Tag Archives: Testing

February 23, 2016

Ask the Expert: Straight Talk on Safety, Defense and Security, Part II

By Aaron G. Biros, Bruce E. Lesniak, Lezli Engelking

In this week’s Straight Talk on Safety, Defense and Security, we answer a reader’s question about traceability in quality processes and offer some practical advice for building a safety and security strategy. Travis Lodolinsky from Gleason Technology submitted this week’s question. For a response, we sit down with Lezli Engelking, founder of the Foundation of Cannabis Unified Standards (FOCUS), to help answer your questions. If you have questions about safety, defense and security in cannabis, please ask them in the comments section below and we will address them in the next edition of Straight Talk on Safety, Defense and Security.

T. Lodolinsky: How are safety processes being tracked in the industry to ensure regulations and quality assurance are being uniformly enforced throughout?

Lezli Engelking: In related industries, such as herbal products or pharmaceuticals, the FDA has created guidelines, or current good manufacturing processes (CGMP) that control for the quality, consistency and safety of the products being produced. Businesses must be certified by independent third parties to demonstrate they are following CGMP to protect public health and consumer safety. CGMP is a proactive approach to quality assurance. A basic tenant of CGMP is that quality cannot be tested into a product after it is made; quality must be built into the product during all stages of the manufacturing process. One common misconception is that CGMP only covers the process of manufacturing itself. CGMP actually covers all aspects of the production process including materials, premises, equipment, storage, staff training and hygiene, how complaints are handled and record keeping.

Because cannabis is federally illegal in the US, the FDA has not developed cannabis-specific CGMP guidelines, so lawmakers do not have the benefit of having those guidelines available to base regulations on. So to answer your question, state cannabis regulations do not track processes and procedures used by cannabis businesses to control for safety or quality because they do not have the federal guidelines. Instead, most state cannabis regulations currently take a reactive approach to safety, mandating only for testing of the final product. While testing is an extremely important and valuable part of any quality management program, just analytics is not enough.

This is precisely why FOCUS was created and how they assist business owners and regulators, while fulfilling the mission of protecting public health, consumer safety and safeguarding the environment. The FOCUS standards are a cannabis-specific system of guidelines (cannabis-specific current good manufacturing practices) to ensure products are consistently produced according to quality standards. FOCUS provides detailed guidance and independent, third party auditing services for all key aspects of the cannabis industry including cultivation, extraction, infusion, retail, laboratory, security, packaging, labeling and sustainability.

CannabisIndustryJournal: What advice can you offer to cannabis businesses for product safety, defense and security prior to standardization?

Bruce E. Lesniak: Businesses that make products infused with cannabis (I call these businesses “plus one” companies because they produce products that include one more ingredient than traditional food products), require a carefully written master plan that specifically addresses the unique qualities, sensitivities and critical areas of the business. When building a comprehensive plan I address three questions:

Why (identify the why, this is your preventative, overarching strategy)?
How (addresses the “why question” with products, services and training)?
What (what is your reactive strategy that addresses actions and activities to be performed in the event of a breech)?

First and foremost, consumer-facing businesses must safeguard their products to the public. One product recall or illness related incident could spell disaster. Build your plan correctly the first time. Contact an industry expert to review your facility and help build and implement your plan. This will save you money by quickly exposing vulnerabilities and providing corrective measures specific to your business needs and requirements. Even though product safety and defense are closely related to security and should share a complementary strategy, product safety and defense are unique (due to standards and regulations), and should be treated as such.

Banks not accepting industry money complicates normal business operations and security planning, causing retail operations to handle and store large sums of cash. I asked industry expert and security professional, Tony Gallo of Sapphire Protection LLC, what is the single most important piece of security equipment you are currently providing for the retail and dispensary owner? “Design an air tight policy of handling money,” says Gallo. “Remove money often from cash registers and place it into the best safe for your application!”

Spend time familiarizing yourself with all things product safety and defense (there are volumes written on food safety and food defense, thus the “plus one” reference). This a great starting point and protecting the consumer protects your business. When it comes to designing your security application, consult an expert! Take into account that the cannabis industry is unique due to its “plus one” ingredient. Therefore you need to build your security systems, applications and policies to systematically protect your employees, facility, suppliers, transportation, manufacturing, distribution, warehousing, supply chain and brand.

February 17, 2016

Amanda Rigdon to Offer Guidance on Method Validation at Cannabis Labs Conference

By Aaron G. Biros

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With multiple states now requiring third-party certification as part of licensing cannabis laboratories, there is a large role for laboratory accreditation in the cannabis industry. Using method validation can prove that your data is reproducible and that you have robust methods for sample preparation and calibration. All of these tools are instrumental in getting a laboratory accredited.

Amanda Rigdon, associate marketing manager for GC columns at Restek, Inc. — Amanda Rigdon, associate marketing manager for GC columns at Restek

Amanda Rigdon, associate marketing manager for gas chromatography columns at Restek, Inc., will deliver a presentation, Opportunities and Challenges for Method Validation in the Evolving Cannabis Industry, at the first annual Cannabis Labs Conference taking place this March 9^th in Atlanta, Georgia. The Cannabis Labs Conference will be co-located with the third annual Food Labs Conference and the Pittsburgh Conference on Analytical Chemistry and Applied Spectroscopy (Pittcon) at the Georgia World Congress Center.

In her presentation, Rigdon will discuss established validation guidelines from a variety of regulatory bodies. “Method validation is absolutely critical to the cannabis industry,” she says. “Accurate test results not only help to protect consumers, but because of the high dollar value of cannabis products, accurate results can also protect producers from false positives, and laboratories in backing up their results.” She will also be sharing actual validation data from a number of cannabis analytical methods.

Scott Radcliffe, technical support scientist at Romer Labs, Inc., will share his validation methods of immunoassays for the detection of pathogens and mycotoxins in cannabis. He will include a discussion of specific rapid pathogen detection methods for Salmonella and E. coli O157 species. This will cover their small-scale validation studies with partner labs in Michigan and Washington for immunoassays.

stevegoldner — Stephen Goldner, Esq, founder of Pinnacle Laboratory and Regulatory Affairs Associates

Stephen Goldner, Esq, founder of Pinnacle Laboratories, will discuss how cannabis labs can apply FDA lab practices with recommendations for short and long term management implementation. Goldner’s presentation will include a discussion of preparation for FDA involvement in sate regulatory systems.

Beyond validation methods in laboratories, the Cannabis Labs Conference will feature several presentations on ISO/IEC 17025:2005 compliance, the need for standardization, seed-to-sale traceability, FDA best lab practices and cannabis quality. Nic Easley, chief executive officer of Comprehensive Cannabis Consulting (3C), will deliver the keynote presentation on the role of quality assurance in the cannabis industry.

February 11, 2016

Cannabis Coaching & Compliance

Avoiding Recalls: Preparing for the What-Ifs

By Maureen McNamara

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Recalls are a necessary part of our lives, and they occur quite often. There are hundreds of food recalls performed each year. Now we are experiencing recalls in the cannabis industry. It is important to keep in mind that the primary objective of performing a recall is to protect consumer safety.

Welcome to a whole new game!

The Scoop:

A recall occurs to remove defective or potentially harmful products from the marketplace.

Recalls can be expensive and stigmatizing. Companies involved are usually highly motivated to remedy the issue and recover as quickly as possible. It is in the producer’s best interest to do everything in their power to maintain and regain patient & customer confidence and brand trust as soon as possible.

In the United States, food recalls are typically generated by the U.S. Food and Drug Administration (FDA), or by the U.S. Department of Agriculture (USDA) through the Food Safety and Inspection Service (FSIS). Food manufacturers regularly perform mock recalls and, when needed, perform voluntary recalls of possibly contaminated product. Recently, listeria has become a major concern for contamination in the food industry and as a result, many companies are preparing themselves for prevention strategies.

As cannabis is still federally illegal, the FDA does not perform cannabis recalls. As a result, we are seeing local health departments and the state departments of agriculture getting involved in cannabis recalls. Recent recalls are voluntary and are related to potentially dangerous pesticide residue on flower, concentrates and infused products. Colorado has come into the spotlight recently for businesses performing a number of voluntary recalls, in the interest of protecting consumer safety. This January, a recall included “individual units of marijuana concentrates that are used for vaporizing” testing positive for Imidacloprid, Myclobutanil, Etoxazole and/or Avermectin, which are all pesticides determined by the Colorado Department of Agriculture as not usable on cannabis.

How do we know there is a problem?

A manufacturer discovers a problem
Inspectors reveal a potential issue
A product fails a test carried out by a licensed laboratory
A state health department may be alerted to an issue

Preparing for the “What- Ifs”

What is your crisis management strategy?
How will your team communicate the issue with regulators?
What is the protocol to recover or destroy recalled product?
What is the communication plan with purveyors & consumers?
What new structures will be in place to prevent future issues?

How do we avoid a Recall?

Manufacturers and cultivators endeavor to prevent issues in the first place. Good Manufacturing Practices (GMP), Good Agricultural Practices (GAP) and Hazard Analysis and Critical Control Points (HACCP) plans are used to ensure quality and safety during the production process. Mistakes can occur. It is ultimately the manufacturer’s responsibility to remove any possibly contaminated product from the market quickly and before potential damage is incurred.

As we pioneer the cannabis industry, it is important to be as proactive as possible at every step of the supply chain, from seed to the sale of cannabis: Cultivating, trimming, curing, extracting, infusing, producing, packaging, shipping, receiving, storing and selling are all points where safety measures should be in place.

Prevention Rules!

How is your team doing with the following?

GAP, GMP & HACCP plans to ensure quality product
Testing, TESTING, Testing- to confirm safety of your goods
Requiring strict & tested operating procedures from your suppliers
Internal quality reviews
Training and Accountability

Our desire is that you do not ever need to recover from a crisis, but mistakes happen. They create a learning opportunity for us to make a higher quality product, to strengthen our procedures and to show our consumers that we are committed to excellence.

October 23, 2015

Setting a Benchmark in Cannabis Testing: GOAT Labs

By Aaron G. Biros

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GOAT Labs, Inc. is a veteran-owned, i502-certified cannabis testing company with laboratories in Vancouver, Washington and Portland, Oregon. The laboratory launched in 2010 by Dana Luce, the owner, with a personal mission to provide safe and tested cannabis to patients in need.

Dana Luce’s daughter, Dani Luce, CEO of GOAT Labs, has previous experience working in dialysis and watched cancer patients lose their battle to the illness. Many years later, Dani’s oldest son was diagnosed with stage IV Hodgkin lymphoma. Cannabis proved instrumental in alleviating the side effects of chemotherapy. “With a severely compromised immune system, we had to find a place to test all the raw foods given to him, including cannabis,” says Dani Luce.

Dani Luce’s son was in remission nine months after starting chemotherapy in conjunction with cannabis and has now been in remission for five years. “We want to ensure patients are not ingesting something potentially toxic and that proper testing is done, which includes not only potency, but testing for microbials, pathogens, and pesticides.”

GOAT Labs is a member of the Cannabis Coalition for Standards and Ethics (CCSE) along with the American Oil Chemist Society (AOCS), where they participate in the Expert Committee for Cannabis Oil.

With pesticide use on cannabis recently entering the spotlight, there is a growing need for standards in cannabis testing. “We need better regulatory oversight so that all laboratories are standardized, including proficiency testing done by the state,” argues the Luce’s.

billlucesample — Bill Luce, lab technician at GOAT Labs, preparing samples for testing

Roger Brauninger, biosafety program manager of A2LA (American Association for Lab Accreditation), is working on an accreditation process for cannabis laboratories that would be accepted nationally. “We believe that an accreditation process would increase efficacy of lab results, reduce laboratory shopping, and create consistency with results across different laboratories,” says Brauninger.

GOAT Labs, among a number of other laboratories and organizations, is working toward putting cannabis in the lens of mainstream medicine. Not only are they looking to achieve a safe standard for medicine, they are advancing legalization efforts nationwide by setting the benchmark for getting patients access to safe, lab-tested cannabis.

October 19, 2015

Manufacturing Edibles With Integrity

By Aaron G. Biros

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Without federal guidance on food products containing marijuana (a result of the plant remaining a Schedule I narcotic), state regulators and manufacturers are fighting to keep the market safe for consumers. Manufacturers of marijuana edibles are not only trying to ensure consumer safety, but are also attempting to advance industry and legalization efforts nationwide.

Recent investigations in Colorado revealed that certain marijuana edibles, along with some extracts, tested positive for illegal pesticides. Many cannabis businesses are looking to the industry leaders in edibles manufacturing for advice. Marijuana edibles are a food product, so they must first enlist standard food sanitation procedures and then comply with state regulations for cannabis to ensure safety. Some of the product consumers are patients with weakened immune systems, thus highlighting the need for consistent and accurate dosing in products.

Maureen McNamara, founder of Cannabis Trainers, recently sat on a panel with Bob Eschino, co-founder of incredibles and Krystal Kiathara, CEO of Yummi Karma at the Cannabis World Congress and Business Expo, hosted by the International Cannabis Association in Los Angeles. The panelists discussed the need for integrity in manufacturing edibles.

The regulations are not quite there yet and states are adjusting legislation to help promote safety. “It is our job to educate legislators and make sure that our products are accurate and consistent,” said Bob Eschino, co-founder of incredibles.

Maureen McNamara says there are four criteria for producing edibles with integrity: Compliance, training, research and product testing.

“Starting with the foundation of compliance, utilizing strategies involving HACCP plans and FDA guidance, the first pillar is training,” says McNamara. “Food safety training is essential to ensure your team is aware and making a wholesome product.” She also stressed the importance of shelf-life testing and R&D before the product goes onto shelves.

Because food laboratories often will not test products that contain cannabis, many companies work with food scientists and in-house testing. “Moving forward, we need to ensure that we achieve consistent results from the various testing labs,” said McNamara. “But to make edibles with integrity, laboratory testing is paramount.”

August 19, 2015

Cannabis Labs: The Need For Standardized Analytics

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Laboratory testing is an integral part of the cannabis industry for the same reasons it is important in the food industry. To ensure the consumer is ingesting a safe product, accurate testing should be required for microbials, pathogens, pesticides, heavy metals, and perhaps most importantly dosage. Unfortunately, however, the problem is that testing requirements are not quite there yet in the handful of states that have legalized marijuana for recreational or medical purposes. This creates a degree of uncertainty in the marketplace, which is detrimental to the growth of the industry as a whole.

Cannabis samples are liquified in strong acid in a pressurized microwave prior to evaluation for heavy metal content. Image courtesy of Digipath, Inc.

Lauren Finesilver, Executive Chef at Sweet Grass Kitchen, sits on a counsel for compliance with C4 (Colorado Cannabis Chamber of Commerce). Finesilver believes “We are a food manufacturer first and foremost so we need to ensure we sell a final product that is safe for the public and [one] that consumers know is coming from a responsible manufacturer.” Ahead of marijuana rule changes that are soon to come, Colorado’s Marijuana Enforcement Division (MED) announced five new rulemaking working groups, one of which will address testing, packaging, and labeling.

Some states, including Colorado and Nevada, have made impressive strides in implementing proper testing regulations.

“Nevada has done a really good job from the start in designing a program where they have at least addressed some of the issues with product quality including testing, labeling, and potency requirements,” says Tobias Paquet, Chief Scientific Officer of C3 Labs, LLC (Cannabis Chemistry Consulting).

Paquet, who previously worked at Waters Corporation as a field chemistry specialist, cites potential contamination at almost every step of the cannabis supply chain from seed to sale. “Some of the biggest concerns with contamination during cultivation or extraction are pesticides, heavy metals, and microbial contamination,” he says, adding that he is most concerned about two microbial carcinogens—mycotoxin and aflatoxins.

“We aim to provide reliable and consistent labeling that is accurate and reflects the contents of that product,” says Paquet. “This comes with a validated method on qualified instruments and laboratory accreditation.”

Determining the moisture content in a dried cannabis sample for adjusting potency numbers and checking for appropriate curing. Image courtesy of Digipath, Inc.

Much like the food industry, accurate testing across the board is needed for consumers to feel safe ingesting edibles containing marijuana. Laboratories that operate in states where marijuana is already legal need to utilize good laboratory practices and standards to ensure consistency.

“We have been working to create an accreditation process that is accepted on a national level,” says Roger Brauninger, biosafety program manager at the American Association for Laboratory Accreditation (A2LA). “Without firm state laboratory accreditation regulatory requirements in place, the possibility exists that people may shop laboratories to get the results they want. So if applied across the board, ISO 17025 accreditation would help reduce that, thereby helping to create greater consistency of tests results between laboratories, ultimately helping to reduce marketplace confusion.”

The cannabis industry has the momentum to become a safe and regulated marketplace as state reforms continue, with testing and analytics acting as the wind behind its sails.

Matt Karnes, founder and managing partner of GreenWave Advisors, LLC, suggests that by 2020, assuming full legalization occurs in all 50 states and D.C., the lab testing industry could easily reach $850 million (this figure includes testing, data analytics and consulting services). The firm provides an analysis of each state’s potential market size which is predicated on its U.S. retail marijuana forecast of $35 billion (again, assuming full legalization by 2020). Karnes was recently cited in a Forbes article suggesting that cannabis testing is one of a handful of top new technology investment opportunities.

Karnes’ predictions echo that of many when discussing the cannabis analytics space. “More states are becoming focused on standardized laboratory testing requirements,” he says. “There is really no consistency, which is something that needs to be worked out.”

While a handful of states work toward achieving good laboratory standards, players in the cannabis industry, including laboratories, dispensaries, and cultivators, continue to self-regulate when it comes to safety and quality.

CannabisIndustryJournal.com, our newest publication, will be launched in late September. CannabisIndustryJournal.com will educate the marketplace covering news, technology, business trends, safety, quality, and the regulatory environment, aiding in the advancement of an informed and safe market for the global cannabis industry. Stay tuned for more!