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Dr. Ed Askew
From The Lab

Quality Plans for Lab Services: Managing Risks as a Grower, Processor or Dispensary

By Dr. Edward F. Askew
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Dr. Ed Askew

This article is the first in a series that will look into the risks any user of laboratory services (growers, processors or dispensary owners) will face from the quality systems in place in the laboratory. I will discuss specific risk areas in clear and understandable language so as to not obscure the substance of the article series with abbreviations and nomenclature that is not familiar with the reader. Subjects of the articles that follow will focus on the specific laboratory certification or accreditation requirements and how the user may find out if their risks are addressed. As these articles are meant to be interactive with the reader, users are encouraged to send questions or suggested topics to the author.

This article will be an introduction to the typical laboratory process that generates the “paperwork wall” and how it might impact the user.My experience with laboratory certification or accreditation (difference between the two discussed later in this article) comes from over 30+ years in the environmental chemistry field. My experiences include working under the Clean Water Act, Safe Drinking Water Act, FIFRA (pesticides) and ISO 17025 laboratory analyses and laboratory management. I have also received training to perform ISO 17025 and EPA Drinking Water audits. During this time I have been audited as a laboratory analyst/laboratory manager and have performed audits.

As such, I can open up the laboratory structure beyond the sterile “paperwork wall” that has been constructed to allow the user to see the quality of data that is used in final reports that can wreak havoc. This article will be an introduction to the typical laboratory process that generates the “paperwork wall” and how it might impact the user.

One of the common misconceptions that a user has with a “certified or accredited” laboratory is that procession of a certificate indicates that ALL laboratory analyses produced are accurate and precise. I liken this to the “paperwork wall” that laboratories produce when the user questions any results reported to them. The laboratory management assumes that they have answered the user complaint (i.e. a certified/accredited laboratory cannot make a mistake) and the user will not pursue further questions once the certificate is produced.Accreditation does not guarantee that the laboratory personnel can perform the analyses the user is paying for; just that the laboratory’s paperwork has been audited.

First off, let’s look at what the difference between the terms certified laboratory vs. accredited laboratory. These simple words mean specifically different types of laboratories. According to the NIST National Voluntary Laboratory Accreditation Program (NVLAP):

  • Certification is used for verifying that personnel have adequate credentials to practice certain disciplines, as well as for verifying that products meet certain requirements.
  • Accreditation is used to verify that laboratories have an appropriate quality management system and can properly perform certain test methods (e.g., ANSI, ASTM, and ISO test methods) and calibration parameters according to their scopes of accreditation.

So, how does that impact the user?

  • If your state or 3rd party certificate only accredits a laboratory, then the accreditation agency only inspects the laboratory’s quality program as it applies to written documents and static equipment. (e.g. The quality manual is written and the standard operating procedures (SOPs) are in place).
  • Accreditation does not guarantee that the laboratory personnel can perform the analyses the user is paying for; just that the laboratory’s paperwork has been audited.
  • Certification on the other hand says that the laboratory personnel are qualified to perform the laboratory analyses and that the final laboratory results meet specific (certain) requirements. In other words, the laboratory’s quality plan and SOPs are met.

There are three different paths that are utilized by state cannabis control agencies to accredit or certify a cannabis laboratory.

  • ISO 17025: The ISO laboratory quality standard for laboratory accreditation is the most broadly used. ISO 17025 is an international standard and its implementation in the United States is regulated by ILAC. There are three 3rd party companies that audit for and award ISO 17025 accreditation certificates. They are Perry Johnson Laboratory Accreditation Inc., ANAB and A2LA.
  • TNI: The NELAC Institute standards are utilized by one state to handle their cannabis laboratory accreditation.
  • States: Some states have tried to blend an ISO 17025 requirement with their own state’s certification requirements to produce a mixed accreditation-certification program. But, this type of program may rely on two or more agencies (e.g. ISO 17025 3rd party auditors communicating with state auditors) to cover all specific laboratory areas.

PJLAIn two of the paths above, the final result is that the laboratory receives accreditation. That means that only the quality management system and the scope (e.g. SOPS, laboratory instruments, etc.) have been audited, not the laboratory personnel or their capabilities. The third pathway may produce a certified laboratory or may not.

To provide an example of where an accredited laboratory followed their paperwork but produced inadequate results:

  • I received a laboratory report for organic chemical analyses of a client’s process.
    • The laboratory results placed the user in noncompliance with the state and federal regulatory limits.
    • But, the laboratory result contained data flags (e.g. additional information that explains why the laboratory result failed the laboratory’s quality requirements).
    • The laboratory still received payment from the user as the laboratory performed the analyses.
  • I had to explain to the regulatory agency that some of the data flags when investigated showed:
    • The laboratory failed to use the approved analytical method.
    • The detection level for the regulatory chemical was so low that the laboratory had no instrument capable to see those chemicals at the concentrations reported by the laboratory.
  • The state regulators accepted the explanation I provided and the user was no longer under a regulatory administrative order.
  • But, when I presented this information to the accreditation agency that accredited this laboratory I was informed:
    • The laboratory flagged the data so it can be reported to the user.
    • If the user wanted more from the laboratory, then the user will have to outline their specific requirement in a quality contract with the laboratory. (i.e. If the laboratory identifies the problems then they can report the data no matter what happens to the user).

So now, what is being done behind the “paperwork wall”? Areas such as those listed below can impact the results received by the user.

  • Laboratory quality culture: What does the laboratory staff think about quality in their normal daily work?
  • Laboratory staff competence: What is the level of training and real world competence of the staff that actually works on the analyses?
  • Laboratory capabilities: Does the laboratory actually have the laboratory instruments and equipment that can perform the analyses the user needs?
  • Laboratory quality control parameters: What is in the quality manual and does it make sense?
  • Laboratory analytical method validation: Are the analytical methods used by the laboratory validated by approved statistical procedures?

What should the user have in place to limit their risks from laboratory analyses?

  • Failsafe sampling preparation plans: Make sure the user samples for the laboratory are collected correctly.
  • Failsafe’s on laboratory sample reports: Protect the user from bad laboratory reports.
  • User auditing of the laboratory: Go to the laboratory and see if the laboratory can pass muster.

What’s Next: The next article will go behind the laboratory “paperwork wall” to detail the culture that impacts the user results negatively and how that can be recognized. Follow-up articles will help users developing quality plans that identify risks and how to limit them.

EVIO Labs photo

EVIO Labs Expands Ahead of California Testing Deadline

By Aaron G. Biros
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EVIO Labs photo

In a few short weeks, the regulations in California’s cannabis market will expand to include more laboratory testing. The previous exemption for selling untested product will be eliminated come July 1st, meaning that every product on dispensary shelves will have to be tested for a number of contaminants.

EVIO labs photo
Pesticide testing, expanded residual solvent testing and foreign materials testing will be added come July 1st.

According to William Waldrop, chief executive officer and co-founder of EVIO Labs, the state is currently finalizing a revision to the existing emergency rules, which is designed to target the potential supply bottleneck situation. “To help alleviate the bottleneck, the state is eliminating the field duplicate test on every batch of cannabis or cannabis products,” says Waldrop. “This will give the labs additional bandwidth to process more batches for testing.” So one test per batch is the rule now and batch sizes will remain the same. This, of course, is contingent on the state finalizing that revision to the emergency regulations.

William Waldrop, chief executive officer and co-founder of EVIO Labs
William Waldrop, chief executive officer and co-founder of EVIO Labs

In addition to that change, the state will expand the types of testing requirements come July 1st.  New mandatory pesticide testing, expanded residual solvent testing and foreign materials testing are added in addition to the other tests already required.

With July 1st quickly approaching, many in California fear the rules could lead to a major market disruption, such as the previously mentioned bottleneck. Waldrop sees the elimination of duplicate testing as a preventative measure by the state. “It is a good move for the industry because it allows labs to test more batches, hopefully reducing the bottleneck come July,” says Waldrop. Still though, with only 26 licensed laboratories in the state as of March, testing facilities will have to meet higher demand, performing more tests and working with more clients.

EVIO Labs is preparing for this in a number of ways. They already have a lab in Berkeley and are working to expand their capacity for more analyses. In addition to their lab in Berkeley, the company is working to get three more locations operational as quickly as possible. “Right now, EVIO Labs is expanding through the identification of new market locations,” says Waldrop. “We have announced the acquisition of a facility in Humboldt and we are outfitting it for state-mandated testing. We have secured a location in LA, and licensing for LA just began as of June 1stso we are going through the local licensing process at this time. We are still moving through the licensing process for our facility in Costa Mesa as well.”

EVIO Labs photo
Labs will soon have to deal with higher demand, meaning more samples and more clients

“In the meantime, we have expanded capacity of personnel in our Berkeley facility to support our client base until these other locations come online,” says Waldrop. “We are refining our business, bringing on additional equipment and more resources.” While the rules haven’t been implemented yet, Waldrop says he’s seen an uptick in business with licensed operators requesting more testing for the new July 1st standards.

While some might feel a bit panicky about how the new standards could disrupt the market, Waldrop says his clients are looking forward to it. “Our clients are very happy with the proposed new rules, because it reduces the cost of testing per batch, which will inherently reduce wholesale costs, making cannabis more affordable for patients and recreational users.”

Pennsylvania Medical Cannabis Program Blossoms

By Aaron G. Biros
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Pennsylvania’s medical cannabis program may be young, but the industry in that state is off to a burgeoning start. Back in 2016, the state legalized medical cannabis. In 2017, the PA Department of Health began accepting applications for licenses and announced the first 12 winning applications. On February 15th, 2018, medical cannabis became available for more than 17,000 patients that registered in the program.

In March of this year, Governor Tom Wolf announced two more dispensaries were approved to operate as well as another grower/processor licensee. At that time, the press release indicated more than 21,000 patients have registered to participate in the medical cannabis program.

Then in April, Governor Wolf announced Phase Two of their medical cannabis program, allowing the industry to grow even more. That allowed for 13 new grower/processor permits and 23 new primary dispensary permits, according to a press release, which moved the total up to 25 grower/processors licensees and 50 dispensary licensees.

Just weeks later after that announcement, the PA Department of Health adjusted their program to allow patients access to whole plant, dried flower and opened up more qualifying conditions. The qualifying conditions added to the list now include cancer remission therapy as well as opioid-addiction therapy, which are two very notable additions. According to an April 6threport, 28,508 patients and 2495 caregivers registered with the program.

On May 15th, Governor Wolf approved eight universities to participate in a groundbreaking program, allowing Pennsylvania to take the first steps towards clinical research for medical cannabis. This research program would be the first of its kind in the country, allowing research institutions to explore the drug. The excitement was put on hold, however, when a Pennsylvania judge halted the program with an injunction. A handful of growers and dispensary owners in PA filed suit to stop the program on grounds that it violated the original intent of the law. State Representative Kathy Watson from Bucks County, the author of the research program, called the suit “pathetic because it’s all about the money.” We’ll follow closely with any new developments as they come.

Steve Schain, Esq. practicing at the Hoban law Group

Steven Schain, Esq., senior attorney at Hoban Law Group, a global cannabis law firm, represents multiple cannabis-related businesses in Pennsylvania. He says the program’s roll out has been fast with solid growth. “Within two years of the legislation’s enactment, Pennsylvania’s medical marijuana program has exceeded expectations with controlled, sustainable and quality growth,” says Schain. “The Pennsylvania Department of Health established ambitious goals, which they met timely and created a statewide program servicing over 10,000 patients in record time. Looming ahead is New Jersey’s adult use program, the anticipated robustness of which could undermine vigorous sales in southeastern Pennsylvania’s marijuana-related businesses.”

On May 30th, Philadelphia welcomed their first medical cannabis dispensary, with a location opening up their doors to patients in Fishtown. Now reports are coming in that say more than 37,000 patients have registered to date, with over 16,000 who have received their ID cards and medical cannabis at a dispensary.

Even though the research program might be on hold for now, Pennsylvania’s medical cannabis program is growing at a fast pace. The market there has blossomed in just a few short months to a whopping 37,000-registered patients, according to a press release form Governor Wolf’s office. Some say an additional 200,000 patients could qualify. With the second phase in sight, it seems Pennsylvania is on track to become a hotbed for business and research, developing into a massive medical cannabis marketplace soon. Stay tuned for more updates.

Cannabis Report

German Health Insurer Issues First Look at Impact of Medical Cannabis

By Marguerite Arnold
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Cannabis Report

If anyone (read Auslanders) had any illusions that the German take on medical cannabis was going to be casual or unscientific if not painstakingly documented, think again.

Techniker Krankenkasse (or TK as it is referred to by the locals) is one of Germany’s largest public health insurance companies. In other words, it is a private company that is required to provide so called “statutory” health insurance which covers 90% of Germans.

As such, they are also on the front lines now of the medical cannabis debate. Approximately one year after the new law requiring public health insurance companies like TK to reimburse cannabis claims went into effect, the company has just issued what would surely be a best-seller if it were being sold.All of the medical cannabis now being prescribed and reimbursed is coming from abroad.

The Cannabis Report, as it is titled, produced with the help of professors at the University of Bremen, is also the first of its kind. In its pages, along with the corporate summary produced for the recent press conference in Berlin, are several fascinating snapshots of what is going on.

By the numbers.

The Cannabis Report

For those who cannot understand German, this summary by Business Insider is quite educational. Here are the major takeaways: There are now almost 16,000 German patients who are receiving some kind of medical cannabis by prescription. From a doctor. These patients are also paying about $12 for their monthly supplies – even if they have to wait for reimbursement. This is in contrast to the 1,100 patients who managed to obtain cannabis by prescription and pay for it themselves before the law changed last spring.

Do the math and that is a 1,450% uptick. Add in the additional 15,000 left out of this report who are getting cannabis prescribed but their claims turned down, and that is an even more amazing story.

Cannabis ReportHere is the next obvious fact: All of the medical cannabis now being prescribed and reimbursed is coming from abroad. A significant amount is still coming from Holland. The rest? Canada.

For that reason, the cost of medical cannabis is a major concern, along with the medical efficacy of cannabis and the authors’ frustrations about dosing.

The most interesting takeaway? Chronic pain and spasticity arehigh on the list of prescriptions (MS is currently the only condition which is “on label” for cannabis). So is Epilepsy and AIDS. Most interestingly are the high numbers for ADD. This is also highly significant in a country where amphetamine prescriptions for the same are almost unheard of.

TK, like the other health insurers who have started to provide numbers, also approved approximately two thirds of the requests they received. And it has cost them $2.7 million. That bill will begin to reduce as Germany cultivates medical cannabis domestically. However, the tender bid, which now apparently includes 11 contenders, is still undecided, with growing apparently pushed off now until (at the earliest) sometime next summer.

The bottom line, however, in the report from Socium, a university-based think tank that focuses on social inequality, is that cannabis is a drug that should also be treated like any other medication. Even though study authors conclude that so far, they do not find cannabis to be as “effective” as other drugs, they clearly state that the drug does help patients.

An Equally Interesting Industry Snapshot

Flip to page 20, however, and the authors also confirm something else. The top companies providing medical cannabis to German publicly insured patients who are getting reimbursed are Bedrocan, Aurora andCanopy. Aurora’s brands clock in at the highest percentage of THC, although their German importer Pedianos, clearly offers a range of products that start at less than 1% and increase to 22%. MedCann GmbH (renamed Spektrum last year) is essentially providing the rest, and ranges of THC at least, that go from 5.4%-16.5%. They also provide the products with the highest percentages of CBD.

Page 20 of the Cannabis Report produced by TK
Page 20 of the Cannabis Report produced by TK

Unlike the other companies, Canopy’s “brands” are also showing up in ostensibly both medical and government reports (Houndstooth, Penelope, Princeton and Argyle). This is interesting primarily because the German government (and regulatory requirements) tends to genericize medications as much as possible.

Dosing, Impact, Results

The next page of the report is also fascinating. Namely a snapshot of what kind of cannabis is being prescribed and at what doses. Patients who are obtaining cannabis flower are getting up to 3 grams a day. Dronabinol, in stark contrast (which is still the only form of the drug many German patients are able to get), is listed at 30mg.

Unlike any corporate report so far, the study also discusses consumption methods (including, charmingly, tea). It is impossible to forget, reading this, how German and structured this data collection has clearly been. There are several fairly stern referrals to the fact that cannabis should not just be prescribed for “vague” (read psychological) conditions but rather aspecific symptomology (muscle spasms and severe pain).

There is also great interest in how flower differs from pills. And how long the effects last (according to the authors, effects kick in about 2-15 minutes after dosing and last for 4 hours). This is, of course, an accurate picture of what happens to just about every patient, in every country. What is striking, particularly to anyone with an American perspective, is how (refreshingly) clinical much of this basic data collection and discussion is.

And no matter how much the authors call for more research, they clearly have observed that cannabis can have positive, and in many cases, dramatic impacts on patients. According to the handy graphs which are understandable to English speakers, study authors find significant evidence that the drug significantly helps patients with severe pain and or muscle spasms – see MS and Epilepsy, AIDS patients with wasting syndrome and paraplegics (wheelchair bound individuals). Authors list the “strong possibility” that the drug can help with Tourette’s and ADHD. Fascinatingly, however, so far, German researchers are not impressed with the efficacy of the drug for Glaucoma. “Psychological” and psychiatric conditions are also low on the list.

Regardless, this is an important line in the sand. As is the clear evidence that cannabis has efficacy as medication.

The great German cannabis science experiment, in other words, is well underway. And further, already starting to confirm that while many questions remain, and more research is required, this is a drug that is not only here to stay, but now within reach of the vast majority of the population.

Cannabis Micropropagation, Cost Analysis and Viruses

By Cannabis Industry Journal Staff
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Cannabis Cultivation Virtual Conference Part 6

Cannabis Micropropagation, Cost Analysis and Viruses

By Dr. Hope Jones, Chief Scientific Officer of C4 laboratories

  • This presentation will educate the global cannabis industry (including hemp) on tissue culture micropropagation by providing a summary that will show some of the essential concepts behind tissue culture. Virus and pathogen elimination and the importance of a good IPM regime.
  • As well as the economics of the micropropagation industry, design and implementation plans from the small growers to the large in need of understanding the true potential of tissue culture micropropagation, and how to implement and how to avoid costly mistakes.

Every Growroom Has Mold!

By Cannabis Industry Journal Staff
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Cannabis Cultivation Virtual Conference Part 5

Every Growroom Has Mold! Technology Spotlight Sponsored by CannaAirCare

By Ivor Noble, Founder and CEO of CannaAirCare

 

The all natural preventative against airborne mustiness!

Dr. Allison Justice

Exploration and Optimization of Drying and Curing

By Cannabis Industry Journal Staff
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Dr. Allison Justice

Cannabis Cultivation Virtual Conference Part 4

Exploration and Optimization of Drying and Curing

By Dr. Allison Justice, Vice President of Cultivation at Outco

This presentation discusses:

  • Prized French wines are aged for years in oak barrels, as are famous whiskies. Tobacco is air-, fire-, flue- or sun-cured. Cannabis, however, is quickly dried and stored in a plastic bucket. Although many cannabis growers have proprietary ways of making flower flavorful and aromatic, little to no research is available for consistency.
  • Anecdotal examples show that chemical makeup is not only dictated by the strain/cultivar, but also influenced by grow methods, drying and curing. The lack of data prompted us to research what is happening during these processes. In this session, we will present our research at OutCo of how to affect and control the chemical makeup of flower; new protocols to monitor the dry and cure of cannabis flowers so we are able to modulate the terpene and cannabinoid profiles in our strain offering; and our latest findings in this exciting field of post-harvest cannabis research.

Cannabis and the Connected Indoor Farm

By Cannabis Industry Journal Staff
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Cannabis Cultivation Virtual Conference Part 3

Cannabis and the Connected Indoor Farm- Technology Spotlight Sponsored by VividGro

By David Friedman, President of VividGro

This presentation discusses:

  • SMAA- Sensing, monitoring, alerting & automating
  • Hardware & software integration
  • Protecting & using your data

Environmental Monitoring and Greenhouse Controls

By Cannabis Industry Journal Staff
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Cannabis Cultivation Virtual Conference: Part 2

Environmental Monitoring and Greenhouse Controls

By Dr. Nadia Sabeh, Founder/President of Dr. Greenhouse

  • Controlling the environmental parameters of the indoor farm is essential to managing the productivity and health of your crop.
  • This presentation will discuss the critical roles that VPD, airflow, CO2, and other parameters play in the dynamic indoor environment, and we will review different systems and strategies you can use to manage them.
  • A project case study will be presented to demonstrate the costs associated with different climate management (HVAC) alternatives, including first cost, operating cost, maintenance, and crop productivity.

Breeding Cannabis For Unique Therapeutic Benefits

By Cannabis Industry Journal Staff
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Cannabis Cultivation Virtual Conference: Part 1

Breeding Cannabis For Unique Therapeutic Benefits

By Adam Jacques, Co-Founder of Grower’s Guild Gardens, Sproutly

  • This presentation covers topics related to proper breeding procedures, “hunting” particular phenotypes and developing specific cannabinoids and terpenes.
  • Adam highlights some of the major advancements in breeding and how to use available resources to develop a successful breeding program.