PART 5Good Production Practices
Marginal note:Sale, distribution and exportation
79 A holder of a licence must not sell, distribute or export cannabis unless the applicable requirements set out in sections 80 to 88 have been met.
Marginal note:Standard operating procedures
80 Cannabis must be produced, packaged, labelled, distributed, stored, sampled and tested in accordance with standard operating procedures that are designed to ensure that those activities are conducted in accordance with the requirements of this Part.
Marginal note:Pest control product
82 Cannabis must be stored under conditions that maintain its quality.
83 Cannabis must be distributed in a manner that maintains its quality.
Marginal note:Building or part of building
84 (1) Cannabis must be produced, packaged, labelled, stored, sampled and tested in a building or part of a building that is designed, constructed and maintained in a manner that permits those activities to be conducted appropriately and under sanitary conditions, and in particular that
(2) Despite subsection (1), cannabis may be obtained by cultivating, propagating or harvesting it outdoors.
Marginal note:Filtration of air
85 The building or part of the building where cannabis is produced, packaged, labelled and stored must be equipped with a system that filters air to prevent the escape of odours.
(2) Paragraph 1(d) does not apply to the outdoor cultivation, propagation or harvesting of cannabis.
Marginal note:Sanitation program
(a) procedures for effectively cleaning the building or part of the building in which those activities are conducted;
(b) procedures for effectively cleaning the equipment used in those activities;
(c) procedures for handling any substance used in those activities; and
(d) all requirements, in respect of the health and hygienic behaviour of the personnel who are involved in those activities, that are necessary to ensure that those activities are conducted in sanitary conditions.
(2) Paragraph (1)(a) does not apply to the outdoor cultivation, propagation or harvesting of cannabis.
Marginal note:Quality assurance
88 (1) In the case of a holder of a licence for processing, every complaint received in respect of the quality of the cannabis must be investigated by the quality assurance person referred to in section 19 who must, if necessary, take corrective and preventative measures.
Marginal note:Methods and procedures
(2) In the case of a holder of a licence for processing, the cannabis must be produced, packaged, labelled, distributed, stored, sampled and tested using methods and procedures that, prior to their implementation, have been approved by a quality assurance person.
Marginal note:Approval prior to sale
(3) In the case of a holder of a licence for processing, every lot or batch of cannabis must be approved by a quality assurance person before it is made available for sale.
Marginal note:Sale and exportation — cannabis product
89 A holder of a licence must not sell or export a cannabis product unless the applicable requirements set out in sections 90 to 92 have been met.
Marginal note:Validated methods
90 The testing conducted under section 91 and further to the requirements in Part 6 must be conducted using validated methods.
91 Testing for the following must be conducted on each lot or batch of cannabis, other than cannabis plants or cannabis plant seeds, that will become a cannabis product or that will be contained in a cannabis accessory that is a cannabis product:
(a) the residues of solvents used in the production of cannabis oil;
(b) the contaminants referred to in section 94;
(c) the dissolution or disintegration referred to in section 95; and
(d) the quantity or percentage of THC, THCA, CBD and CBDA, as the case may be.
Marginal note:Representative sample
(2) A portion of the sample referred to in subsection (1) 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 to enable a determination of
PART 6Cannabis Products
Marginal note:Maximum residue limit
(2) Despite subsection (1), the cannabis may contain residues of a pest control product, its components or derivatives, if they do not exceed any maximum residue limit, in relation to cannabis, specified for the pest control product, its components or derivatives under section 9 or 10 of the Pest Control Products Act.
Marginal note:Cannabis oil
(3) Despite subsection (1), 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.
Marginal note:Microbial and chemical contaminants
94 (1) Despite subsection 93(1), cannabis that is a cannabis product or that is contained in a cannabis accessory that is a cannabis product may contain microbial or chemical contaminants provided that they are within generally accepted tolerance limits for herbal medicines for human consumption, as established in any publication referred to in Schedule B to the Food and Drugs Act.
Marginal note:Non-application — cannabis plant or cannabis plant seeds
(2) The tolerance limits referred to in subsection (1) do not apply to a cannabis product that is a cannabis plant or cannabis plant seeds.
Marginal note:Dissolution and disintegration
95 Each discrete unit of a cannabis product that is intended to be administered orally, rectally or vaginally must meet the requirements of a dissolution or disintegration test that is applicable to its formulation and that is set out in any publication referred to in Schedule B to the Food and Drugs Act.
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