A holder of a licence must not sell or export a cannabis product unless testing is conducted by validated methods.
(Validation in Cannabis: Establishing documented evidence that will provide a high degree of assurance that the testing methods must lead to the predetermined specifications and quality consistently and reproducibly results in cannabis.)
Let’s now see what are the regulatory requirements for cannabis validation and why is it important!
Regulatory Requirements for Cannabis Testing
Each mandatory and non-mandatory test must be conducted using validated methods on each lot or batch of cannabis and includes a number of testing requirements. This depends on the cannabis product class as further outlined in the Cannabis Regulations. In addition, a portion of the sample must be kept 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 to enable a determination of whether the lot or batch meets the requirements outlined in the Regulations.
For the following, testing must be conducted on each lot or batch of cannabis, other than cannabis plants or cannabis plant seeds:
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;
The quantity or percentage of THC, THCA, CBD and CBDA, as the case may be.
Licensed holders must also conduct tests on their products, including, as applicable: for microbial and chemical contaminants; for the disintegration of capsules or similar dosage forms of cannabis oil; for residues of solvents; for residues of the content of delta-9-tetrahydrocannabinol (THC), delta-9-tetrahydrocannabinolic acid (THCA), cannabidiol (CBD) and cannabidiol acid (CBDA).
According to Cannabis Act and Regulations:
88 (a) holder of a licence for processing must ensure that:
(c) cannabis and anything that will be used as an ingredient is produced, packaged, labelled, distributed, stored, sampled and tested using methods and procedures that, prior to their implementation, have been approved by the quality assurance person;
(e) every lot or batch of cannabis is approved by the quality assurance person before it is made available for sale by performing;
Third party analytical testing
Using Validated methods approved by the QA
Schedule B of the Food and Drugs Act lists recognized international publications (e.g. European Pharmacopeia (EP)) which set technical specifications for pharmaceutical drugs, herbal medicines, and dietary supplements for the total aerobic microbial count, total combined yeast and moulds count, bile-tolerant gram-negative bacteria, Escherichia coli, and Salmonella, aflatoxin B1, Total aflatoxin. A licence holder must maintain consistent specifications for their products according to these publications, and assess each lot or batch of dried marihuana against those specifications before approving the release of a lot or batch for sale. The quality assurance person has the responsibility to decide on the specifications and methods to be used for testing. The QA must also perform a facility audit of the third-party lab before making a commitment.
A capsule or similar dosage form of cannabis oil that is intended to be swallowed whole or used as a suppository must meet the requirements of a disintegration test that is applicable to the formulation of the capsule or similar dosage form and that is set out in any publication referred to in Schedule B to the Food and Drugs Act. E.g. European Pharmacopeia 8.0, section 2.9.1. Disintegration of tablets and capsules
Solvents – cannabis oil may contain the carrier oil, residues of the solvents listed in the document entitled Limits for Residual Solvents in Cannabis Products, as amended from time to time and published by the Government of Canada on its website that does not exceed the limits established in that document and other substances that are necessary to maintain the oil’s quality and stability.
Cannabis oil must not exceed a maximum yield quantity of 30 mg of THC per mL of the oil taking into account the potential to convert THCa into THC – s.101.
NACPT is a leading career college in Canada that provides in-depth skill training in pharmaceutical, cannabis, business, technology and related fields to maximize the job and business opportunities within the target industries. NACPT has offered specialized Certificate, Graduate and Postgraduate diploma programs in the pharmaceutical and cannabis industries for over ten years. We also offer various cannabis skills training and business incubation programs in the related industries. As a college with affiliations of highly reputable organizations, NACPT provides analytical testing, consulting services and research & development in the pharmaceutical, cannabis and other sectors.
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:
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