Tag Archives: quality

March 18, 2016

Cannabis Labs Conference Makes History at Pittcon

By Aaron G. Biros

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.

November 11, 2015

Cannabis Coaching & Compliance

Keep It Professional~Food Safety Musts!

By Maureen McNamara

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There are many aspects to the cannabis industry that demand an owner’s attention: Compliance, great products, great people, great location, finances…. So is a focus on food safety a priority?

Yes, yes it is. And not just for infused products.

For starters, in some states like Colorado, it is required. In other states it will be required in the foreseeable future, and generally speaking, it is a vital component for a professional industry that continues to show the community that you are committed to creating safe products.

Have you ever had a foodborne illness? I’m going to assume you just nodded your head or thought yes. Check out this statistic: according to the Center for Disease Control there are about 48 million cases of foodborne illnesses (and 3000 people die) every year in the United States.

A quick reminder about the typical symptoms of foodborne illness: vomiting, diarrhea, headaches and nausea. Experiences we would all like to avoid.

What I know for sure… you do not want your product or your company to ever be associated with making people sick.

Take into account that for medical marijuana patients, they may already have compromised immune systems. This puts them at an even greater risk for foodborne illness. We need to ask questions like “Are my employees doing everything possible to ensure a safe, wholesome product?”

A properly trained staff is a critical necessity in the cannabis industry. Whether it is currently required or not, your commitment to safety for your patients and consumers show that you care and are committed to high standards. Additionally, you may avoid fines, closures and recalls. These all create a drain on your finances… as well as your reputation.

The FDA has identified five key factors that often contribute to outbreaks:

Purchasing Food from Unsafe Sources
Improper Holding Time and Temperature
Inadequate Cooking
Improper Cleaning and Sanitizing
Poor Personal Hygiene

Safe Purchasing:

Be aware of starting with high quality ingredients. Ask your suppliers questions about their inspections and quality controls. If possible conduct a tour of the supplier facilities to verify they meet necessary standards. Are you impressed with their food safety standards and protocols?

Avoiding Time & Temperature Abuse:

Bacteria needs an ideal temperature (between 41°-135°) and a bit of time (4+hours) to grow to harmful levels. Keep your cold food cold and cool your heated foods quickly.

Inadequate Cooking:

If you are infusing oil, I strongly encourage you to work with your local health department for a procedure that will ensure the oil is cooked to a safe temperature (while not interfering with your chemistry) to eliminate potential pathogens or microbials.

Cleaning and Sanitizing:

Microorganisms grow well at room temperature. Cleaning and sanitizing is important to ensure microorganisms are reduced or eliminated. Certainly all of your food contact surfaces must be cleaned and sanitized whenever you change tasks and at least every four hours. This is not just for making infused products, please keep this in mind at the retail level as well. Think of how many hands (both employees and customers) may be touching the product containers. Avoid cross-contamination by cleaning and santizing thoroughly and often.

Personal Hygiene:

In each food safety class I have facilitated in the last 18 years, everyone admits they or their team could improve personal hygiene. Shout out to any bearded folks… did you know that the FDA food code requires facial hair that is 1-inch or longer to be restrained? Got a beard net?

Because most of the foods manufactured in the cannabis industry are “ready to eat” foods, great personal hygiene and frequent, thorough handwashing is essential. The FDA reccommends a 20 second handwashing procudure with hot water (≥100°), a soapy lather, vigoursly rubbing hands for at least 10-15 seconds, rinsing well and using a single-use towel to dry your hands.

I know… it sounds very basic. However, when I observe people washing their hands it is often for less than 8-seconds. Not only is handwashing a great way to stay healthy ourselves, it is a key way to ensure your products are safe and not putting public health in jeopardy.

I’ll throw down a challenge for you! This month: focus with your team on personal hygiene and hand washing. Whether you are growing, infusing or selling this is a vital component for a professional, responsible industry. When it comes down to it, you make things that go right into your customer’s and patient’s bodies. Create those products on a foundation of food safety and you will more easily create a thriving business.

Cannabis Trainers provides ServSafe® food safety training for edible makers and Sell-SMaRT™ the responsible cannabis vendor program for sellers. (www.CannabisTrainers.com)

We would love to hear from you! Comment below and let us know what your team does to ensure you are making and selling safe products.

November 2, 2015

From The Lab

What to Consider When Selecting a Laboratory

By Seth Wong

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There are many factors to consider when selecting a third party analytical laboratory:

Why are you testing?
Does a governing body require it?
Are you testing to meet compliance with industry trends?
Are you testing as supplemental protection to an in house laboratory operation?
Are your results being used to help you market your product?
Are the results being utilized for internal R&D?
What are you looking to get out of testing?

Perhaps it is a combination of all these things. Regardless, whomever you contract with for whatever reasons, it is important to understand what you are getting, know what you are entitled to, understand your results, and understand where you and your company remain vulnerable. You must also be prepared with a plan to handle adverse results. Testing at a third party analytical contract laboratory does not mean they assume all of your product’s or company’s liability, regardless of the lab’s reputation.

Ask your third party laboratory about any accreditations, certifications, and licenses that the lab should be accredited and/or certified for. Each state has different certifications and licensing requirements; make sure the entity you are using is licensed or certified for the services you need. Additionally, there is an accreditation called International Standards Organization (ISO) 17025 that is the pinnacle of third party laboratory accreditation. ISO 17025 is a set of protocols that your third party lab should follow to do everything it can to ensure your data is accurate and produced with reliable standards, control samples, matrix control samples and proficiency tests to verify the accuracy of the lab’s employees and methods, among a number of other criteria included in the standard. A number of different entities offer accreditation to ISO 17025 but it is important that the the accrediting body is also accredited to their ISO standard. Simply buying ISO 17025 compliant materials or standards does not mean that the vendor service or product is accredited to ISO 17025. Cannabis laboratories are just starting to implement and build systems around ISO 17025 but it has been prevalent in the third party lab business in many industries for decades and should be applied to the cannabis industry.

Visit your lab and understand their background and experience. Start by requesting a tour of the laboratory you choose; you want to know how things look behind the scenes. Is the lab orderly and doing its best to protect sample integrity? There may be a lot of things going on in the laboratory and it may look chaotic but it should be relatively clean. This prevents contamination and sample mix-ups. Further your relationship with your laboratory by understanding the laboratory’s experience and getting to know your laboratory staff. Consider the lab staff as part of your extended team, they are there to help you and help bring your product to market. The more they understand your goals, the more they can help.

Understand your lab’s history and background: Have they worked with products and/or analytes similar to yours? Have they worked with your sample matrix or one similar to it before? Their prior knowledge and laboratory experience, as it relates to your product, will help provide accurate data and navigate complex matrices.

Most importantly, a laboratory should be willing to release the data packet that is used to generate test results to the client. Releasing this data does not divulge any proprietary information of the lab. It is the laboratory’s job to provide you with the data upon request. It is important to note, looking at your raw data is not the same as looking at the laboratory method, also known as a work instruction or operating procedure. The lab most likely won’t give you the method as those are typically trade secrets, but there is no reason not to share with you the chromatography that the HPLC, GC, GC/MS, or LC/MS generated. This will demonstrate the lab’s sound analytical data and increase your confidence in the analysis you are receiving. When you pay for the results, you are also paying for your data and if your laboratory is not releasing that information to you at your request, you should be skeptical. This data needs to be able to stand up to audits and legal action.

Finally, confidentiality: your data is your data. Yes, you may have to report results to a governing body, but your laboratory should not be sharing your name and your data with anyone but your authorized list of contacts without your permission. They should not even disclose that you are their client without your prior authorization. Confidentiality is not just applicable to a few key employees at the laboratory, it is pertinent to everyone from the sample pickup driver, if you have one, to the chemists and upper level management.

Understanding your contract laboratory’s certifications, licenses, and accreditations, requesting and receiving raw data packages, and ensuring that you feel comfortable with the laboratory, its staff and their practices are key elements to ensuring a successful relationship with your laboratory.