71208_LM_Cannabis_Resource Guide Strategies for quality control and accurate testing HOW TO set up your lab CANNABIS testing regulations CHOOSING chromatography methods Table of Contents 4Setting Up and Running a Cannabis Testing Lab: Key Points toConsider7Navigating Regulations in the Cannabis Industry: Hitting a MovingTarget10Chromatography in Cannabis Testing14Developing a Standard for Cannabis Sample Prep in Quality ControlTesting 2 Lab Manager 16Facing Key Challenges in the Cannabis Testing Industry Introduction Cannabis Testing Overcoming challenges in a unique industry Legal cannabis is a multi-billion dollar market in the United States. In addition to recreational use, tetrahydrocannabinol (THC) is being investigated for a range of medical conditions and therapeutic purposes. Thith widespread consumption, the cannabis testing lab is critical for ensuring safe, effective, and compliant cannabis products. Testing labs may assess potency, safety (via testing for pesticides, heavy metals, and other contaminants), regulatory compli- ance, and more. The unique nature of the cannabis product can pose several challenges for starting and operating a testing lab. Local, state, and federal government regulations vary widely and are a considerable challenge for cannabis testing labs. Federal laws for example may prohibit samples from crossing state lines for testing. Awareness and the ability to adapt to changing regulations are essential for success. The need for specialized equipment and instruments poses another challenge for labs. Can- nabis testing involves quantifying a variety of compounds including cannabinoids, terpenes, pesticides, heavy metals, and more. It is important to work with quality instrument vendors that pair knowledge with good customer service. Used or refurbished equipment can be a more affordable option, but labs should weigh the cost savings against service and reliability, among other factors. A lack of standardized testing methods also has many implications for labs. Thithout stan- dardized methods, inconsistent results can create uncertainty about the accuracy of the data. Further, it becomes difficult to ensure consistent quality assurance practices and to meet regulatory requirements. Labs may also face higher costs (money and time) to develop and validate methods. As organizations develop requirements to supplement the ISO/IEC 17025 that specifies requirements for competence of testing and calibration laboratories, labs can expect operating costs and testing efficiency to improve. This resource guide includes helpful information for overcoming common challenges associated with running a cannabis testing laboratory-from inception to staffing. It provides guidance on navigating regulations, testing standards, accreditation, and more. Also included is a guide to choosing chromatography methods, and an expert Q&A on challenges facing the cannabis testing industry. Setting Up and Running a Cannabis Testing Lab: Key Points to Consider Defining operational goals, sourcing lab equipment and testing supplies, and putting the proper people and processes in place by Damon Anderson Despite recent headwinds, with more and more states im- plementing legalized medicinal or recreational cannabis, the industry as a whole continues to grow. Consolidation of production operations may come as a result of multi-state operators and investors looking to capitalize on buying opportunities in market-leading areas. At the same time, small cannabis producers may benefit from state-regu- lated open licensing, brand authenticity, and opportunities to co-op and share resources. As the industry evolves, the demand for high-quality canna- bis testing labs will ultimately continue to increase. Thhen starting and running a cannabis testing lab, there are many important considerations. Setting up a testing lab The first step in setting up a testing lab is defining the goals of the operation-what the lab will test and where will the lab be located and licensed. The types of testing to be done will dictate the instrumentation and the support equip- ment required. The location and the legal requirements At the inception, be sure to: for testing in that market play central roles in determining the performance needed from the equipment and the lab as a whole. Sourcing lab equipment and testing supplies Once research is done and budgets are created, locating sources for the required testing instrumentation and support services is a crucial next step. The process of identifying quality equipment vendors can benefit greatly from knowl- edge and experience gained in the field. A few important details when qualifying equipment ven- dors include: long way toward formation of a repeat sales relationship. It is a good idea to ask vendors to explain the advantages and limitations of various instruments. Have the instruments been tested, vetted, and validated for cannabis and hemp us- age? Quality vendors may conduct special research on usage and publish data, which is strong evidence of performance for your intended applications. Consumables and supplies are areas that can often be over- looked when setting up a lab and securing lab equipment. Thhether the vendor has knowledge of consumables and costs is another measure of a quality provider. Specialized vendors are often needed for solvents, gases, supplies, and other consumables required to operate the equipment, adding another logistics and cost consideration. Consumables such as analytical standards must be tested between vendors and within vendor production batches to identify the best qual- ity. This quality vetting program can amount to additional costs as well. Running a successful testing lab Thhen all the pieces are in place, a successful testing op- eration is ready to run. However, staffing is an additional consideration. Thhile some routine tasks in the lab can be performed by non-technical personnel, there is a strict need for lab professionals with knowledge and experience to lead operations. Technical analysts make critical purchasing decisions, oversee instrument and testing performance, interpret data, identify issues, fix workflow disruptions, and fulfill many other responsibilities. A final consideration is process optimization. Instrument performance, instrument uptime, routine maintenance and validation, and support are all important metrics for a testing operation. "The location and the legal requirements for testing in that market play central roles in determining the performance needed from the equipment and the lab as a whole." Running a successful testing lab through "operational excel- lence" can promote the growth of the scope and scale of testing operations, improve the ability to adapt to changing regulations, and aid in the successful navigation of market fluctuations. Should your testing lab purchase used or refurbished equipment versus new? Here are a few key considerations: Capability-Are you able to locate the equipment needed for your testing methods? Researching both instruments and reputable vendors will help you determine whether used or refurbished equipment can fit your current requirements. Labs looking to add future testing methods, or safeguard against changing regulations, may take a closer look at the latest technology of new products. Reliability-Quality testing demands robust validation methods, which in turn requires instruments with high-quality components. What is the origin of these components? Are they available? Are they susceptible to supply chain disruptions? These are important questions, particularly in the current climate. Support-Who has the best customer service and, when things go wrong, where is the help? What are the chances I'm going to need support and how can I minimize instrument downtime? These are good questions to ask yourself when considering new, used, or refurbished instrument vendors. Budget-New instruments can be expensive. Used or refurbished equipment can be obtained at a lower price, but be sure to consider all the factors above, not just the price tag. After all, time is money. Navigating Regulations in the Cannabis Industry: Hitting a Moving Target Knowledge of local laws and adhering to compliance procedures help ensure best practices by Damon Anderson The cannabis industry offers a wealth of opportunities for those who understand the challenges. The landscape is varied and constantly changing, with some states having established legal frameworks and other states still evolving. The cultivation, processing, testing, and dispensary sides of the industry each come with state and local regulations that vary by location and municipality. Proper licensing and compliance of testing laboratories re- quire substantial monetary investments and careful planning in brokering the best chances at success. A sound manage- ment plan for any cannabis business should involve research to understand the regulations, proper finances to navigate the costs, and steadfast compliance to mitigate the challenges of maintaining a legal operation. Federal regulation of cannabis Although cannabis remains illegal at the federal level, a total of 39 states, the District of Columbia, Guam, Puerto Rico, and the US Virgin Islands have approved comprehensive medical marijuana programs. Of these, 23 states and terri- tories have approved adult-use cannabis and an additional 18 states allow use of "low THC, high CBD (cannabidiol)" cannabis for medical reasons. The 2018 Farm Bill legalized the cultivation and production of hemp in the US. Among the regulations comes a legal requirement of less than 0.3 percent THC in hemp over the entire production chain, from cultivation and processing to sales and transportation. The USDA has accepted proposed regulated plans from 32 states and 21 tribal communities- numbers that will undoubtedly grow as the USDA's program continues to expand. Although legal parameters have been set in place at the state and-in the case of hemp-at the federal level, regulatory measures around licensing and testing are still somewhat flu- id. Firm knowledge of current regulations and awareness of changing policies are absolute necessities to ensure a testing lab achieves and maintains compliance. Click here to visit the USDA website with a summary of the submission and approval status of State and Tribal hemp production plans. State regulations Each state has distinct regulatory requirements, which include processes for licensure, operations, and regulatory enforcement. State laws are put into motion in the wake of federal policy changes, ballot initiatives, and state policy updates. As a result, each state has a roll-out plan and regu- latory processes that are unique, with the possibility of ad- justments due to changes in policy. The availability and type of licenses is also specific for a given state or territory. If a license is approved, it often comes with conditions regarding where the cannabis testing business can physically operate and details regarding adherence to local regulations. "The creation of nationwide cannabis testing standards has been limited by the lack of federal oversight and the void in understanding which levels are safe for consumption, whether those be cannabinoids, pesticides, residual solvents, or other contaminants." State regulatory bodies oversee the implementation of licenses and administration of laws governing access. As an example, Massachusetts enlists the Cannabis Control Commission to oversee the state legal medical and adult use cannabis program. The Cannabis Advisory Board makes recommendations to the control commission regarding reg- ulation and taxation matters. The board consists of various representatives from state services, manufacturing, dispensa- ry sales, laboratory testing, and others with vested interest in cannabis regulatory and commercial matters. Subcommittees are enacted to advise and develop recom- mendations on cultivation, processing, manufacturing, trans- portation, distribution, seed-to-sale tracking, and market stability, among other areas. Together, these entities have the power to enforce the laws and suggest amendments based on the success of operations and regulations, and reflecting changes to public will and market demands. Local regulations During license approval, a cannabis business must also execute an agreement with the local municipality in which it chooses to conduct operations. Upon permission of such business, the municipality will govern the conditions set forth by the local operating agreement. These include: observance of municipal ordinances, enforcements and fines, local taxation, community impact fees, operating fees, and other details. Such cannabis establishments are subject to local zoning and code regulations as well. The processes for applying for licensure, renewal, and the costs associated with operating a licensed business can be extensive. Research to understand the governing bodies, the details of state and local regulation, and knowledge of the fees is essential in any management plan. Securing excess capital will not only cover license and operating fees, but will support a financial contingency plan to deal with compliance and enforcement issues. The ability to handle changes in regulations and market fluctuations is good gen- eral business management. Once licensed, third-party cannabis testing labs must oper- ate under state testing guidelines. Each state is different with respect to testing criteria and enforcement practices. Testing standards The creation of nationwide cannabis testing standards has been limited by the lack of federal oversight and the void in understanding which levels are safe for consumption, whether those be cannabinoids, pesticides, residual solvents, or other contaminants. Until this point, state regulators have deferred to resources such as United States Pharmacopeia and the American Herbal Pharmacopoeia documents in deciding on testing methods, specifications, and standards. Food testing standards set by the USDA for pesticides and heavy metals limits have been adapted by some state canna- bis testing regulators. More recently, organizations such as the Association of Official Analytical Chemists (AOAC) have taken a prominent role in establishing testing standards through the Official Methods of Analysis program. AOAC's Cannabis Analyti- cal Science Program is a forum where cannabis and hemp analysis is discussed among participating labs, and standards and methods are established. The program aims to develop standard method performance requirements for cannabis and hemp based on results from working group members. Expert review panels then evaluate and deliver consensus-based First Action and Final Action Official Methods. The goal is creation of universal testing guidelines for use at the state, and ultimately, the federal levels. Lab accreditation A major component of testing lab regulation is assessment of performance. Thhile many states perform their own lab assessments, a growing number of states rely on ISO/IEC 17025 accreditation from an ILAC-recognized accredita- tion body. Use of these third-party assessments helps instill a high level of performance and diligence in testing lab evaluation. Proficiency testing Many labs perform proficiency testing using well-established protocols for testing. Participation of labs around the world through Inter-Laboratory Comparison gives the laborato- ries a way to demonstrate their competence and gives their customers confidence in the accuracy of results generated by the laboratories. Operating a testing laboratory in an industry devoid of universal standards can be challenging, as licensing and reg- ulatory requirements vary from state to state and can change abruptly with updates in state policies. Federal oversight will foster the creation of universal testing laboratory standards. In the meantime, best business practices include knowledge of state and local laws and strict adherence to performance and compliance procedures. ISO/IEC 17025 is an international standard that specifies the general requirements for the competence of testing and calibration laboratories. It encompasses management and technical requirements, accreditation, and traceability of measurements. 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Our high-shear homogenizers can homogenize down to a sub-micron level, ideal for creating stable, uniform emulsions essential for shelf-stable cannabis- infused products. CLICK HERE TO LEARN MORE D-Series Digital Benchtop Homogenizer Premium MaX-Homogenizing Package Chromatography in Cannabis Testing Key considerations to choosing a method that's best for a lab's specific needs by Michelle Sprawls Many states in the cannabis industry will have certain regulations put in place requiring growers and processors to test/screen for pesticides, mycotoxins, and residual solvent, as well as validate the potency and terpene levels for each batch. Many multidisciplinary labs are looking for ways to diversify their clientele or find new avenues of research for their lab, but don't know how to apply existing chromatog- raphy instruments to cannabis testing or how to select new ones to add to their arsenal. This article covers key consid- erations for choosing a method and chromatography instru- ments for your specific needs. Cannabinoid profile analysis Cannabinoids are a specific chemical class found in cannabis that are produced in the glandular trichomes of the plant and can be analyzed via high performance liquid chroma- tography (HPLC). HPLC-based systems with ultraviolet (UV) detectors have been the gold standard in cannabinoid analysis. The amount of each cannabinoid is determined by shining UV light on the separated compounds. Each canna- binoid absorbs the UV light to a different extent depending on its concentration. By measuring the amount of UV light that is absorbed by each cannabinoid, you can determine the quantity. Potency levels will vary from cultivar to cultivar, making the quantification of tetrahydrocannabinol (THC), cannabidiol, cannabinol, and cannabigerol and other phyto- cannabinoids, as well as their native acid forms, a necessity for dosage. The analysis of both cannabis flower and extracts is commonly performed using a certified cannabinoid refer- ence standard and 10-minute analysis of the 11 cannabinoids on a C18 column. The main advantage of HPLC versus gas chromatography (GC) is the ability to quantify both acidic and neutral forms of cannabinoids without derivatization because high temperatures are not required for the analysis. HPLC provides a more comprehensive chemical report of cannabis samples compared to GC.1 Liquid chromatography mass spectrometry (LC/MS) is used for cannabis and hemp potency testing in scenarios when identification is critical. An LC/MS system contains an HPLC as described above but instead of a non-selective UV detector, the detector is a mass spectrometer. Since the mole- cules are measurable by their mass, LC/MS provides highly selective, quantitative results. LC/MS is the most sensitive and selective testing methodology available on a commer- cial scale. It delivers accurate results on samples in complex matrices, enabling cannabis and hemp testing labs to identify unique molecular features. There are over 100 cannabinoids in cannabis. Some of the most well- known cannabinoids include: Terpene and residual solvent analysis Terpene and terpenoid compounds are naturally occurring aromatic compounds that give cannabis its unique flavor and aroma. Apart from the aromatic properties and their advantageous health benefits, they also have a synergistic relationship with cannabinoids, which further enhance the therapeutic effect of THC. Monoterpenes, diterpenes, and sesquiterpenes can be characterized by investigating the number of repeating units of isoprene, a five-carbon molecule that is the structural hallmark of all terpenoid compounds. The concentrations of individual terpenes vary by strain, harvest time, and drying/curing spaces. A robust analytical method is necessary to chemically profile terpenes in cannabis and cannabinoid products. The most common approach to terpene analysis is headspace GC with flame ionization detection, mass spectrometry (MS), or both. Uti- lizing headspace via pressure-balanced injection is a rapid, straightforward, accurate, and precise solution. This solution also allows the components of interest (for example, residual solvents and terpenes) to be introduced into the analyti- cal system. Factors to consider when selecting chromatography columns. Gas Chromatography Liquid Chromatography Phase (e.g. DB-5, DB-1, DB-1701) Phase (e.g. C18, C8, C4) Length and diameter Length and diameter Stationary phase compatibility Particle and pore size Operating conditions Mobile phase compatibility Detector compatibility Detector compatibility GC-MS is an efficient and robust technique to investigate cannabis products for terpenes, providing chromatographic resolution, identification, and quantitation. GC columns can enhance identification by overcoming the challenges posed by isomers and differences in the aromatic character of terpenes. The use of high-quality standards, reagents, and chromatography consumables is a prerequisite for accurate and reliable testing and detection of terpenes in cannabis crops and cannabis-derived products. Terpenes are compounds that give cannabis strains their distinctive aroma. Common terpenes include myrcene (herbal, earthy), limonene (citrusy), pinene (pine), beta-caryophyllene (spicy, peppery), and linalool (floral, lavender) to name a few. Residual solvent analysis is performed through headspace gas chromatography/mass spectrometry analysis. The major benefit of this approach is that headspace is a fast, simple, accurate, and precise technique that allows the components of interest (e.g., residual solvents) to be introduced into the analytical system. A sample is placed in a closed sampling vessel and heated using a known temperature profile. The chromatographic peaks are well separated with a runtime of about seven and a half minutes and a sample-to-sample cycle time of less than 11 minutes. Using MS allows for the iden- tification of components without concern for false positives, while still maintaining extremely fast run times. Selecting the proper GC column for residual solvents or terpenes should be based on four significant factors: stationary phase, column internal diameter, film thickness, and column length. The correct choice of CRMs, analytical reference standards, high-purity solvents, and columns form the basis of method development. Pesticide and mycotoxin analysis Potentially harmful pesticides and mycotoxins may be present in cannabis crops and extracts despite being legal for sale. Pesticides are classified into seven major groups based on the field of use: insecticides, herbicides, fungicides, ro- denticides, acaricides, molluscicides, and nematicides. Most pesticides have a negative health impact on humans and the environment, resulting in their restricted use or a total ban. Mycotoxins are highly toxic secondary metabolites of certain fungi and molds that easily contaminate food crops. Accurate methods for identification and quantitation of pesticides and mycotoxins in cannabis are essential for con- sumer safety; however, there are currently no harmonized guidelines for pesticide and mycotoxin residue tolerances. Consequently, each state has its own list of such contami- nants with legal residual tolerance limits that may be quite different in each region. The selectivity and sensitivity re- quired for determining residual pesticides and mycotoxins in these complex matrices can only be achieved through a dual platform approach using both LC/MS/MS and GC/MS/ MS. This dual-instrument approach is recommended to get the throughput needed to be successful compared to a LC/ MS/MS-only approach. LC-MS/MS is the method of choice for pesticide and mycotoxin analysis with superior selectivity and sensitivity, especially for pesticide and mycotoxin residues with differ- ent polarities and molecular weights in complex matrices. GC-MS/MS is a selective and sensitive method for volatile and hydrophobic pesticides such as organophosphates and organochlorines. The use of analyte protectants can re- duce adverse matrix-related effects and derivatization can improve detection and method sensitivity. A combination of both GC-MS/MS and LC-MS/MS is used for multi-resi- due pesticide and mycotoxin analysis. Tandem quadrupole MS offers high sensitivity and selectivity for simultaneous analysis of hundreds of pesticides at low ng/g (ppb) levels in a single analysis. Cannabis growers and dispensaries benefit tremendously from the testing performed at independent laboratories. This testing determines potencies, reduces the risk of contamination, and improves product quality. Routine cannabis testing services include cannabinoid potency testing, terpene profiling, pesticide screening, residual solvents, heavy metals, and moisture content. Potency TESTING Most labs quantitate levels of at least three major cannabinoids: THC, CBD and CBN and their dinerent forms (carboxylated vs decarboxylated). You can use gas chromatography (GC), GC-FID and GC-MS, as well as HPLC to determine these levels. Potency testing accompanied with proper product labeling is needed to ensure that customers know exactly how much of the cannabinoids they are consuming. CBD cbn thc Terpene Profiling Terpenes are all flavor and fragrance components common to human diets. Terpene profiling is crucial for dinerentiating between strains of cannabis, as terpenes have a major influence on the medical and psychological enects of the plant. Mass spectrometers or GC-FID are used to test for over 35 commonly found terpenes. A-PINENE myrcene limonele lINALOOL Pesticide Screening An enormous number of pesticides are available in the commercial marketplace, and no lab can test for all of them. While there are currently no guidelines for residual pesticide screening in cannabis, most labs test for the most common pesticides employed during cannabis cultivation: organophosphates, carbamates, pyrethroids, and avermectins. GC-MS is the preferred instrumentation platform for such testing. WARNING Cannabis growers and dispensaries benefit tremendously from the testing performed at independent laboratories. This testing determines potencies, reduces the risk of contamination, and improves product quality. Routine cannabis testing services include cannabinoid potency testing, terpene profiling, pesticide screening, residual solvents, heavy metals, and moisture content. Residual Solvents Hydrocarbon gases like butane and propane and organic solvents like ethanol, isopropanol, and hexane are used to extract the essential oils out of cannabis to create highly concentrated, purified extracts. Residual solvents are the solvents that remain in cannabis oils, shatters, waxes, and budders after these extractions, or after post-extraction processes such as winterization. Residual solvent testing is done on a GC-FID with headspace sampler; GC-MS can also be used. Numerous cannabis samples can be analyzed by various GC instruments so long as the compounds are reasonably vol- atile yet are thermally stable. These factors impact column efficiency, resolution, and sample capacity. There are no easy shortcuts to optimizing a good method. Instrument vendors can provide good tools and methods as a starting point, but laboratories should be prepared to customize these further to perfectly suit the workflow and capabilities of their facility. References: 1. Thang, M., Thang, Y. H., Avula, B., Radwan, M. M., Thanas, A. S., van Antwerp, J., ... & Khan, I. A. (2016). Decarboxyl- ation study of acidic cannabinoids: a novel approach using ultra-high-performance supercritical fluid chromatogra- phy/photodiode array-mass spectrometry. Cannabis and cannabinoid research, 1(1), 262-271. Developing a Standard for Cannabis Sample Prep in Quality Control Testing QuEChERS is the gold standard for cannabis sample prep by Brandoch Cook Cannabis has become a legitimized global retail market- place. Even though the federal Drug Enforcement Agency still recognizes cannabis as a Schedule I substance (illegal and with high potential for abuse), the National Institutes of Health devoted nearly $100 million to cannabis medical research in 2022. The state of the market is a murky gumbo consisting of a handful of legitimate FDA-approved pharmaceuticals, as well as hundreds of vaporizable, edible, and topical products. These products may contain the nonintoxicating compound canna- bidiol (CBD), or the psychoactive compound tetrahydrocan- nabinol (THC). Thith a lack of FDA regulation, consensus, or Sample preparation is a crucial consideration, but has struggled with credibility within the wider testing industry for several reasons: consistency from state to state on recommended dosages, and discrepancies between countries on allowable impurity levels, the amounts people are ingesting or applying can vary widely. There is consequently an evolving quality control industry to support the cannabis market, and the Bureau of Cannabis Control in California implemented comprehensive regulations requiring cannabis derivatives to be QC-tested before they can be qualified for sale in dispensaries. Therefore, California has led a national trend in the establishment of fully certified cannabis QC testing labs. Realistically, however, QC testing is a major bottleneck in the production and distribution stream, with many more accredited laboratories needed, and a demand for producers themselves to develop in-house QC capabilities through the purchase of instrumentation, and recruitment of qualified experts. The basics of cannabis sample prep for GC-MS or LC-MS The QC bottleneck can be exacerbated by inadequately re- producible sample preparation. The current gold standard for sample prep comes from QC analysis of fruits and vegetables to meet FDA standards, and is called QuEChERS (Quick, Easy, Cheap, Rugged, and Safe). Recently, a working group within the Association of Official Analytical Chemists (AOAC) recommended the adoption of QuEChERS as a cannabis industry standard. QuEChERS for cannabis is analogous to the procedure of salt- ing out and dispersive solid phase extraction used for produce, but is complicated by two interrelated factors: sample size and heterogeneity. The recommended sample size in California is one gram per batch of plant, and a single batch may be up to 50 pounds. A batch may therefore contain material from different microenvironments within adjacent plots of soil, and conse- quently incorporate widely different cannabinoid, pesticide, and heavy metal levels and identities. The recommended solution is to randomize samples by taking small amounts from different parts of a batch, and combining them to make up a total of one gram. This can be accom- plished by quartering, or dividing a mixture diagonally into fourths and remixing it. After this step, QuEChERS becomes a straightforward preparation for quantitative, analytical gas chromatography-mass spectrometry (GC-MS) or liquid chro- matography-mass spectrometry (LC-MS). Even within the disparate and ever-changing state-dependent regulatory environment, instrument supply companies are co- ordinating with cannabis producers and testing labs to develop standards and streamline sample prep workflow. Facing Key Cha lenges in the Cannabis Testing Industry A Q&A with Susan Audino, PhD, analytical chemist/ chemometrician and independent consultant by Lauren Everett Q: What is the main hurdle for cannabis testing labs to become profitable? A: Most likely it will be customer retention. Laboratories are largely operating during a time of ambiguity with insufficient direction that results in customers directing laboratory science. For example, a laboratory that has de- veloped an exceptionally precise and accurate test method with well-defined measurement uncertainties may provide test results that are not favorable to a customer. Thhen faced with the loss of that customer, a laboratory may make a business decision to amend the test method to reduce performance, and thereby provide larger uncertainty (pre- sumably to capture the regulatory specifications) in order to meet customer requirements. Q: What are some of the most expensive aspects of running a cannabis testing lab? A: This will be capital expenses for a start-up laboratory. Instruments are expensive. In my opinion, staffing would be next in line. Laboratories should strive for highly expe- rienced laboratory personnel who have "been around the block" a few times and who have developed an arsenal of problem-solving skills to address the inevitable wrinkles that present at a laboratory. Related to this is staff reten- tion-staff need to feel respected for their work as scientists, need to be appreciated for the scientific integrity they bring to the laboratory, and be provided external opportunities for professional development. All of these elements position the laboratory for technical success. Finally, another major expense is consumable materials, such as reference materials that should be integral to every assay. Q: What are the biggest challenges associated with running a cannabis lab today? A: Regulatory specifications that may not always be based on sound scientific processes or abilities. This positions the laboratory to develop methods presumably to ensure consumer health and safety, but can drive laboratory custom- ers (product manufacturers) out of business. Essentially, the laboratory is forced to juggle regulatory requirements (to be in business) with customer needs (to stay in business) and scientific integrity (to ensure confidence in results), which inevitably leads to compromise. Susan Audino, PhD, analytical chemist/ chemometrician and independent consultant Q: How have you seen instrumentation improve to better suit the needs of cannabis testing labs? A: Instrumentation and applications for instruments have continually improved just as they have in other industries. Ultimately, the benefits and utilities of instruments can only be realized by well-experienced scientists, many of whom have only cursory experience/knowledge and do not fully embrace the capacity of their equipment. As instruments and their drivers advance, they often appear to be "plug and play" and give the appearance of "anyone can run this," which of course, is not true. Although just about anyone can be taught the buttons to push, understanding what's going on inside that black box is critically important and should never be underestimated. Q: How has the regulatory landscape evolved, and how do you envision it will change in the next few years? A: I continue to admire and respect the incredible work of all regulatory bodies. They were put in a position where essen- tially overnight they were required to change from prosecu- tion to regulation for consumer safety. Thhat an incredible paradigm shift for them! Nevertheless, this resulted in regula- tions driving science, and because science is always time-con- suming and is late to the game, the landscape is evolving. It has been exciting to see non-scientist regulators more willing to embrace and learn science. As an entity, they continue to engage with scientific communities such as AOAC Interna- tional. The CANNRA (Cannabis Regulators Association) cooperative engages more than 30 state regulatory bodies. As the regulatory infrastructure becomes more centralized and their collaboration with science continues, the landscape will also evolve. Only through collaborative efforts will the natural order shift and laboratories will not have to compromise sci- ence to maintain their customer base to remain in business. Q: Where is the cannabis industry currently in terms of standardizing testing/methodology? A: First, ISO/IEC 17025 is essentially a staple for every test- ing laboratory. As the international gold standard for techni- cal competence, this should be a requirement. The standard does not prescribe practices for the cannabis industry; in its entirety, it requires the laboratory to develop a system based on individual risk. This flexibility frequently leads laboratories to do the bare minimum to ensure compliance. Thus, there are several organizations currently developing requirements to supplement ISO/IEC 17025 that will pro- vide cannabis laboratories more specific direction and higher expectations. Supplement requirements are not new and exist in other industries, such as food. On the front for actual test methods, several organizations are developing standardized methods. Several test methods have gone through single and multiple laboratory valida- tions and have been published. The have to remember that sound scientific processes do not occur in a vacuum and are not quickly developed; they take time. Also, it is important to remember that vetting a test method as a standard test method should not be based on a popularity contest. It must be vetted by experts with known and demonstrated expertise in the subject matter to ensure the (candidate) methods are sound and fit for purpose. Originally published on Labmanager.com PRO Scientific is a global leader in the production of mechanical homogenizing equipment and systems, designed to handle everything from micro volumes to larger multi-liter samples. Our product range includes high-quality handheld devices, benchtop equipment, and advanced automated systems, all proudly made in the USA. Our innovative DPS-20 and Multi-Prep Homogenizing Systems offer cutting-edge high-throughput homogenization solutions. Precision-crafted PRO Generator Probes deliver quick, effective, and consistent results, ensuring reliability in every application. 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