The Importance of Analytical Testing to the Evolving Cannabis Marketplace
There is a rapid change in how cannabis is perceived globally! What was once considered a dangerous drug associated with cocaine and heroin, is now accepted for its benefits in therapeutic uses and medicinal properties. As the cannabis industry expands due to decriminalization and legalization of cannabis globally, a growing number of producers will have to meet an expanding market for products.
The need for Quality Control (QC) becomes even more essential to ensure continued growth, standardized products and consumer safety. Just as how foods and drugs are monitored to ensure accurate labelling and free of contaminants, the same concept holds true for cannabis. Some challenges exist in the cannabis industry that set it apart from the food industry, as cannabis is used for medical applications as well as recreational purposes. Cannabis is often consumed via smoking or vaporizing, as well as ingested or applied externally. Inhalation of contaminants entering through the blood poses a greater health danger than digestion. Because of this, cannabis is regulated under both drug and food regulatory bodies.
Within Canada, Health Canada sets out criteria in the Cannabis Act and Regulations, that licensed cannabis producers must meet as a guideline to follow. The Act and Regulations are derived from Good Production Practices guidelines based on Good Manufacturing Practices and require mandatory validated testing conducted on a representative sample of each batch of all legally sold cannabis products. These Health Canada licensed Analytical Testing Labs operate independently as a 3rd party and are employed by Licensed Producers to fulfill the presale Quality Control testing requirements under the Cannabis Regulations. The licensed Testing Labs are required to follow Good Production Practices, Good Laboratory Practices and Good Documentation Procedures as well as the Controlled Drugs and Substances Act. This testing requires specialized analytical instruments, separating and testing techniques to identify and determine the relative amounts of the components in a sample. The QC testing is done by qualified laboratory personnel using testing procedures laid out by pharmacopeias, such as the Canadian Formulary.
The field of analytical chemistry combines qualitative analysis with quantitative analysis. Qualitative analysis determines which substances are in an analytical sample and quantitative analysis determines the quantity of each substance is in the sample. Analytical chemistry plays an important role in the industry, medicine, food, biochemistry, physiology, geology, oceanography, and environmental science.
Current compliance testing requirements for Cannabis products
Testing must be conducted on a representative sample of each lot or batch of cannabis for sale. This testing is a requirement under the Cannabis Regulations, such as testing for microbial, pesticide and chemical contaminants; for dissolution and disintegration; and for quantity or concentration of delta-9-Tim Green Cannabis Compliance and Testing Jan 11, 2021 tetrahydrocannabinol, delta-9-tetrahydrocannabinolic acid, cannabidiol and cannabidiolic acid. A licence holder that requests an analysis must retain a portion of the sample for at least one year after the date of the last sale of any portion of the tested cannabis lot or batch. The retained portion of the sample must be of sufficient quantity to enable a retest.
Analytical Testing Laboratory Requirements
The analytical testing lab plays a crucial role in the quality control of safe cannabis products within the industry. They are the key component for quality control, acting as an independent 3rd party, providing unbiased results of the required testing for the producers. There are several important criteria that the lab must meet to be approved by Health Canada, they are:
The Analytical Testing Lab must have a License obtained from Health Canada to possess cannabis and to obtain cannabis, altering its chemical or physical properties by any means.
The Head of Laboratory must have sufficient knowledge of the provisions of the Act and these Regulations that apply to the holder of the license for analytical testing. They should have the knowledge, training and experience related to the duties. They must possess a science degree related to the work to be carried out.
Qualification of Designation as Analyst must have a degree in a science-related to the work to be performed as well as experience, and training to fulfill the role.
Security requires a physical barrier that prevents unauthorized access to storage areas. Access to each storage area is restricted to individuals whose presence in the area is required by their duties.
Testing conducted by validated methods. A holder of a license must not sell or export a cannabis product unless: Testing must be conducted on each lot or batch of cannabis, other than cannabis plants or cannabis plant seeds.
The quantity or percentage of THC, THCA, CBD and CBDA.
The residues of solvents used in the production of cannabis oil.
The contaminants referred to in section 94 of the cannabis act.
The dissolution or disintegration referred to in section 95 of the Cannabis Act.
A Sample, representative of the batch must be taken and must be retained for at least one year after the date of the last sale of any portion of the batch. The sample must be of sufficient quantity for future testing or investigations. Destruction of samples tested must occur within 90 days after completing the testing. Samples not tested must be destroyed within 120 days.
The lab must have Controlled Drugs and Substances Act (CDSA) license and have SOPs to handle controlled drugs and substances. Only (A)QPIC personnel shall have the access to the vault, which keeps all the controlled substances. The area must be under video surveillance and be equipped with an alarm system.
Every test must be performed by qualified personnel and must be documented in laboratory records and available for review at any time. SOPs must define Personal Protective Equipment (PPE) and gown for the laboratory. SOPs must be in place for OOS (out of specification) investigation procedures and deviations that occur during testing. The testing procedures for each product must be defined in detail in Methods and SOPs and conform to government registered submissions. This includes specifications, defined processes and employed equipment. Each existing and new test method must be validated, any modifications require re-validation.
Records – Quality Assurance, GDP & GLP
All documentation requirements must have SOPs. The information must be recorded at the time of each performed task, signed by the originator, and witnessed when appropriate. Controlled documents must be reviewed and approved by the qualified manager in charge. Documents must be reviewed and approved by QA.
Are they sufficient in ensuring the safety and quality of Cannabis products?
Part 6 of the Cannabis Regulations lists the general provisions for cannabis products. It sets limits on the residues of PCPs for cannabis plants, cannabis plant seeds, fresh cannabis and dried cannabis. For cannabis extracts, cannabis topicals and edible cannabis, the limits on the residues of PCPs are set for the cannabis used to make these products. Health Canada has set Limits of Quantification (LoQ) for pesticide active ingredients in fresh cannabis, cannabis plants and dried cannabis. These limits are based on the identification and quantification of the molecule using analytical methods and equipment.
The laboratory’s LoQ must be equal to or lower than the LoQ set in the Mandatory cannabis testing for pesticide active ingredients. The laboratory must produce and maintain records documenting the results of validation studies. Health Canada may verify these records during inspections.
Provided all the above steps are met, the products are considered safe for use under the limits set by Health Canada.
Common analytical techniques used for Cannabis testing
High Pressure Liquid Chromatography (HPLC) with variable wavelength detector (VWD): can provide an accurate measurement of THC, THCA, CBD and CBD.
Gas Chromatography (GC) with flame ionization detector (FID): identifies individual percentages of each terpene profile.
Residual Solvents Analysis
Gas Chromatography (GC) with flame ionization detector (FID): displays the analysis in parts per million (ppm).
At NACPT Pharma College, we have worked hard with both the Canadian government and cannabis industry experts to fill the need of educating those who wish to have a successful career as cannabis Quality Assurance Person (QAP).
For those interested in learning more about cannabis analytical testing requirements, Cannabis Quality Control and Quality Assurance, we invite you to our 1-4 days – comprehensive certification training – Online Interactive Instructor Led Webinar:
All training classes are moved to both online (live interactive webinar) and onsite training mode due to COVID-19 pandemic as of March 18, 2020. Please contact us for more details.
Due to COVID-19, all training programs will be held online (live, interactive, and instructor-led) until further notice. Hybrid Learning Mode will be used for programs that include hands-on training (theory will be delivered online and hands-on training will be delivered on-site). Students who wish to receive onsite instruction should contact the college. Please get in touch with us for more information!