A holder of a licence must not sell or export a cannabis product unless: Testing conducted by validated methods. (Validation means 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.)
Testing Regulatory Requirements: Testing for the following must be conducted on each lot or batch of cannabis, other than cannabis plants or cannabis plant seeds
88 (a) holder of a licence for processing must ensure that:
(c) cannabis and anything that will be used as an ingredient are 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;
Each mandatory and non mandatory test must be conducted using validated methods. Must be conducted on each lot or batch of cannabis and include a number of testing requirements depending 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.
Licensed holders must conduct tests on their products, including, as applicable: for microbial and chemical contaminants; for 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).
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. 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 do 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.
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