strains cause what physiological responses,” says Raber. “We need a better classification system based on chemical fingerprints, not on baseless names.” Raber suggests using a chemotaxonomic system to identify physiological responses in strains, noting that terpenes could be the key to these responses.

Cynthia Ludwig welcomes attendees to the event.

Dylan Wilks, chief scientific officer at Orange Photonics, discussed the various needs in sample preparation for a wide range of products. He focused on sample prep and variation for on-site potency analysis, which could give edibles manufacturers crucial quality assurance tools in process control. Susan Audino, Ph.D., chemist and A2LA assessor, echoed Wilks’ concerns over sample collection methods. “Sampling can be the most critical part of the analysis and the sample size needs to be representative of the batch, which is currently a major issue in the cannabis industry,” says Audino. “I believe that the consumer has a right to know that what they are ingesting is safe.” Many seemed to share her sentiment about the current state of the cannabis testing industry. “Inadequate testing is worse than no testing at all and we need to educate the legislators about the importance of consumer safety.”

46 cannabis laboratories participated in The Emerald Test’s latest round of proficiency testing for potency and residual solvents. Cynthia Ludwig sits on the advisory panel to give direction and industry insights, addressing specific needs for cannabis laboratories. Kirsten Blake, director of sales at Emerald Scientific, believes that proficiency testing is the first step in bringing consistency to cannabis analytics. “The goal is to create some level of industry standards for testing,” says Blake. Participants in the program will be given data sets, judged by a consensus mean, so labs can see their score compared to the rest of the cannabis testing industry. Proficiency tests like The Emerald Test give labs the ability to view how consistent their results are compared to the industry’s results overall. According to Ludwig, the results were pleasantly surprising. “The results were better than expected across the board; the vast majority of labs were within the acceptable range,” says Ludwig. The test is anonymous so individual labs can participate freely.

The AOCS cannabis working groups and expert panels are collaborating with Emerald Scientific to provide data analytics reports compliant with ISO 13528. “In the absence of a federal program, we are trying to provide consistency in cannabis testing to protect consumer safety,” says Ludwig. At the AOCS annual meeting, many echoed those concerns of consumer safety, proposing solutions to the current inconsistencies in testing standards.

April 19, 2016

Quality From Canada

Following a Cannabis Sample Through the Lab: 9 Important Steps

By Tegan Adams

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Anytime a cannabis sample enters a laboratory, the sample is received, handled, weighed, identified and traced throughout the testing and disposal process. Laboratories working with cannabis must have quality systems in place to ensure every action taken to test the cannabis sample is documented and in compliance with good manufacturing practices. Eurofins-Experchem’s sample receipt and handling SOPs includes the following key elements.

Purpose: The purpose of the SOP is outlined to make sure it’s outcome is understood
Scope: The Scope of the SOP explains what events the SOP is intended to avoid and which events the SOP is intended to encourage
Responsibilities: All positions that the SOP affects are outlined
Initial Receipt of the Sample: Samples are submitted to Eurofins Experchem Laboratories with a Sample Information Form. In Canada, cannabis is regulated as a controlled substance. Controlled substances come with a special shipping document and must be weighed upon receipt to the lab to make sure the weight is the same as the client has indicated. Cannabis samples received are inspected to ensure no tampering or damage has occurred to the sample before it is tested. Any temperature and/or storage requirements are noted and followed. If any conditions are not understood the client is contacted for clarification immediately. Pending the sample’s conditions are met, the sample is placed into the laboratory.
Procedure: Eurofins Experchem uses its own sample tracking software to track a sample across the lab. A unique project number and date of entry is given to the sample. Client name, product name, condition of sample, test(s) performed, ID or lot number and size of samples are all recorded. A sticker is attached to the sample to clarify.
Rush Samples: Rush samples are stamped “RUSH” in red and are placed in a priority sequence. The sample is placed in the safe until required for testing. If the product is not cannabis, the sample is placed on a shelf corresponding with the actual day of the month it was received and entered into sample tracking. If the sample requires cold temperatures it is placed in a refrigerated area and monitored in a similar way.
Discrepancies: Any discrepancies in information found on the sample that may differentiate from what the client requests will be communicated to the client upon finding.
Controlled Documents: Stickers, original lab specification sheets, sample submission forms, and SOP training evaluation questionnaires.
Results: As soon as testing is completed, lab results are approved by quality assurance reviewers. A Certificate of Analysis (COA) is electronically and automatically sent through the sample tracking system to the client’s email.

April 4, 2016

The Practical Chemist

Easy Ways to Generate Scientifically Sound Data

By Amanda Rigdon

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I have been working with the chemical analysis side of the cannabis industry for about six years, and I have seen tremendous scientific growth on the part of cannabis labs over that time. Based on conversations with labs and the presentations and forums held at cannabis analytical conferences, I have seen the cannabis analytical industry move from asking, “how do we do this analysis?” to asking “how do we do this analysis right?” This change of focus represents a milestone in the cannabis industry; it means the industry is growing up. Growing up is not always easy, and that is being reflected now in a new focus on understanding and addressing key issues such as pesticides in cannabis products, and asking important questions about how regulation of cannabis labs will occur.

While sometimes painful, growth is always good. To support this evolution, we are now focusing on the contribution that laboratories make to the safety of the cannabis consumer through the generation of quality data. Much of this focus has been on ensuring scientifically sound data through regulation. But Restek is neither a regulatory nor an accrediting body. Restek is dedicated to helping analytical chemists in all industries and regulatory environments produce scientifically sound data through education, technical support and expert advice regarding instrumentation and supplies. I have the privilege of supporting the cannabis analytical testing industry with this goal in mind, which is why I decided to write a regular column detailing simple ways analytical laboratories can improve the quality of their chromatographic data right now, in ways that are easy to implement and are cost effective.

Anyone with an instrument can perform chromatographic analysis and generate data. Even though results are generated, these results may not be valid. At the cannabis industry’s current state, no burden of proof is placed on the analytical laboratory regarding the validity of its results, and there are few gatekeepers between those results and the consumer who is making decisions based on them. Even though some chromatographic instruments are super fancy and expensive, the fact is that every chromatographic instrument – regardless of whether it costs ten thousand or a million dollars – is designed to spit out a number. It is up to the chemist to ensure that number is valid.

In the first couple of paragraphs of this article, I used terms to describe ‘good’ data like ‘scientifically-sound’ or ‘quality’, but at the end of the day, the definition of ‘good’ data is valid data. If you take the literal meaning, valid data is justifiable, logically correct data. Many of the laboratories I have had the pleasure of working with over the years are genuinely dedicated to the production of valid results, but they also need to minimize costs in order to remain competitive. The good news is that laboratories can generate valid scientific results without breaking the bank.

In each of my future articles, I will focus on one aspect of valid data generation, such as calibration and internal standards, explore it in practical detail and go over how that aspect can be applied to common cannabis analyses. The techniques I will be writing about are applied in many other industries, both regulated and non-regulated, so regardless of where the regulations in your state end up, you can already have a head start on the analytical portion of compliance. That means you have more time to focus on the inevitable paperwork portion of regulatory compliance – lucky you! Stay tuned for my next column on instrument calibration, which is the foundation for producing quality data. I think it will be the start of a really good series and I am looking forward to writing it.

March 23, 2016

Quality From Canada

Quality Training in a GMP Testing Facility: 8 Steps to Get Employees Compliant

By Tegan Adams

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Eurofins-Experchem Laboratories is a Health Canada and FDA-accredited analytical laboratory with a regulatory support division. The laboratory carries out testing for many different sectors including pharmaceuticals, cosmetics, natural health products and medical devices. Starting in 2014, cannabis testing was incorporated into the mix. One reason our results so accurate is due to rigorous staff orientation and training method. Diligent staff training and monitoring is very important for success as a Good Manufacturing Practices (GMP) facility with a Drug Establishment Licence and Narcotics License. So what does that look like on the inside? Saif Al-Dujaili, our quality assurance manager, Sohil Mana, our vice president of operations, and I will provide some guidelines for developing training programs below.

Introductory Session: When any new employee starts an introductory phase, it begins with general admin, a facility tour, policy manual training, govt. legislation overview and health and safety training and orientation (WHIMS and Bill 168) specific to our lab. We record signatures on any pertinent forms for SOPs that the new employee will be using.
Standard Operating Procedures: Any new employee must read all related SOPs and is evaluated on their understanding of them through questionnaires/quizzes. SOPs are written for all equipment, instrumentation or process that is applied in the lab, to ensure consistency across operations.
Laws and Regulations: New employees must be familiar or familiarized with Good Manufacturing Practices and Good Laboratory Practices. Analysts are required to read all sections of the USP pertinent to their role, as decided by the quality manager and/or dept. head and a checklist is recorded on training.
Methods: Different methods are used to test products including Compendium or other published methods with organizations such as the Association of Analytical Communities (AOAC) and the American Chemical Society (ACS). Client Methods and house-developed methods are also used. If there is a change to any method, a change control form must be filled out and documented.
Documentation: Documentation is very important in a GMP lab. All data is recorded in a hard cover bound book and/or approved worksheets. Quality assurance data reviewers are responsible for ensuring all data is being recorded properly.
Sample Management: Employees are trained on sample management related to sample entry, how samples are distributed to analysts, turn-around time, and where finished projects are placed.
Training Forms: Everything an employee learns must be recorded and filed for records. Analysts must follow a training matrix on qualitative and quantitative testing methods. Recurrent training occurs each 3 years or less depending on the position the analyst holds. Any updates on GMPs, new instruments or equipment is ongoing and recorded. Experchem runs “ghost” samples through its laboratory to ensure compliance by employees at any given time. Employees are evaluated on their abilities to comply.
Ongoing Training: Once employees are up and running they also receive monthly training in the lab and an annual GMP training followed by a comprehensive quiz that must be passed for them to continue work.

Interested in learning more about cannabis testing in Canada and the US? Contact Tegan Adams, business development manager with Eurofins at teganadams@eurofins.com.

Editor’s Note: Eurofins-Experchem has helped submit over 150 MMPR applications to Health Canada and continues to work with 10 of the 27 licensed MMPR producers in Canada. Their regulatory affairs division has started working with companies applying to produce and distribute cannabis in those states, which are new to its sale and distribution. They offer services include writing SOPs, training staff and performing mock inspection audits.

March 18, 2016

Cannabis Labs Conference Makes History at Pittcon

By Aaron G. Biros

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Last week’s Pittcon, the world’s leading conference and expo for laboratory science, brought together thousands of laboratory equipment companies, scientists and laboratory professionals in Atlanta. This year’s meeting made history, as it featured Pittcon’s first cannabis conference.

Generating quite a bit of buzz at the show in Atlanta, the inaugural Cannabis Labs Conference brought Pittcon attendees, cannabis industry leaders and scientists together to discuss the changing landscape of cannabis testing, the need for standards and cannabis laboratory methods. The improvement of quality standards, outside industry expertise and noting the industry still has a long way to go were some of the themes that came out of the talks.

Nic Easley, chief executive officer of Comprehensive Cannabis Consulting (3C), delivered the keynote, addressing concerns over consumer safety and lab testing standards in such a fast-paced market. “What we need now are outside industry experts to help guide this industry with standards and proper analytics,” he said. “With increased efficiencies and competition in the cannabis marketplace, our ethics need to be called into question as the industry reaps its profits.”

Other highlights included the sharing of new validation methods. Scott Radcliffe, technical support scientist at Romer Labs, Inc., presented his findings on the validation of immunoassays for the detection of pathogens and mycotoxins in cannabis. Amanda Rigdon, applications chemist at Restek, Inc., also led a discussion on the opportunities and challenges for method validation in the evolving cannabis industry.

Rigdon provided a glimpse into the amount of work it takes for method validation. “You can have all of the regulations in the world but that does not guarantee that you will produce good data,” Rigdon said. “We need good science, which is lacking currently in the industry.”

rigdoncannabislabs — Amanda Rigdon, applications chemist at Restek, leading a talk on method validation

“We need to show proficiency with a standardized method and that comes through full validation which, requires a lot of money, time and work,” Rigdon added. These components of validation include accuracy, precision, recovery, selectivity, specificity and proper instrument calibration. “The bottom line is labs need a method that is reproducible and robust,” she said. Rigdon also shared her data from recent methods validation at a cannabis laboratory in Spokane, Washington.

Next year’s Cannabis Labs Conference is scheduled to take place in Chicago during the week of March 5, 2017. To hear more about the Cannabis Labs Conference, sign up for the CannabisIndustryJournal newsletter.

March 16, 2016

New Cannabis Lab Rules In Oregon Aim to Curb Fraud

By Aaron G. Biros

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The Oregon Health Authority (OHA) recently implemented a set of temporary rules effective through June 28^th of this year with the goal to establish a set of regulations for cannabis testing by October 1^st. An investigation by The Oregonian highlighted some of the previous problems with cannabis testing in the state.

The most impactful rule changes include The NELAC Institute (TNI) mandatory standards for laboratories that the Oregon Environmental Laboratory Accreditation Program (ORELAP) will use to accredit labs. Initial rules in the Oregon medical cannabis program, HB 3460 from 2013, did not specify accreditation rules for cannabis testing.

oganalyticalworkstation — The OG Analytical laboratory in Eugene, Oregon is working to comply with new regulations, including new sample collection rules

ORELAP currently performs accreditation for lab testing under the Clean Air Act, Clean Water Act, Resource Conservation and Recovery Act and the Safe Drinking Water Act. The new cannabis testing rules will give ORELAP the authority to accredit and regulate cannabis labs in the state of Oregon.

Rodger Voelker, Ph.D., laboratory director of OG Analytical in Eugene, OR, believes these rules are monumental in establishing legitimacy in cannabis testing. “These new rules have major repercussions mainly because they require not only getting accreditation, but maintaining it with very strict requirements,” says Voelker. “That also includes procedural guidelines that very carefully outline the quality of laboratory practices and establishes a set of criteria for method validation.”

Roger Voelker — Rodger Voelker, lab director at OG Analytical laboratory

Voelker notes that two of the biggest changes are in quality control and data management. “The documentation they require is very thorough and strict with the idea that any aspect of an analysis can be replicated,” adds Voelker. “This is a real win for us in my opinion because now we have an agency that can issue the appropriate credentials as well as have the authority to make punitive measures.”

The timeline for implementation with temporary rules allows state regulators to work with laboratories to perform accreditation and bring laboratories up to speed. According to Shannon Swantek, ORELAP compliance specialist, products that dispensaries sell in medical and recreational markets are required to be tested under the new rules and in the analyte lists by an ORELAP accredited laboratory, starting on October 1^st.

Swantek’s job is to accredit cannabis labs to the TNI standards, which is essentially very similar to ISO 17025, just with more prescriptive measures and the ability to pair with state agencies to enforce rules after accreditation. “The timeline for accreditation is dependent on how ready the lab is and how compliant they are to the TNI standard already,” says Swantek. “The culture had gotten so fraudulent that the legislature felt Oregon needed some serious, more strict rules in place.”

One of the biggest changes coming to Oregon cannabis testing is the new sampling requirement. “An accredited laboratory employee must take the sample because sampling is where a lack of training or outright fraud is skewing results, which occurs when a grower brings in a sample not representative of the batch,” adds Swantek. Sample preparation methods will also be required to be more robust to meet the action limits of pesticide testing in particular, helping to identify lower levels like parts-per-billion, according to Swantek.

Reports were also lacking key information in the past. The new rules will require more information such as the procedure used, the analyst carrying it out, dilution factors and any other information you need to theoretically reproduce the result. This will result in more accurate labels on products.

Many are concerned that the new lab testing requirements will raise the price of testing too much. In reality, those current prices are not realistic for accurate data, which points to the rampant fraud that ORELAP is trying to eradicate. “The old rules were written in such an ambiguous way that the prices were set by laboratories without a proper quality program or even without proper instrumentation,” says Swantek.

oganalyticalsign — OG Analytical had to close its doors briefly to meet accreditation

The accreditation process will require particularly robust quality control systems in labs. “Accreditation to the TNI Standard means that lab quality systems will require a documentation system, training procedures, record keeping, personnel requirements, organization details, proof of no conflicts of interest and corrective actions if noncompliant,” adds Swantek. “We single out each method or procedure, look at their raw data and proficiency testing and determine if they are meeting the technical requirements.”

According to Voelker, other industries have learned to adjust their costs with stringent lab testing rules. “I get that no one wants to pay more for lab testing, but the reality is that joining the world of commodities comes with additional costs to ensure consumer safety,” says Voelker. These rule changes will undoubtedly bring more consistency to Oregon’s cannabis industry with accurate lab testing and help the OHA shed more light on issues surrounding consumer safety.

March 14, 2016

A2LA Accredits First Cannabis Laboratory to ISO/IEC 17025

By Aaron G. Biros

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Frederick, MD– The American Association for Laboratory Accreditation (A2LA) completed its first cannabis testing accreditation for Legend Technical Services, Inc., based in St. Paul, Minnesota. A2LA assessed the laboratory to ISO/IEC 17025 which include the general requirements for the competence of testing and calibration laboratories. The laboratory is now able to test medical cannabis in compliance with Minnesota’s Medical Cannabis Registry Program.

The American Assocation for Laboratory Accreditation (A2LA)

Their scope of accreditation (certificate 2950.01) will include testing for cannabinoid potency and profile, terpenes, pesticides, residual solvents, Mycotoxins, heavy metals and analyzing aerobic bacteria, yeast and mold, E. coli, Salmonella and gram-negative bacteria in medical cannabis products.

Roger Brauninger, biosafety program manager at A2LA

According to Roger Brauninger, biosafety program manager at A2LA, this bodes well for cannabis laboratory standards in the future. “We are pleased to provide accreditation to cannabis testing laboratories and recognize the potential international standards have to help ensure safety of all legal products entering the marketplace,” says Brauninger. “Legend Technical Services, Inc.’s accreditation with A2LA recognizes their commitment to providing the highest quality laboratory services and confidence in the safety of cannabis products that they test.”

A2LA’s cannabis accreditation program aims to establish a set of standards for quality in testing for cannabis edibles, concentrates and flower. Many states where cannabis is legal require ISO/IEC 17025 for cannabis laboratories as a baseline standard.