Tag Archives: QA

California Releases Proposed Emergency Regulations

By Aaron G. Biros
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Last week, the California Bureau of Cannabis Control released their proposed emergency regulations for the industry. The Bureau, the government agency tasked with regulating California’s cannabis industry, announced the proposed emergency regulations ahead of the highly anticipated January 2018 start date.

The Bureau also published helpful fact sheets and overview documents, providing a good snapshot of the major requirements for different types of licenses. Here are some of the key takeaways:

Temporary licenses will allow businesses to operate for 120 days while their annual license application is being processed. Not surprisingly, local jurisdictions have considerable autonomy. Getting a license seems to be contingent on first getting local approval to operate. According to Josh Drayton, communications and outreach director at the California Cannabis Industry Association (CCIA), working with local governments will be crucial to making progress. “Now that the Brown Administration has created the framework for medical and adult use cannabis, the main challenge we face as an industry is getting local municipalities to move forward with regulations,” says Drayton. “California has a dual licensing process which means that cannabis operators must receive a local permit/license/authorization before being able to apply for a state license. A majority of California cities and counties have yet to finalize their regulations which will delay state licensing.”

The initial reactions to these proposed regulations seem positive, given that this is a culmination of efforts over several years. “The California Cannabis Industry Association welcomes the release of the emergency regulations,” says Drayton. “These regulations represent years of hard work and collaboration between the administration, the regulating departments, and the cannabis industry.”

License Distinctions

A-type licenses are for businesses in the adult-use market, while M-type licenses are for the medical market. Laboratory licenses don’t have this distinction, as they can test both medical and adult-use products.

The record keeping and security requirements seem relatively straightforward, requiring normal surveillance measures like 24-hour video, commercial-grade locks and alarm systems. The rules also lay out guidelines for disposing of waste, including securing it on the premises and not selling it.

Distributors

Distributor licenses appear to have a number of compliance documentation requirements, such as arranging for all product testing, quality assurance and packaging and label accuracy. “Cannabis and cannabis products must pass through a distributor prior to being sold to customers at a retail establishment,” reads the overview the Bureau published. There is also a transport-only distributor license option. Those regulations appear to be more comprehensive than others, with a number of regulations pertaining to appropriate transportation and security measures.

Everything has to be packaged before it gets to retail; Retailers are not allowed to package or label cannabis products on premises. Microbusiness licenses will be available, which should be an exciting new development to follow as the market matures.

Labs

The state will require ISO 17025 accreditation for testing labs. A provisional license is required for a lab to operate in the short term, expiring after 12 months. Laboratory personnel are required to go in the field and do the sampling. Documentation requirements, sample sizes, sampling procedures and storage and transportation rules are also laid out.

Testing labs are required to test for cannabinoids, foreign material, heavy metals, microbial impurities, mycotoxins, moisture content and water activity, residual pesticides, residual solvents and processing chemicals and terpenoids (terpenes). Infused and edible products are required to be tested for homogeneity in THC and CBD concentrations as well. Drayton and the CCIA welcome these new testing regulations, hoping it might improve overall public safety. “We believe that these regulations will address public health issues by mandating the testing of all cannabis products,” says Drayton. “The evolution of the cannabis industry will continue, and we will continue to advocate for good policy that creates solutions for the problems that arise. I believe that we will be visiting and revisiting cannabis regulations for many years to come.”

Certificates of analysis (COA) will be required, showing whether a batch passes or fails testing requirements. Harvest batches that fail testing can be processed for remediation. “Testing laboratories are required to develop and implement a quality assurance program that is sufficient to ensure the reliability and validity of the analytical data produced by the laboratory,” reads the statement on QA and QC.

The Bureau, at the end of their regulatory overview document, lays out some possible enforcement actions, disciplinary actions and citations that could come from noncompliance. “These emergency regulations create a framework for both medical and adult use consumers,” says Drayton.  “January 1, 2018 will be the first date that adults 21 years and older will be able to purchase cannabis without a medical card.”

In the coming weeks, we’ll be breaking down and analyzing the other proposed emergency regulations that the state released. Stay tuned for a breakdown of the California Department of Food & Agriculture (CDFA) regulations on cannabis cultivation, as well as The California Department of Public Health (CDPH) cannabis manufacturing regulations.

Quality Assurance In The Field: Instruments For Growers & Processors

By Aaron G. Biros
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As the cannabis marketplace evolves, so does the technology. Cultivators are scaling up their production and commercial-scale operations are focusing more on quality. That greater attention to detail is leading growers, extractors and infused product manufacturers to use analytical chemistry as a quality control tool.

Previously, using analytical instrumentation, like mass spectrometry (MS) or gas chromatography (GC), required experience in the laboratory or with chromatography, a degree in chemistry or a deep understanding of analytical chemistry. This leaves the testing component to those that are competent enough and scientifically capable to use these complex instruments, like laboratory personnel, and that is still the case. As recent as less than two years ago, we began seeing instrument manufacturers making marketing claims that their instrument requires no experience in chromatography.

Instrument manufacturers are now competing in a new market: the instrument designed for quality assurance in the field. These instruments are more compact, lighter and easier to use than their counterparts in the lab. While they are no replacement for an accredited laboratory, manufacturers promise these instruments can give growers an accurate estimate for cannabinoid percentages. Let’s take a look at a few of these instruments designed and marketed for quality assurance in the field, specifically for cannabis producers.

Ellutia GC 200 Series

Shamanics, a cannabis extractor in Amsterdam, uses Ellutia’s 200 series for QA testing

Ellutia is an instrument manufacturer from the UK. They design and produce a range of gas chromatographs, GC accessories, software and consumables, most of which are designed for use in a laboratory. Andrew James, marketing director at Ellutia, says their instrument targeting this segment was originally designed for educational purposes. “The GC is compact in size and lightweight in stature with a full range of detectors,” says James. “This means not only is it portable and easy to access but also easy to use, which is why it was initially intended for the education market.”

Andrew James, marketing director at Ellutia

That original design for use in teaching, James says, is why cannabis producers might find it so user-friendly. “It offers equivalent performance to other GC’s meaning we can easily replace other GC’s performing the same analysis, but our customers can benefit from the lower space requirement, reduced energy bills, service costs and initial capital outlay,” says James. “This ensures the lowest possible cost of ownership, decreasing the cost per analysis and increasing profits on every sample analyzed.”

Shamanics, a cannabis oil extraction company based in Amsterdam, uses Ellutia’s 200 series for quality assurance in their products. According to Bart Roelfsema, co-founder of Shamanics, they have experienced a range of improvements in monitoring quality since they started using the 200 series. “It is very liberating to actually see what you are doing,” says Roelfsema. “If you are a grower, a manufacturer or a seller, it is always reassuring to see what you have and prove or improve on your quality.” Although testing isn’t commonplace in the Netherlands quite yet, the consumer demand is rising for tested products. “We also conduct terpene analysis and cannabinoid acid analysis,” says Roelfsema. “This is a very important aspect of the GC as now it is possible to methylate the sample and test for acids; and the 200 Series is very accurate, which is a huge benefit.” Roelfsema says being able to judge quality product and then relay that information to retail is helping them grow their business and stay ahead of the curve.

908 Devices G908 GC-HPMS

908 Devices, headquartered in Boston, is making a big splash in this new market with their modular G908 GC-HPMS. The company says they are “democratizing chemical analysis by way of mass spectrometry,” with their G908 device. That is a bold claim, but rather appropriate, given that MS used to be reserved strictly for the lab environment. According to Graham Shelver, Ph.D., commercial leader for Applied Markets at 908 Devices Inc., their company is making GC-HPMS readily available to users wanting to test cannabis products, who do not need to be trained analytical chemists.

The G908 device.

Shelver says they have made the hardware modular, letting the user service the device themselves. This, accompanied by simplified software, means you don’t need a Ph.D. to use it. “The “analyzer in a box” design philosophy behind the G908 GC-HPMS and the accompanying JetStream software has been to make using the entire system as straightforward as possible so that routine tasks such as mass axis calibration are reduced to simple single actions and sample injection to results reporting becomes a single button software operation,” says Shelver.

He also says while it is designed for use in the field, laboratories also use it to meet higher-than-usual demand. Both RM3 Labs in Colorado, and ProVerde in Massachusetts, use G908. “RM3’s main goal with the G908 is increased throughput and ProVerde has found it useful in adding an orthogonal and very rapid technique (GC-HPMS) to their suite of cannabis testing instruments,” says Shelver.

Orange Photonics LightLab Cannabis Analyzer

Orange Photonics’ LightLab Cannabis Analyzer

Dylan Wilks, a third generation spectroscopist, launched Orange Photonics with his team to produce analytical tools that are easy to use and can make data accessible where it has been historically absent, such as onsite testing within the cannabis space. According to Stephanie McArdle, president of Orange Photonics, the LightLab Cannabis Analyzer is based on the same principles as HPLC technology, combining liquid chromatography with spectroscopy. Unlike an HPLC however, LightLab is rugged, portable and they claim you do not need to be a chemist to use it.

“LightLab was developed to deliver accurate repeatable results for six primary cannabinoids, D9THC, THC-A, CBD, CBD-A, CBG-A and CBN,” says McArdle. “The sample prep is straightforward: Prepare a homogenous, representative sample, place a measured portion in the provided vial, introduce extraction solvent, input the sample into LightLab and eight minutes later you will have your potency information.” She says their goal is to ensure producers can get lab-grade results.

The hard plastic case is a unique feature of this instrument

McArdle also says the device is designed to test a wide range of samples, allowing growers, processors and infused product manufacturers to use it for quality assurance. “Extracts manufacturers use LightLab to limit loss- they accurately value trim purchases on the spot, they test throughout their extraction process including tests on spent material (raffinate) and of course the final product,” says McArdle. “Edibles manufacturers test the potency of their raw ingredients and check batch dosing. Cultivators use LightLab for strain selection, maturation monitoring, harvesting at peak and tinkering.”

Orange Photonics’ instrument also connects to devices via Wi-Fi and Bluetooth. McArdle says cannabis companies throughout the supply chain use it. “We aren’t trying to replace lab testing, but anyone making a cannabis product is shooting in the dark if they don’t have access to real time data about potency,” says McArdle.

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Colorado Approves Emerald Scientific Proficiency Tests for Regulatory Compliance in Cannabis Testing

By Aaron G. Biros
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Emerald Scientific recently announced their proficiency-testing program, The Emerald Test, has been approved by Colorado as a third party provider for proficiency testing in licensed cannabis laboratories. The Emerald Test, held twice annually, is an inter-laboratory comparison and proficiency test (ILC-PT), allowing data to be collected pertaining to the performance of laboratories on a national scale. Proficiency testing is designed to measure how accurately laboratories perform and is a critical tool for quality assurance.

Colorado requires labs to participate in a proficiency-testing program in order to be certified to conduct required testing on cannabis and cannabis products for safety and quality. According to the press release, Colorado’s Marijuana Enforcement Division, under the Department of Revenue, conducted an evaluation process to determine which applicants could meet the performance standards for regulatory compliance concerning proficiency testing. The contract was awarded to Emerald Scientific following this evaluation process.

emerald test retailAccording to Ken Groggel, director of the Proficiency Testing Program at Emerald Scientific, a number of states have recognized the need for independent proficiency testing as a required piece of regulatory compliance. “The Emerald Test Inter-Laboratory Comparison/PT is state approved in Washington & Colorado for cannabis testing laboratory licensure,” says Groggel. “States with cannabis or hemp production, as well as labs in other countries are now actively participating in the Emerald Test as a tool for quality improvement, efficiency upgrades and product safety.” He says the Colorado Marijuana Enforcement Division has contracted with Emerald Scientific to provide third party PT programs for microbial contaminants, residual solvents and pesticides.

Ken Groggel, director of the Proficiency Testing Program at Emerald Scientific

Beginning in 2014, The Emerald Test has been offered twice a year and, in 2017, over 50 labs participated from 14 states and 2 countries. “Laboratories that have enrolled more than once have seen significant improvement in their results, an indicator of improved performance for industry customers,” says Groggel.

Proficiency testing is important for ensuring quality, safety and product content accuracy. “This should be the priority whether you are a grower, manufacturer, testing laboratory, regulatory entity, medical patient or adult use consumer,” says Groggel. It also helps labs meet regulatory requirements and achieve ISO 17025 accreditation. “Independent proficiency testing helps determine if the lab is able to deliver the services marketed to its customers,” says Groggel. “Regulatory agencies can use this information when licensing, monitoring & enforcing good science for public safety.”

As new states legalize cannabis and develop consumer protection regulations, proficiency testing programs can help labs demonstrate their commitment to responsible and accurate testing. “When PT results show the cannabis testing lab is capable it is up to the government to ensure accountability for performance on behalf of all its citizens,” says Groggel. Labs can enroll starting on September 25th in the Fall 2017 Emerald Test ILC/PT.

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Quality From Canada

Secure Software Monitoring — Two Keys to Success

By Tegan Adams
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We have two key software platforms at our laboratory that help us stay compliant with our standard operating procedures. Saif Al-Dujaili, quality manager at Eurofins-Experchem, oversees quality assurance in our laboratory. As we like to say, you are safe with Saif.

A Customized Sample Tracking System

Sample-tracking software consists of four main modules:

Tracking samples in our facility: When a sample is booked by our tracking system, a unique identification number is generated by the system and printed on a sticker, which is placed on the sample. When a sample is booked, department heads then have the ability to assign work orders to the analysts through the tracking system.

When testing is complete, results are entered by the analyst into the tracking system and reviewed by the quality assurance (QA) department. QA reviewers are responsible for approving results entered in the system before they are sent to the client. A certificate of analysis is then generated and e-mailed to the client for their review.

Controlling stability studies conducted in our facility: Stability studies are scheduled and controlled on different samples pulled for analysis. Within our facility’s sample-tracking system we have different chamber names with different conditions where products can be placed. Which chamber we place samples in depends on protocols and requests from our client. The software used also generates a unique study number for each stability study that occurs. The stability schedule that includes each study is reviewed every week by the stability coordinator to schedule what samples need to be pulled for testing.

Controlling methods used for tests: Methods are entered into the tracking system after department heads have reviewed them and it is approved by QA. The tracking system generates a unique ID number for each method as well as each sample. The method can now be tracked in our laboratory’s system. Within the software you can enter the name of the method, client name and effective date and any revisions applied to the method.

Controlling inventory of columns and electrodes: Sample tracking also helps us with our purchasing patterns to make sure we have supplies for our client’s testing needs. Every time that columns and electrodes are received, they are entered into our tracking system for inventory purposes.

REES Environmental Monitoring Software

REES is used to monitor the environmental conditions of our testing facility. Key inputs measured include temperature, humidity, differential pressure and elimination or intensity of light. REES is linked to the QA department’s computers. An audible alarm is sounded as well as e-mails sent to QA personnel to notify them if anything is out of specification. REES also phones related personnel’s cell phones to notify them of any alarms. No alarms are missed, even if they occur after working hours. Having a 24-hour environmental monitoring system in place helps Eurofins-Experchem ensure integrity in operations of stability, microbiological and other environmental conditions essential for accuracy in testing results.