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Cannabis Compliance Testing

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By Neil Garland, January 10th, 2021 – Health Canada regulatory testing requirements under the Cannabis Act and Regulations for Licensed Producers and Analytical Laboratories.

Introduction

Licensed Analytical Testing Laboratory’s (Labs) perform compliance testing for Licensed Producers of Cannabis in Canada. This is a requirement of the Cannabis Act and Regulations for compliance testing, in which these third-party Labs perform Quality Control (QC) Testing to quantify and verify finished cannabis products. Testing must be conducted using validated methods. The Analytical Chemist performing the work is fulfilling the Licensed Producer’s obligation for Quality Control Procedures. Over the years, the requirements for an acceptable cannabis assay have drastically changed. Until cannabis legalization, the focus has been on the quantification of 9-tetrahydrocannabinol (THC) and Cannabinoidal (CBD). With legalization in Canada and the certain States of America, intensive research and innovations over the past several decades have successfully identified 483 compounds, including over 150 unique cannabinoids and 140 terpenes members. Quality Control is an essential part of the success of the cannabis industry.

Key challenges exist in the cannabis industry that set it apart from other industries, such as the food industry. Even though similarities exist, cannabis is used for medical applications. Medical patients often have weakened immune systems and are children or the elderly. Vulnerable people require protection and Quality Control Testing to rigorous standards for the safety and quality of cannabis products are even more important. Another key challenge is the fact, cannabis is very often consumed by smoking or vaporizing. Contaminants entering the blood through inhalation pose a greater health danger than digestion. Not enough is known on these consequences, more studies need to be conducted. As the industry becomes more sophisticated, so too do the products. Novel products pose many challenges for analytical labs, from tracking the stability of novel water-based formulations to assessing the risk from heavy metals in packaging. Methods and procedures for testing these new products will have to be created. Moreover, regulatory requirements and validated testing methods can create their own sets of challenges. More validated methods are being created, however, it’s quite common for labs to set up their own in-house validated testing methods and procedures, which require superior chemist ability and company resources.

Background

Analytical chemistry is the art and science of separation and identification to provide the qualitative and quantitative analysis of individual structure and matter in a structure. This chemistry deploys quantitative analysis by the study of the substance which is being analyzed, the “analyte”. Analytical chemistry involves a powerful set of ideas, methods, and instrumentation. Various techniques can be deployed to identify the matter to determine the concentration of the substance present in the analyte. Analytical chemists use their knowledge of chemistry, instrumentation, computers, and statistics to solve problems in almost all areas of chemistry and for all kinds of industries. Analytical chemistry provides a very important role in society. It serves great importance in different research areas, process control in industry, engineering fields, environmental monitoring, medicine/medical diagnostics, food production, and forensic studies.

Discussion

What are the current compliance testing requirements?

License holders under the Cannabis Regulations have an obligation to meet the mandatory testing requirements:

  1. The requirements of the Pest Control Products Act and the Cannabis Act related to the use of pest control products (PCPs) are met.
  2. Individuals have access to quality-controlled cannabis products that have not been treated or contaminated with unauthorized PCPs.
  3. Individuals have accessible and accurate information so they can make informed decisions.

In order to meet these mandatory testing requirements, license holders under the Cannabis Regulations must demonstrate that none of the unauthorized pesticide active ingredients, as a list in the “Mandatory cannabis testing for pesticide active ingredient’s- Lists and Limits” published by Health Canada, are used to treat cannabis or have contaminated it. This list includes the set limits of quantification (LOQ) for pesticide active ingredient’s in fresh cannabis, cannabis plants, and dried cannabis. The limits are based on the identification and quantification of the molecule using current chemical analytical methods and equipment. The Health Canada Guidance Document for “Mandatory cannabis testing for pesticide active ingredient’s- Requirements” must be used in conjunction with the “Mandatory cannabis testing for pesticides active ingredients-lists and limits.”

Testing

The regulatory requirements state a license holder must not sell or export a cannabis product unless: Testing must be conducted by validated methods by a neutral third-party Licensed Testing Laboratory. The following testing must be conducted on each lot or batch of cannabis (excluding cannabis plants or seeds):

  1. The residues of solvents used in the production of cannabis oil;
  2. The contaminants referred to in section 94 of the act;
  3. The dissolution or disintegration referred to in section 95 of the Cannabis Act; and
  4. The quantity or percentage of THC, THCA, CBD, and CBDA.

Samples

  1. A representative sample of the lot or batch must be taken.
  2. A portion of the sample must be retained for at least one year after the date of the last sale of any portion of the lot or batch and must be of sufficient quantity for Testing and investigations.

Laboratory Controls

  1. SOPS must define personal protective equipment (PPE) and gowning for the laboratory.
  2. Testing procedures for each product must be defined in detail in Methods and SOPs and conform to government registered submissions: including specifications, defined processes, and employed equipment.
  3. Each existing and new test method must be validated.
  4. Re-validation or verification must be performed post modification: This includes raw materials, equipment, test procedures, and laboratory site.
  5. Each Method and specification must have a unique identifier following defined SOPs.
  6. All testing must be performed by trained personnel.
  7. Each test performed must be documented in laboratory records and available for review at any time.
  8. Each test solution prepared must be labeled with identification, date prepared expiry date, and initialed.
  9. SOPS must be in place for OOS (out of specification) investigation procedures.
  10. SOPs must define the actions for any exceptions and deviations that occur during testing. Unplanned deviation could be dealt with case by case and may be acceptable based on the different scenarios.
  11. SOPs or detailed procedures to handle controlled drugs and substances.
  12. Only (A)QPIC personnel shall have the access to the vault that secures all controlled substances and is responsible for distributing substances to analysts and putting them back in the vault in a timely manner.
  13. Vault must be: under video surveillance, equipped with an alarm system.

Are they sufficient in ensuring the safety and quality of Cannabis Products?

Currently, Health Canada only uses guidance documents, included within, is a list of known substances requiring to be tested for their presence and if they fall under the acceptable limits set out. This fails to eliminate the known contamination/substance from the product. The safety and quality of cannabis products can only be ensured if all of the dangerous compounds are known and tested for. An example of a cannabis product where complete testing cannot be achieved is THC distillates. THC distillates when tested on average show 90% THC and 5% other cannabinoids respectively. However, what is the other 5% of the mixture? To date, those substances have yet to be identified on whether or not they are safe. Other challenges, the guidance documents fail to address the factor of what happens in practice and what can be easily audited. Testing variability due to human error (not following the requirements), unqualified staff, or inadequate equipment can and are occurring. Since contaminates are permitted by Health Canada, more needs to be done to achieve the elimination of any substances that prove harmful within cannabis products.

What are common analytical techniques used for cannabis testing?

Cannabinoid Analysis High-Pressure Liquid Chromatography (HPLC) with variable wavelength detector: can provide an accurate measurement of THC, THCA, CBD, and CBD (VWD).

Common Analytical Techniques Continued:

Terpene Analysis- Gas Chromatography with Head Space (FID): identifies individual percentages of each terpene profile.

Aflatoxins B1, B2, G1, G2 Analysis- HPLC with Fluorescence Detector: displays the analysis in parts per billion (ppb).

Residual Solvents Analysis- Gas Chromatography (GC) with Head Space (FID): displays the analysis in parts per million (ppm).

Pesticides Analysis- Gas Chromatography-Mass Chromatography (GC-MS): preferred method since mass detector has increased certainty of analyte identification.

Microbiology Analysis- Pathogens detection with Aerobic Plate Count and Yeast and Mold Count.

Heavy Metals Analysis- Inductively coupled plasma mass spectrometry (ICP-MS): displays great speed, precision, and sensitivity.

What active ingredients are generally tested for the safety and efficacy of the cannabis product?

Active ingredients being tested for: THC, THCA, THCV, CBC, CBG, Heavy metals, Pesticides, Aflatoxins, Residual Solvents, Microbial Content, and Terpenes (not a mandatory test).

Conclusion

A large number of papers on the topic of analytical chemistry do exist. However, when an industry is in its infancy, the protocols and standards are too. As the cannabis industry as a whole progresses, so too will the knowledge of what is harmful, what is present in cannabis (what we don’t know now, which is a lot) and all the acceptable criteria and limits of quantification still need to be discovered and set-in place for the undiscovered. The regulatory guidance documents are a healthy start the beginning of something much larger. It begins the process of establishing standards devised to protect the medical patient or consumer. Since the guidance documents are just that, “guidance”, and permits acceptable limits of harmful substances. Further discussion, research, and information sharing, such as the approach of a “public statistical database” need to occur to advance the industry forward. This holistic approach called metabolomics at a system level could incorporate all of these principles.

References

  1. Catherine Shaffer, et al. “Medical Cannabis Poses Unique Testing Challenges.” GEN, 20 Aug. 2019, www.genengnews.com/insights/medical-cannabi-poses-unique-testing-challenges/.
  2. Bob Clifford General Manager of Marketing Shimadzu Scientific Instruments Dr. Robert (Bob) Clifford received his Bachelor’s degree from Glassboro State College. “Analytical Instruments You Need to Start a Cannabis Testing Laboratory.” Cannabis Industry Journal, Cannabis Industry Journal, 27 Sept. 2019, cannabisindustryjournal.com/feature-article/analytical-instruments-you-need-to-start-a-cannabis-testing-laboratory/.
  3. Branch, Legislative Services. “Consolidated Federal Laws of Canada, Cannabis Regulations.” Cannabis Regulations, Government of Canada, 7 Jan. 2021, laws-lois.justice.gc.ca/eng/Regulations/SOR-2018-144/index.html.
  4. Canada, Health. “Government of Canada.” Canada.ca, / Government Du Canada, 4 Dec. 2019, www.canada.ca/en/health-canada/services/cannabis-regulations-licensed-producers/good-production-practices-guide/guidance-document.html.
  5. Canada, Public Health Agency of. “Government of Canada.” Canada.ca, / Government Du Canada, 4 Dec. 2019, www.canada.ca/en/public-health/services/publications/drugs-health-products/cannabis-testing-pesticide-requirements.html.
  6. “The Cannabis Industry: An Analytical Chemists Dream and Nightmare.” Cannabis Science Tech, www.cannabissciencetech.com/view/cannabis-industry-analytical-chemists-dream-and-nightmare.
  7. The Cannabis Scientist. “What’s Next for Cannabis Analysis?” The Cannabis Scientist, 17 Sept. 2020, thecannabisscientist.com/testing-processing/what’s-next-for-cannabis-analysis.
  8. David, and David. “Leaner and Greener Analysis of Cannabinoids.” Www.thctotalhealthcare.com, 27 Feb. 2017, www.thctotalhealthcare.com/leaner-and-greener-analysis-of-cannabinoids/.
  9. Mudge, Elizabeth M., etal. “Leaner and Greener Analysis of Cannabinoids.” Analytical and Bioanalytical Chemistry, vol. 409, no. 12, 2017, pp. 3153–3163., doi:10.1007/s00216-017-0256-3.
  10. Aizpurua- Olaizola, J. Omar, et al. “Methods for Quantification of Cannabinoids: a Narrative Review.” Journal of Cannabis Research, BioMed Central, 1 Jan. 1970, jcannabisresearch.biomedcentral.com/articles/10.1186/s42238-020-00040-2.
  11. Thomas, Dr. Liji. “Analytical Chemistry Techniques.” News, 26 Feb. 2019, www.news-medical.net/life-sciences/Analytical-Chemistry-Techniques.aspx.

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