Guidance document: Good production practices guide for cannabis

Organization: Health Canada

Published: August 29, 2019

Table of contents

• 1.0 Purpose
• 2.0 Background
• 3.0 Scope
• 4.0 Definitions and abbreviations
  • 4.1 Definitions
  • 4.2 Abbreviations
  • 4.3 Icons
• 5.0 Good production practices: Regulatory requirements
  • 5.1 General requirements
    • 5.1.1 Standard operating procedures
    • 5.1.2 Pest control products, sanitizers, agronomic inputs and non-food chemical agents
      • 5.1.2.1 Pest control product
      • 5.1.2.2 Sanitizers, agronomic inputs and non-food chemical agents
    • 5.1.3 Storage and distribution
      • 5.1.3.1 Storage
      • 5.1.3.2 Distribution
    • 5.1.4 Building/part of a building
    • 5.1.5 System - filtration and ventilation, supply of water, and lighting
      • 5.1.5.1 System - filtration and ventilation
      • 5.1.5.2 Supply of water
      • 5.1.5.3 Lighting
    • 5.1.6 Equipment
    • 5.1.7 Sanitation
      • 5.1.7.1 Sanitation program
      • 5.1.7.2 Hand cleaning and hand sanitizing stations and lavatories
  • 5.2 Additional requirements - Holder of a licence for processing
    • 5.2.1 Quality assurance
    • 5.2.2 Competencies and Qualifications
    • 5.2.3 Temperature and humidity, heating, cooling or humidity-control system
    • 5.2.4 Incompatible activities
    • 5.2.5 Separation of cannabis and ingredients from contaminants
    • 5.2.6 Ingredient-related risk of injury to human health
    • 5.2.7 Potable water
    • 5.2.8 No presence of animals
    • 5.2.9 Land-related risk of contamination
    • 5.2.10 Removal and disposal of contaminated materials and waste
    • 5.2.11 Conveyances and equipment
    • 5.2.12 Clothing, footwear and protective coverings
    • 5.2.13 Identification and analysis of hazards - Prevention, elimination and reduction of hazards
    • 5.2.14 Preventive control plan
  • 5.3 Testing requirements
    • 5.3.1 Testing Requirements
      • 5.3.1.1 Testing for phytocannabinoids
      • 5.3.1.2 Testing for contaminants
      • 5.3.1.3 Dissolution and disintegration testing
      • 5.3.1.4 Testing method
    • 5.3.2 Representative sample and quantity
  • 6.0 Contact us
  • 7.0 Feedback-Help us improve
  • Appendix A: GPP requirements by licence class
  • Appendix B: GPP requirements by class of cannabis
  • Appendix C: Part 2 - Licensing requirements related to GPP
  • Appendix D: Part 6 - Cannabis products requirements related to GPP
  • Appendix E: Part 11 - Retention of documents and information requirements related to GPP
  • Appendix F: Preventive control plan best practices

1.0 Purpose

This document provides guidance to federally regulated holders of a licence under the Cannabis Act ("licence holders") on the application of Part 5: Good Production Practices (GPP) of the Cannabis Regulations. It is designed to help licence holders understand the GPP requirements for cannabis that is produced, packaged, labelled, distributed, stored, sampled, tested and sold in Canada, as well as cannabis that is to be exported from Canada.

2.0 Background

The Cannabis Act (hereafter referred to as "the Act") and its Regulations provide, among other things, the framework for legal access to cannabis and the control and regulation of its production, distribution and sale.

Part 5 of the Cannabis Regulations addresses the GPP requirements that are designed to help ensure that cannabis meets quality standards appropriate to its intended use. These standards and other requirements are backed by rigorous compliance and enforcement measures by Health Canada, including unannounced inspections where inspectors verify adherence to the regulations.

When Health Canada finds a licence holder to be non-compliant with any or all of the requirements in Part 5 of the Cannabis Regulations, a range of compliance and enforcement measures may be taken, such as:

• Issuance of a warning letter
• Issuance of public advisories or other forms of risk communications
• Seizure or detention
• Refusal, suspension or revocation of an authorization, including a licence or permit
• Issuance of an administrative monetary penalty of up to $1 million
• Issuance of a ministerial order to recall products from the market, conduct tests or studies, produce information or documents or take other measures

For more information on compliance and enforcement measures, refer to the Compliance and enforcement policy for the Cannabis Act on Health Canada's website.

Guidance documents are administrative instruments not having force of law and, as such, allow for flexibility in approach. This guide is one of a series of guidance documents written as an accompaniment to the Cannabis Regulations under the Act. Health Canada publishes other guidance documents and information on its website that licence holders may use in conjunction with this document to maintain their compliance. For consistency and transparency, this guide and other guidance documents and information are updated as required to reflect changes to policies or operations.

3.0 Scope

This guide pertains to federally licensed production activities (including production, packaging, labelling, distribution, storage, sampling and testing) conducted with cannabis by licence holders, and the compliance of those licence holders with the GPP requirements set out in Part 5 of the Cannabis Regulations.

As per section 3 of the Cannabis Regulations, the GPP requirements do not apply to the holder of a cannabis drug licence.

The scope of this guide includes the following classes of cannabis, as set out in Schedule 4 of the Act:

• Dried cannabis
• Fresh cannabis
• Cannabis plants
• Cannabis plant seeds
• Edible cannabis
• Cannabis extracts
• Cannabis topicals

In accordance with the Cannabis Regulations, the GPP regulatory requirements outlined in this guide are broken down as follows:

• General Requirements: Applies to all cannabis, including all classes of cannabis, all cannabis products of those classes, and all things that will be considered as ingredients that are to be sold, distributed or exported by a licence holder other than a holder of a licence for analytical testing or a holder of a licence for research.
• Additional Requirements - Holder of a licence for processing: Applies to cannabis and anything that will be used as an ingredient that is to be sold, distributed or exported by a holder of a licence for processing.
• Testing Requirements: Applies to cannabis within the following classes: dried cannabis, fresh cannabis, edible cannabis, cannabis extracts, and cannabis topicals.

Additionally, the appendices provide information on additional requirements outlined in other parts of the Cannabis Regulations as they pertain to GPP, namely Part 2: Licensing, Part 6: Cannabis Products, and Part 11: Retention of Documents and Information.

4.0 Definitions and abbreviations

4.1 Definitions

The Cannabis Act and its Regulations should be referred to for definitions. Some definitions that appear in the Act or in the Regulations are included in this section for ease of reference, and others appear for the purpose of the guide.

Acceptable level:

As defined in subsection 78(1) of the Cannabis Regulations, means a level of a biological, chemical or physical hazard that does not present a risk of contamination of the cannabis or anything that will be used as an ingredient.

Adverse reaction:

As defined in subsection 248(3) of the Cannabis Regulations, means a noxious and unintended response to a cannabis product.

Agronomic input:

An input that is used in growing of cannabis or an ingredient, and includes agricultural chemicals, biological controls, pollinators, commercial fertilizers, compost, compost tea, green manure, manure, mulch, row covers, soil amendments and pulp sludge.

Bulk cannabis:

Any cannabis that has not yet been packaged as a cannabis product.

Cannabis:

As defined in subsection 2(1) of the Act, means a cannabis plant and anything referred to in Schedule 1 of the Act, but does not include anything referred to in Schedule 2 of the Act. For the purpose of this guide, the term cannabis includes any class of cannabis listed in Schedule 4 to the Act, as well as any cannabis accessory that contains cannabis, a discrete unit of cannabis, or a cannabis product.

Cannabis accessory:

As defined in subsection 2(1) of the Act, means:

1. A thing, including rolling papers or wraps, holders, pipes, water pipes, bongs and vaporizers, that is represented to be used in the consumption of cannabis; or
2. A thing that is deemed under subsection 3 to be represented to be used in the consumption of cannabis.

Cannabis extract:

As defined in subsection 1(1) of the Cannabis Regulations, means,

1. a substance produced by
   1. subjecting anything referred to in item 1 of Schedule 1 to the Act to extraction processing;
      or
   2. synthesizing a substance that is identical to a phytocannabinoid produced by, or found in, a cannabis plant; or

2. a substance or mixture of substances that contains or has on it a substance produced in a manner referred to in paragraph (a).

   It does not include a cannabis topical or edible cannabis.

Cannabis plant

As defined in subsection 2(1) of the Act, means a plant that belongs to the genus Cannabis.

Cannabis plant seed:

A seed of a cannabis plant.

Cannabis product:

As defined in subsection 1(2) of the Cannabis Regulations, means cannabis of only one of the classes set out in Schedule 4 to the Act-or a cannabis accessory if that accessory contains such cannabis-after it has been packaged and labelled for sale to a consumer at the retail level. It does not include cannabis intended for an animal, a cannabis accessory that contains cannabis that is intended for an animal, or a drug containing cannabis.

Cannabis topical:

As defined in subsection 1(1) of the Cannabis Regulations, means a substance or mixture of substances that contains or has on it anything referred to in item 1 or 3 of Schedule 1 to the Act and that is intended for use, directly or indirectly, exclusively on external body surfaces, including hair and nails.

Class of cannabis:

Any one of the classes outlined in Schedule 4 to the Act (i.e. dried cannabis, fresh cannabis, cannabis plants, cannabis plant seeds, edible cannabis, cannabis extracts, or cannabis topicals).

Contaminated:

As defined in subsection 1(2) of the Cannabis Regulations, means, in respect of cannabis, a cannabis accessory or an ingredient, containing or having on it anything - including a micro-organism but excluding anything referred to in item 1 or 3 of Schedule 1 to the Act - that may render the cannabis or ingredient injurious to human health or unsuitable for human use.

Control measure:

As defined in subsection 78.1 of the Cannabis Regulations, means a measure that can be applied to prevent or eliminate any biological, chemical or physical hazard that presents a risk of contamination of the cannabis or anything that will be used as an ingredient, or to reduce the hazard to an acceptable level.

Critical control point:

A step at which the application of a control measure is essential to prevent or eliminate any biological, chemical or physical hazard that presents a risk of contamination of the cannabis or anything that will be used as an ingredient, or to reduce the hazard to an acceptable level.

Discrete unit:

Refers to, in the case where a single immediate container contains more than 1 unit of a cannabis product, each of those units. Examples could include multiple pre-rolled joints, capsules, separate edible pieces, etc.

Dried cannabis:

As defined in subsection 2(1) of the Act, means any part of a cannabis plant that has been subjected to a drying process, other than seeds.

Edible cannabis:

As defined in subsection 1(1) of the Cannabis Regulations, means a substance or mixture of a substance that contains or has on it anything referred to in item 1 or 3 of Schedule 1 to the Act and that is intended to be consumed in the same manner as food. It does not include dried cannabis, fresh cannabis, cannabis plants or cannabis plant seeds.

Extraneous substances:

For the purpose of this guide, means anything other than cannabis intended to be distributed, sold or exported, but does not include contaminants.

Food:

As defined in subsection 1(2) of the Cannabis Regulations, has the same meaning as in section 2 of the Food and Drugs Act.

Food additive:

As defined in subsection 1(2) of the Cannabis Regulations, means any substance the use of which results, or may reasonably be expected to result, in it or its by-products becoming a part of, or affecting the characteristics of, a food or edible cannabis, but does not include anything referred to in item 1 or 3 of Schedule 1 to the Cannabis Act; or anything that is excluded from the definition food additive in subsection B.01.001(1) of the Food and Drug Regulations.

Food allergen:

As defined in section 105 of the Cannabis Regulations, has the same meaning as in subsection B.01.010.1(1) of the Food and Drugs Regulations.

Fresh cannabis:

As defined in subsection 1(1) of the Cannabis Regulations, means freshly harvested cannabis buds and leaves, but does not include plant material that can be used to propagate cannabis.

Immediate container:

As defined in subsection 1(2) of the Cannabis Regulations, means the container that is in direct contact with cannabis that is a cannabis product or - if a wrapper is in direct contact with the cannabis - with the wrapper.

Ingredient:

As defined in subsection 1(2) of the Cannabis Regulations, means

1. in the case of a cannabis extract or cannabis topical, a substance, other than a substance referred to in item 1 or 3 of Schedule 1 to the Act, that is intended to be present in the final form of the cannabis extract or cannabis topical; and
2. in the case of edible cannabis,
   1. a substance, other than a substance referred to in item 1 or 3 of Schedule 1 to the Act,
      1. that is used to make the edible cannabis where the use results, or may reasonably be expected to result, in the substance or its by-products becoming a part of, or affecting the characteristics of, the edible cannabis, or
      2. that is part of a mixture of substances referred to in item 2 of the Schedule that is used to make the edible cannabis where the use results, or may reasonably be expected to result, in the substance or its by-products becoming a part of, or affecting the characteristics of, the edible cannabis, or
   2. a mixture of substances, other than a mixture of substances that are referred to in item 1 or 3 of Schedule 1 to the Act,
      1. that is used to make the edible cannabis where the use results, or may reasonably be expected to result, in the mixture or its by-products becoming a part of, or affecting the characteristics of, the edible cannabis, or
      2. that is part of a mixture of substances referred to in item 2 of the Schedule that is used to make the edible cannabis where the use results, or may reasonably be expected to result, in the first mixture or its by-products becoming a part of, or affecting the characteristics of, the edible cannabis.

Licence holder:

The holder of a licence, as listed in section 8 of the Cannabis Regulations.

Non-food chemical agents:

Chemicals at the site that are not considered to be cannabis, a food or an ingredient, including cleaning chemicals, detergents, lubricants, petroleum products, and pest control products.

Pest control product:

As defined in subsection 1(2) of the Cannabis Regulations, has the same meaning as in subsection 2(1) of the Pest Control Products Act. In addition, for the purposes of this guide, a pest control product may either have been authorized for use on cannabis specifically, or have been authorized for use on crops more generally, or alternatively, an individual may seek an authorization under section 10 of the Pest Control Products Act specific to their production.

Produce:

As defined in subsection 2(1) of the Act, means to obtain cannabis by any method or process, including by:

• manufacturing;
• synthesis;
• altering its chemical or physical properties by any means; or
• cultivating, propagating or harvesting it or any living thing from which it may be extracted or otherwise obtained

Sanitary condition:

As defined in section 78.1 of the Cannabis Regulations, means a condition that does not present a risk of contamination, allergen cross-contamination or introduction of an extraneous substance to the cannabis or anything that will be used as an ingredient.

Serious adverse reaction:

As defined in subsection 248(3) of the Cannabis Regulations, means a noxious and unintended response to a cannabis product that requires inpatient hospitalization or a prolongation of existing hospitalization, causes congenital malformation, results in persistent or significant disability or incapacity, is life threatening or results in death.

Validation:

Establishing documented evidence that will provide a high degree of assurance that the testing methods will consistently, and reproducibly, lead to the predetermined specifications and quality results in tested cannabis.

4.2 Abbreviations

CBD

cannabidiol

CBDA

cannabidiolic acid

FDA

Food and Drugs Act

GPP

good production practices

OOS

out-of-specification

Part 5

Good Production Practices of the Cannabis Regulations

Part 6

Cannabis Products of the Cannabis Regulations

Part 11

Retention of Documents and Information of the Cannabis Regulations

PCPA

Pest Control Products Act

QAP

quality assurance person

SOP

standard operating procedure

s.

section number in the Cannabis Regulations

THC

delta-9-tetrahydrocannabinol

THCA

delta-9-tetrahydrocannabinolic acid

The Act

the Cannabis Act

4.3 Icons

The following icons are used throughout this guide to highlight information of interest.

5.0 Good production practices: Regulatory requirements

Part 5 of the Cannabis Regulations requires licence holders to follow GPP to help ensure cannabis is produced consistently and that all activities conducted by licence holders with cannabis meet quality standards appropriate to the intended use of the cannabis.

Section 5 of this guide is organized into three sections:

• Section 5.1: General requirements that must be met in order to sell, distribute or export any cannabis.
• Section 5.2: Additional requirements that must be met by a holder of a licence for processing in order to sell, distribute or export cannabis.
• Section 5.3: Testing requirements that must be met in order to sell or export cannabis products.

Additionally, GPP-related requirements set out in Part 2: Licensing, Part 6: Cannabis Products, and Part 11: Retention of Documents and Information of the Cannabis Regulations are included as accompanying information in the appendices.

Licence holders are responsible for understanding and complying with all GPP requirements that apply to their class of licence and range of authorized activities. They must be able to demonstrate that cannabis has been produced, distributed and sold in accordance with the Cannabis Regulations.

Appendix A and Appendix B provide a summary of the GPP requirements by licence class and class of cannabis, respectively.

5.1 General requirements

As per section 79 of the Cannabis Regulations, licence holders must not sell, distribute or export cannabis unless the requirements set out in sections 80 to 88.94 of the Cannabis Regulations applicable to the activities they conduct have been met. As per section 79.1 of the Cannabis Regulations, the requirements of Part 5 do not apply to any activity that a person conducts in respect of anything that will be used as an ingredient unless the activity is conducted by a licence holder. Despite this section 79.1, licence holders are still responsible for ensuring that the final product, which may contain ingredients from a non-licence holder, is in compliance with the Cannabis Regulations. Furthermore, as per section 79.2 of the Cannabis Regulations, sections 80 to 87.1 do not apply to a holder of a licence for analytical testing or a holder of a licence for research.

These general requirements are outlined in further detail below.

5.1.1 Standard operating procedures

As per section 80 of the Cannabis Regulations, cannabis and anything that will be used as an ingredient must be produced, packaged, labelled, distributed, stored, sampled and tested in accordance with standard operating procedures (SOPs). The SOPs must be designed to ensure that those activities are conducted in accordance with the requirements of Part 5 and Part 6.

The SOPs should include all steps necessary to be in compliance with GPP with a view to avoiding adverse impacts on the quality of the cannabis (e.g., such as cannabis or an ingredient becoming contaminated, or of extraneous substances being inadvertently added to the cannabis).

Examples of SOPs that may be developed in relation to key operational elements include:

• Sanitation of the building or part of a building and equipment
• Employee hygiene
• Distribution, including transfer, and receipt of cannabis and ingredients
• Production and processing of cannabis and ingredients include:
  • Cloning of cannabis plants or propagation of cannabis plant seeds
  • Trimming
  • Additions of nutrients, fertilizers and pest control products
  • Harvesting
  • Drying, curing or burping
  • Extraction processing
  • Encapsulation and other discrete unit production
  • Production of edible cannabis or an ingredient used to make edible cannabis
  • Production of a cannabis extract or cannabis topical, or an ingredient intended to be present in the final form of the cannabis extract or the cannabis topical
• Sampling and testing of cannabis
• Packaging and labelling (e.g., for bulk cannabis, samples, immediate container and discrete units)
• Storage (e.g., for bulk cannabis, ingredients, quarantined product, product on hold, product approved for sale, product in transit and product destined for destruction)

Examples of principles or practices that may demonstrate compliance with section 80 include:

• Licence holders have a system in place to review procedures on a regular basis and revise them as needed.
• If a licence holder needs to deviate from an SOP, details of the deviation (e.g., the reason for the deviation, whether it was planned and an assessment of GPP impacts) are documented in a report in accordance with an SOP.
• All personnel who conduct the activities described in a SOP are provided with training on the SOP.
• Training is provided and documented prior to the implementation of new or revised SOPs.

Licence holders should refer to section 5.2.1 of this guide for additional information regarding approval of the SOPs by the quality assurance person (QAP), where applicable, prior to SOPS being used at the site.

Licence holders may consider using the following elements to develop their SOPs:

• Purpose
  • A brief statement indicating the reason for the procedure
• Scope
  • Defines the area covered and any relevant exclusion
• Responsibility
  • Defines, as an overview, the functional unit(s) or individuals responsible for carrying out the procedure
• References
  • List, as appropriate, reference to the corresponding chapter in a quality manual, applicable quality system standard, regulation or other related procedure
• Terminology
  • Definitions to eliminate uncertainty over words or terms used in the procedure
• Procedures, instructions, methods, and actions
  • Describes the step-by-step actions that need to be taken
• Documentation
  • Includes the kinds of records associated with the procedure where they are filed, and the length of time the records are retained. Record retention time periods may alternatively be stated in general procedures for control of documentation and data and may simply be referred to in individual procedures.
• Revision sheet or table
  • Includes the revision level (letter, number or combination), the date of the revision, the effective date of the revision, and a brief description of the change(s). Tracking of revisions may alternatively be maintained as part of general documentation control procedures.
• Attachments
  • Includes forms to be used in carrying out the procedure. The procedure should refer to the specific attachment that includes the relevant form (e.g., "For this procedure a recall reporting form [Attachment X] is recommended.")

Other good documentation practices that licence holders may consider when developing their SOPs include:

• Involving the users in writing, reviewing, testing and modifying the procedures
• Printing the names of individuals who prepare and approve procedures
• Including signatures and the approval dates of those indicating their approval of the procedure
• Numbering sections, paragraphs and pages to facilitate reading and discussion
• Using text that is clear, simple and concise

5.1.2 Pest control products, sanitizers, agronomic inputs and non-food chemical agents

5.1.2.1 Pest control product

As per subsection 81(1) of the Cannabis Regulations, cannabis must not be treated with a pest control product unless the product is registered for use on cannabis under the Pest Control Products Act (PCPA), or is otherwise authorized for use under the PCPA. Edible cannabis, however, may be treated during the course of production with a pest control product that is exempt from the PCPA pursuant to subparagraph 3(1)(b)(ii) of the Pest Control Products Regulations (i.e., a food preservative), as per subsection 81(2) of the Cannabis Regulations.

5.1.2.2 Sanitizers, agronomic inputs and non-food chemical agents

As per section 81.1 of the Cannabis Regulations, any sanitizer, agronomic input or non-food chemical agent that is present at a site must be properly and clearly identified, must be suitable for its intended use and must not present a risk of contamination of the cannabis or anything that will be used as an ingredient. It also must be handled and used in a manner that does not present a risk of contamination of the cannabis or anything that will be used as an ingredient and that is in accordance with any manufacturer's instructions.

Examples of principles or practices that may demonstrate compliance with section 81.1 include the following:

• All sanitizers, agronomic inputs and non-food chemical agents that are present at the site are clearly identified (e.g., if labels or tags are used, they are clear and legible and if any sanitizer, agronomic input or non-food chemical agent is transferred to a different container, each subsequent container is identified).
• Oil that is used to lubricate equipment that comes into contact with cannabis or anything that will be used as an ingredient is food grade.
• Sanitizers and cleaners that are used on surfaces which will come into contact with cannabis or anything that will be used as an ingredient, are suitable for use on these contact surfaces and do not contaminate cannabis or anything that will be used as an ingredient.
• Non-food chemicals are used as appropriate for their application. For example, sanitizers are used to kill pathogens, and cleaning products are used to remove dirt and residues from cannabis, or anything that will be used as an ingredient, or used to remove other substances from surfaces which will come into contact with cannabis and anything that will be used as an ingredient.
• Agricultural chemicals that are used are approved for use on cannabis or anything that will be used as an ingredient, as applicable.
• Sanitizers, cleaners and disinfectants are used and handled in a manner that does not present a risk of contamination to cannabis or anything that will be used as an ingredient and are used according to the manufacturer's instructions (e.g., sanitizers, cleaners and disinfectants used on surfaces which come into contact with cannabis or anything that will be used as an ingredient, are used in a manner such that there is no contact, including residual contact with the cannabis or anything that will be used as an ingredient). Manufacturer's instructions on contact time, temperature and concentration for sanitizers and non-food chemical agents are followed.
• The manufacturer's instructions on the time interval and concentration for agricultural chemicals, including any pest control products are followed.

Examples of records pertaining to section 81.1 of the Cannabis Regulations that may be maintained by a licence holder to demonstrate their compliance with Part 5 are records indicating that the sanitizer, agronomic input or non-food chemical agents were handled and used in accordance with applicable SOPs and copies of usage instructions provided by the manufacturer or supplier.

5.1.3 Storage and distribution

5.1.3.1 Storage

As per section 82 of the Cannabis Regulations, cannabis and anything that will be used as an ingredient must be stored under conditions that maintain its quality.

Examples of principles or practices that may demonstrate compliance with section 82 include the following:

• Storage areas are designed and maintained to ensure good storage conditions. This includes orderly storage of cannabis and ingredients and prevention of cross-contamination of the various categories of materials and cannabis (e.g., in-process; bulk cannabis; cannabis in immediate containers and cannabis accessories; samples; material that is quarantined, approved for sale, rejected, returned or recalled; and material awaiting destruction). In particular, these areas are clean, dry and have adequate air circulation. To reduce human error, general storage areas are well lit and materials and cannabis are labelled accordingly.
• All cannabis and anything to be used as an ingredient, including samples, are stored according to the recommended storage conditions that will be set out on the cannabis product label. When specified on the label, controls for temperature, humidity and light are in place and monitored using calibrated monitoring devices.
• Records of temperature and humidity deviations are maintained, where applicable. Adherence to these conditions is verified periodically.

The following are examples of storage records that may be maintained by a licence holder to demonstrate their compliance with Part 5:

• Records of temperature, humidity and lighting generated from the storage locations.
• Records of temperature and humidity deviations.
• Records demonstrating adequate maintenance and calibration, if applicable, for the temperature, humidity and lighting monitoring devices.

5.1.3.2 Distribution

As per section 83 of the Cannabis Regulations, cannabis and anything that will be used as an ingredient must be distributed in a manner that maintains its quality.

Examples of principles or practices that may demonstrate compliance with section 83 include the following:

• Vehicles used in the distribution (e.g., transferring, transporting, sending, delivering, providing) of cannabis and anything to be used as an ingredient are equipped with the necessary means to maintain its quality. For example, the vehicle may require temperature and humidity monitoring as well as temperature control when it is being used to transport cannabis that is sensitive to temperature and humidity (e.g., cannabis plants). The vehicles are clean, dry and capable of maintaining air quality.
• Vehicles are inspected to verify that they do not impact the quality of cannabis or anything to be used as an ingredient.
• Cannabis and anything to be used as an ingredient is packaged and shipped in accordance with approved SOPs.

In addition, when distributing cannabis, a licence holder must take any steps that are necessary to ensure the safe-keeping of cannabis when distributing it, as per the requirement under section 47.

The following are examples of distribution records that may be maintained by a licence holder to demonstrate their compliance with Part 5 include:

• Records indicating that cannabis and anything that will be used as an ingredient was packaged and shipped in accordance with applicable SOPs.
• Records tracking all personnel handling the product during distribution.
• Records demonstrating adequate sanitation, maintenance, and environmental conditions of the carrier.

5.1.4 Building/part of a building

As per section 84 of the Cannabis Regulations, any building or part of a building where cannabis or anything that will be used as an ingredient is produced, packaged, labelled, stored, and tested must be designed, constructed and maintained in a manner that permits those activities to be conducted appropriately and under sanitary conditions.

In particular, the building or part of the building must be designed, constructed, and maintained in a manner that permits it to be kept clean and orderly, permits effective cleaning of all its surfaces, prevents the contamination of cannabis or anything that will be used as an ingredient and prevents the introduction of extraneous substances to the cannabis or anything that will be used as an ingredient.

Examples of principles or practices that may demonstrate compliance with section 84 include the following:

• Design and construction of the building or part of building (e.g., doors, windows, ceilings, floors, pipes, light fittings, ventilation points):
  • The building or part of the building is designed or constructed in a manner that facilitates maintenance, cleaning and sanitary operations, which includes the repeated application of cleaning and disinfecting agents.
  • Brick, cement block and other porous materials are sealed and surface materials that shed particles are not used. Joints between walls, ceilings and floors are sealed.
  • There are no holes or cracks in doors, windows, walls, ceilings and floors (other than those intended by design).
  • The building or part of the building prevents entry of insects and other animals or extraneous substances (or from one area to another), facilitates waste treatment and disposal, and prevents mix-ups and cross-contamination.
  • Floor plans and the building or part of the building design are laid out to allow production to take place in areas connected in a logical order, corresponding to the sequence of the operations and to the requisite cleanliness levels.
  • Doors that give direct access to the exterior from manufacturing and packaging areas are used for emergency purposes only and these doors are properly sealed.
  • Receiving and shipping areas do not allow direct access to production areas.
  • Mechanical areas such as boiler rooms, generators, and other engineering areas are segregated from production areas.
  • Screen and trap floor drains. Drains do not cause water to pool.
• Maintenance program
  • The building or part of the building is regularly monitored and carefully maintained.
  • Regular maintenance is performed to prevent deterioration of the building or part of the building.
  • Repair and maintenance operations do not present any hazard to the quality of the cannabis.

Examples of records pertaining to section 84 of the Cannabis Regulations that may be maintained by a licence holder to demonstrate their compliance with Part 5 are records of maintenance and service demonstrating the upkeep of the building or part of the building.

5.1.5 System - filtration and ventilation, supply of water, and lighting

5.1.5.1 System - filtration and ventilation

As per section 85 of the Cannabis Regulations, any building or part of a building where cannabis or anything that will be used as an ingredient is produced, packaged, labelled, stored or tested must be equipped with a system that must be able to:

• Filter air to prevent the escape of cannabis odours associated with cannabis plant material to the outdoors.
• Provide natural or mechanical ventilation with sufficient air exchange to provide clean air and to remove unclean air in order to prevent the contamination of the cannabis or thing that will be used as an ingredient, except in the case of any building or part of a building where the only activities being conducted in respect of cannabis and anything that will be used as an ingredient are its cultivation, propagation or harvesting.
• Be accessible and, if necessary for its cleaning, maintenance or inspection, be disassembled, except in the case of any building or part of a building where the only activities being conducted in respect of anything that will be used as an ingredient are its cultivation, propagation or harvesting;
• Withstand repeated cleaning, except in the case of any building or part of a building where the only activities being conducted in respect of anything that will be used as an ingredient are its cultivation, propagation or harvesting; and
• Function in accordance with its intended use, except in the case of any building or part of a building where the only activities being conducted in respect of anything that will be used as an ingredient are its cultivation, propagation or harvesting.

All conditions under which activities with cannabis or anything that is to be used as an ingredient are being conducted should maintain the quality of the cannabis or the ingredient.

Examples of principles or practices that may demonstrate compliance with section 85 include the following:

• System - filtration and ventilation
  • Any building or part of a building used for the production, packaging, labelling, storage, or testing of cannabis is equipped with an adequate system that is capable of maintaining air quality within it.
  • Is designed in a manner in which the air exchange is sufficient for maintaining the air quality of the building or any area of the building with the exception of any building or part of a building where the only activities being conducted are the cultivation, propagation and harvesting of cannabis or anything that will be used as an ingredient.
  • Prevents the accumulation of heat, steam, condensation or dust.
  • Is equipped with close-fitting screens or filters to prevent the entry of dust, smoke, steam, odours, and contaminated air.
• Maintenance program
  • Ventilation and air filtration should be maintained in accordance with a schedule.
  • Maintenance operations are carried out in a manner that do not present any risk to the quality of the cannabis or anything that will be used as an ingredient.
  • The presence of odours surrounding the building or part of a building are monitored in accordance to a schedule and responded to if necessary.
  • Inspection and repair activities occur when required.

The following are examples of records pertaining to section 85 of the Cannabis Regulations that may be maintained by a licence holder to demonstrate their compliance with Part 5:

• Records of installation
• Maintenance and service of the ventilation and filtration systems
• Replacements of filters

5.1.5.2 Supply of water

As per section 85.1 of the Cannabis Regulations, any system that supplies water to a site must be appropriate for the activities being conducted with cannabis and anything that will be used as an ingredient. In addition, any system that supplies potable water to a site must not be cross-connected with any other system, unless measures are taken to eliminate any risk of contamination of the cannabis or anything that will be used as an ingredient, resulting from the cross-connection.

Examples of principles or practices that may demonstrate compliance with section 85.1 include:

• Water supply
  • The water supply is appropriate for the intended use and is of a quantity and pressure sufficient for the operational needs of the site.
  • Measures to eliminate the risk of contamination of the cannabis or anything that will be used as an ingredient are in place, such as filtration or UV lights.
  • If water is reclaimed or reused, the water is treated and maintained in a manner that will not increase the risk of contamination of cannabis or anything that will be used as an ingredient.
  • Monitoring, including chemical and microbiological testing, is conducted on a periodic basis.
• Cross-connections:
  • Cross-connections only exist between potable water systems that are protected against contamination, or water systems that do not present a risk of contamination of cannabis or anything that will be used as an ingredient.
  • Hoses, taps and other similar sources of possible contamination are designed to prevent back-flow or back-siphonage and have prevention devices installed as applicable.
  • Visual inspection of non-mechanical (air gaps) and mechanical prevention devices and testing of back-flow preventers are conducted on a periodic frequency.

Examples of records pertaining to section 85(1) of the Cannabis Regulations that may be maintained by a licence holder to demonstrate their compliance with Part 5 are records of testing for source water, maintenance, service and sanitation records of water systems, including visual inspections.

5.1.5.3 Lighting

As per section 85.2 of the Cannabis Regulations, any building or part of the building where cannabis or anything that will be used as an ingredient is produced, packaged, labelled, stored or tested must be equipped with natural or artificial lighting that is appropriate for the activity being conducted.

Furthermore, any lighting fixtures in the building or part of the building where these activities are being conducted must be capable of withstanding repeated cleaning and, if necessary to prevent the contamination of the cannabis or thing that will be used as an ingredient, repeated sanitizing. The lighting fixture must not present a risk of contamination of the cannabis or thing that will be used as an ingredient in the event of a breakage.

Examples of principles or practices that may demonstrate compliance with section 85.2 include the following:

• Natural or artificial lighting:
  • The lighting used within the building or part of a building is appropriate in terms of placement and intensity for the cannabis or thing that will be used as an ingredient and the activity being conducted (e.g., areas where cannabis, ingredients or packaging materials are inspected, may require a higher intensity of light than storage areas).
  • The lighting used does not alter the natural colour, affect the quality, result in the production of natural toxins and microorganisms of cannabis or anything that will be used as an ingredient, or cause them to deteriorate.
  • The effectiveness of chemical sanitizers is unaffected, as applicable (e.g., certain chemical sanitizers deteriorate during storage and exposure to light, such as chlorine dioxide and sodium hypochlorite).
• Light fixtures are:
  • Constructed from shatter-resistant materials.
  • Shielded with safety covers when they have materials like glass that could break, so as to contain broken materials.
  • Constructed from material that can be repeatedly cleaned and, if necessary, sanitized.
  • Installed in a manner that permits for routine cleaning.
  • Cleaned, sanitized, and maintained in accordance with approved SOPs.

Examples of records pertaining to subsection 85(2) of the Cannabis Regulations that may be maintained by a licence holder to demonstrate their compliance with Part 5 are records cleaning, sanitization and maintenance of light fixtures, and supplier specification sheets indicating ingredient storage requirements.

5.1.6 Equipment

As per section 86 of the Cannabis Regulations, cannabis and anything that will be used as an ingredient must be produced, packaged, labelled, stored, sampled and tested using equipment that is designed, constructed, maintained, operated and arranged in a manner that:

• Permits the effective cleaning of its surfaces;
• Permits it to function in accordance with its intended use;
• Is accessible and, if necessary for its cleaning, maintenance or inspection, is able to be disassembled;
• Prevents the contamination of the cannabis and anything that will be used as an ingredient;
• Except in the case of outdoor cultivation, propagation or harvesting, prevents the addition of an extraneous substance to the cannabis and anything that will be used as an ingredient; and
• Except in the case of outdoor cultivation, propagation or harvesting, protects the cannabis or anything that will be used as an ingredient against allergen cross-contamination.

In addition, cannabis and anything that will be used as an ingredient must be distributed using a conveyance that is designed, constructed, maintained and operated in a manner that prevents the contamination of the cannabis or anything that will be used as an ingredient. A conveyance includes anything within the licenced site to transport cannabis or ingredients within the site.

Examples of principles or practices that may demonstrate compliance with section 86 include the following:

• Use and function of equipment
  • Equipment is verified to be functioning as intended by the manufacturer before use.
  • Equipment that is used for more than one class of cannabis or ingredient is appropriate for each substance.
• Design, construction and operation of equipment, including utensils, such as pruning shears, pots, trays, extractors, beakers, and conveyances (e.g., a forklift or a hand lift), and the arrangement of equipment
  • Where necessary, proper drainage is permitted from the equipment and, where applicable, is connected directly to drains.
  • Where necessary, equipment exhausts to the outside of the building or conveyance to prevent excessive condensation.
  • Equipment and conveyances have no internal horizontal ledges that have hidden or hard-to-clean areas.
  • Equipment and conveyances have protective shields, lids or covers to prevent contamination.
  • Equipment and conveyances do not contaminate cannabis or anything that will be used as an ingredient in the event of a failure of any parts.
  • Any equipment or conveyance determined to be defective is removed or clearly labelled as defective when removal is not feasible.
  • Balances and measuring equipment of an appropriate range, precision and accuracy are used.
  • Equipment is installed with sufficient space around it to permit its proper operation, maintenance, and cleaning.
  • Repairs are permanent and durable in nature. Temporary repairs (e.g., with tape) are avoided.
  • Repair and maintenance operations are performed in a manner that does not present a risk to the quality of the cannabis or anything that will be used as an ingredient, taking into consideration the location of the repairs relative to the cannabis or anything that will be used as an ingredient, and are performed at a prescribed frequency or as necessary to ensure that the equipment or conveyance continues to function as intended to reduce the risk of contamination.
• Accessibility for cleaning and sanitizing, maintenance and inspection of equipment:
  • Contact surfaces of equipment that comes into contact with cannabis and anything that will be used as an ingredient are accessible.
  • Equipment is installed and arranged in a manner such that it can be reached and there is sufficient room to clean them.
  • Equipment can be disassembled for cleaning and sanitizing.
  • Equipment is stored in clean and dry conditions that optimize the flow of material while minimizing the movement of personnel. Clean or sanitized equipment is stored in an area separate from used or dirty equipment and conveyances and in a manner that prevents re-contamination.
• Maintenance program
  • Written maintenance and calibration programs are implemented and include a list of equipment with its locations requiring regular maintenance and calibration (e.g., balances and pH meters). Instructions are included on how to perform such activities, the frequency of such activities, measures to be taken if equipment does not function as intended, identification of the individuals who are assigned responsibility for the maintenance and calibration procedures and names of external companies conducting such activities, if applicable.

Examples of records pertaining to section 86 of the Cannabis Regulations that may be maintained by a licence holder to demonstrate their compliance with Part 5 are records of maintenance and servicing of equipment (e.g., cleaning, repair and calibration) used during all steps of production, packaging, labelling, storage, sampling and testing.

5.1.7 Sanitation

5.1.7.1 Sanitation program

As per section 87 of the Cannabis Regulations, cannabis and anything that will be used as an ingredient must be produced, packaged, labelled, distributed, stored, sampled and tested in accordance with a sanitation program. The sanitation program must set out:

• Procedures for effectively cleaning the building or part of the building where those activities with cannabis or anything that will be used as an ingredient are conducted (this does not apply to outdoor cultivation, propagation or harvesting of cannabis or anything that will be used as an ingredient);
• Procedures for effectively cleaning the equipment and conveyances used in those activities with cannabis;
• Procedures for handling any substance used in those activities; and
• Any health and hygiene requirements for personnel necessary to ensure sanitary conditions.

Examples of principles or practices that may demonstrate compliance with section 87 include the following:

• The building (where applicable) and equipment are cleanable and capable of withstanding repeated sanitizing or disinfecting (e.g., they are smooth, non-reactive, corrosion-resistant, non-toxic) as per approved SOPs.
• The sanitation program specifies the locations and/or equipment to be cleaned, the cleaning agents to be used, the mixing instructions, the temperature controls, the person(s) responsible, the frequency of each activity and the detailed procedures for cleaning and/or sanitizing.
• The effectiveness of the sanitation program is monitored and verified. Where applicable, the QAP is responsible for overseeing the implementation and effectiveness of the sanitation program. Any changes that may affect the cleaning process are assessed and documented.
• Approved SOP(s) listing the basic health and hygiene requirements are made available to all personnel involved in cleaning the building or part of the building and equipment or in handling substances used in those activities with cannabis.
• Effective control programs are in place to prevent the entry of animals, such as insects, rodents, birds or other vermin to any part of the building, to detect and eliminate animals, and to prevent the contamination of cannabis.

A licence holder that is subject to Part 5 must maintain records describing the sanitation program referred to in section 87 of the Cannabis Regulations that is in use at the site described in the licence. Such records may include the following:

• Building and equipment cleaning records
• Equipment maintenance records
• Employee training records
• Cleaning solution usage and preparation records

5.1.7.2 Hand cleaning and hand sanitizing stations and lavatories

As per subsection 87.1 of the Cannabis Regulations, if necessary to prevent contamination of cannabis or anything that will be used as an ingredient, a site must be equipped with hand cleaning and hand sanitizing stations and lavatories.

The hand cleaning and sanitizing stations and lavatories must be:

• Appropriately equipped and adequate in number and size for the number of individuals using them;
• Located so that they are readily accessible to the individuals using them; and
• Capable of withstanding repeated cleaning and, if necessary to prevent contamination of the cannabis or anything that will be used as an ingredient, repeated sanitizing.

In addition, the hand cleaning and hand sanitizing stations must permit the effective cleaning and sanitation of hands and lavatories must be located and maintained so that they do not present any risk of contamination of cannabis or anything that will be used as an ingredient.

Examples of principles or practices that may demonstrate compliance with section 87.1 include:

• Hand cleaning, hand sanitizing stations and lavatories are:
  • Constructed in such a way that avoids splashing of water into cannabis or anything that will be used as an ingredient or any contact surfaces
  • Accessible for the use by employees at all times
  • Are durable, cleanable and maintained in a clean and sanitary condition
• In addition, hand cleaning and hand sanitizing stations:
  • Are located at entrances to production areas, in close proximity to the lavatories, and anywhere else deemed necessary (e.g., if outdoor production is taking place, in addition to lavatories, hand cleaning and hand sanitizing stations are accessible)
  • Not used for other purposes
  • Equipped to provide hot and cold, or premixed warm, running water, and cleaning or sanitizing agents, and are equipped with supplies or equipment that can dry hands in a sanitary manner
  • Equipped with a sign that explains proper hand washing procedures

Examples of records pertaining to section 87.1 of the Cannabis Regulations that may be maintained by a licence holder to demonstrate their compliance with Part 5 are records of cleaning or maintenance of hand cleaning and hand sanitizing stations and lavatories.

5.2 Additional requirements - Holder of a licence for processing

5.2.1 Quality assurance

As per section 88 of the Cannabis Regulations, a holder of a licence for processing must ensure the following:

• All quality-related complaint investigations and risk mitigation measures and all cannabis or ingredient risk investigations and mitigation measures are conducted under the responsibility of the QAP referred to in section 19 of the Cannabis Regulations;
• If necessary, following an investigation, the QAP immediately cause measures to be taken to mitigate any risk;
• Cannabis or 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 QAP;
• In the case of a cannabis extract or edible cannabis, the QAP approves the preventive control plan prior to its implementation; and
• Every lot or batch of cannabis is approved by the QAP before it is made available for sale.

A licence holder may have employees in addition to the QAP (or alternate QAP) who carry out activities related to the quality assurance requirements under section 88 of the Cannabis Regulations. The QAP may assign quality assurance duties to a person who has the relevant knowledge, training and experience that are applicable to the class of cannabis in respect of the activities being conducted; however, the QAP remains responsible for the quality of the cannabis produced and for investigating complaints as per section 19 of the Cannabis Regulations. If, however, the QAP does not have the training, experience and technical knowledge related to the requirements of Parts 5 and 6 that are applicable to edible cannabis, and the licence holder conducts activities for this class of cannabis, the licence holder must retain the services of another individual who has the training experience and technical knowledge.

The QAP should be able to demonstrate that each individual who has been assigned quality assurance duties has the training, experience and technical knowledge related to the licensed activities, as well as appropriate knowledge of the requirements of Part 5 and Part 6 in relation to the duties and responsibility assigned to them. This may include letters of reference; a copy of a diploma or certificate; and any other documentation supporting their qualifications, training and experience.

To demonstrate that the QAP maintains accountability and overall responsibility of the requirements, the QAP may:

• Follow a written program to assess and train these individuals;
• List in a written work description specific duties for all staff who have been assigned quality assurance activities;
• Ensure that the assignment of duties to any one individual is such that quality is not put at risk or compromised; and
• Periodically assess that licensed activities are conducted in accordance with the requirements of Part 5, including a review of the performance of individuals who have been assigned quality assurance duties. This may include random verification of various quality processes, such as approval of lots or batches of cannabis, ensuring SOPs reflect actual practices, or reviewing documents and interviewing staff to ensure duties are being conducted appropriately.

Investigations are conducted under the responsibility of the QAP:

• All investigations, including those addressing quality complaints and those concerning a potential risk to public health, or those regarding a potential lack of compliance with the requirements of Parts 5 and 6 of the Cannabis Regulations must be conducted according to approved procedures established by the licence holder.
• Complaints and other information concerning a potential risk to public health, or that regarding a potential lack of compliance with the requirements of Parts 5 and 6 of the Cannabis Regulations should be recorded with all the original details and thoroughly investigated. The investigation must be evaluated, and if necessary, measures must be taken immediately to mitigate any risk (e.g., putting the lot or batch on hold until the investigation is completed).
• Complaint records should be routinely verified to ensure that all adverse reactions (including serious adverse reactions) are documented and reported in accordance with section 248 of the Cannabis Regulations.
• Licence holders may choose to keep additional samples of a lot or batch for their own purposes in order to investigate quality-related complaints and determine on whether a recall may be required.

Methods, procedures and plans:

• Cannabis or anything that will be used as an ingredient must be produced, packaged, labelled, distributed, stored, sampled and tested using methods and procedures that, prior to their implementation, have been approved by the QAP.
• If circumstances require a deviation from an approved SOP, the QAP must ensure that the deviation is assessed and document that all GPP requirements are still being met.
• The QAP must ensure that the preventive control plan is approved prior to implementation. The QAP is responsible for ensuring that procedures are put into place to implement the plan.

Licence holders should refer to section 5.1.1 of this guide for additional information regarding SOPs.

Approval prior to sale:

• The QAP must ensure that the results of the required tests in sections 90 to 91.1 of the Cannabis Regulations and pesticide testing results are reviewed and assessed to confirm that the results are within the identified specification(s). Additionally, the QAP must ensure that the documentation for each lot or batch is reviewed and verified, and that the documentation demonstrates that the lot or batch has been produced in accordance with the approved SOPs. Only when there is confidence that the lot or batch was produced, packaged, labelled, distributed, stored, sampled and, where applicable, tested in accordance with Part 5 and Part 6, should the lots or batches be approved for sale.

5.2.2 Competencies and Qualifications

As per section 88.1 of the Cannabis Regulations, a licence holder must ensure that any individual that conducts activities in relation to edible cannabis or anything that will be used as an ingredient in the production of edible cannabis has the competencies and qualifications that are necessary to conduct those activities at the site set out in the licence.

Licence holders should be able to demonstrate that each individual who has been assigned duties has the appropriate competencies and qualifications related to the activities, as well as appropriate knowledge of the requirements of Part 5 and Part 6, in relation to the duties and responsibilities assigned to them. This may include letters of reference, a copy of a diploma or certificate and any other documentation supporting their qualifications, training and experience.

Examples of principles or practices that may demonstrate compliance with section 88.1 include the following:

• A written program is in place to assess and train individuals.
• Personnel who conduct the activities described in an SOP are provided with training on the SOP, and completion of the training is documented.
• Duties for all staff who have been assigned activities are specified in a written work description.
• There is a periodic assessment to ensure that activities related to edible cannabis or anything that will be used as an ingredient in edible cannabis are conducted in accordance with the requirements of Part 5 and Part 6. This may include a review of the performance of individuals who have been assigned duties; random verification of various quality processes, such as approval of lots or batches of cannabis; ensuring that SOPs reflect actual practices; or reviewing documents and interviewing staff to ensure duties are being conducted appropriately.

Examples of records pertaining to section 88.1 of the Cannabis Regulations that may be maintained by a licence holder to demonstrate their compliance with Part 5 include:

• Records of the training program
• Records of qualifications
• Records of verification checks, as applicable

5.2.3 Temperature and humidity, heating, cooling or humidity-control system

As per section 88.2 of the Cannabis Regulations, licence holders must ensure that the temperature and humidity of any building or part of a building where cannabis or anything that will be used as an ingredient is produced, packaged, labelled, stored or tested are maintained at levels that are appropriate for the activity being conducted with the cannabis or thing that will be used as an ingredient.

In addition, if the building or part of the building is equipped with a heating, cooling or humidity-control system, licence holders must ensure that the system has the following qualities:

• If necessary to prevent contamination of the cannabis or anything that will be used as an ingredient, it is equipped with instruments to control and indicate the temperature and humidity levels;
• Is accessible and, if necessary for its cleaning, main-tenance or inspection, is able to be disassembled;
• Is capable of withstanding repeated cleaning; and
• Functions in accordance with its intended use.

Examples of principles or practices that may demonstrate compliance with section 88.2 include the following:

• Appropriate temperature and humidity of any building or part of building:
  • Production areas are maintained at a temperature that prevents the growth of bacteria.
  • Cannabis and anything that will be used as an ingredient that requires refrigeration are stored at 4°C or less.
  • Cannabis and anything that will be used as an ingredient that requires freezing are stored at -18°C or less.
  • Humidity levels are maintained at a level that is low enough to prevent condensation, where condensation poses a risk to the safety of cannabis or anything that will be used as an ingredient.
  • Temperature and humidity are checked periodically to ensure that they are maintained at a level that is appropriate to the cannabis, the thing that will be used as an ingredient, and the activity being conducted.
  • Cannabis, and anything that will be used as an ingredient, is placed in refrigerated or freezer storage in a manner that does not restrict air flow, preventing them from reaching the required temperature.
• Heating, cooling and humidity-control system
  • A recording device, such as a thermometer, is used in the refrigerated and freezer storage area(s) that can monitor, record and control the temperature.
  • System ducts are equipped with cleanout doors to permit access for cleaning.
  • The system is made of material that is compatible with the chemicals and methods used for cleaning.
  • The capacity and design of the system is adequate for the conditions of the building.
  • The system's sensing device accurately measures the conditions in the building or part of a building. The device also activates and de-activates the system to maintain the temperature and humidity at pre-determined the levels.

Examples of records pertaining to section 88.2 of the Cannabis Regulations that may be maintained by a licence holder to demonstrate their compliance with Part 5 include:

• Temperature and humidity records generated from production, packaging, labelling, storage or testing of cannabis or anything that will be used as an ingredient
• Records of temperature and humidity deviations
• Records demonstrating adequate cleaning, maintenance and calibration, if applicable, for the temperature and humidity monitoring devices

5.2.4 Incompatible activities

As per subsection 88.3(1) of the Cannabis Regulations, a licence holder must ensure that physical or other effective means are used to separate incompatible activities in order to prevent contamination of the cannabis or anything that will be used as an ingredient.

A licence holder must ensure that, if two or more activities were to occur simultaneously, sequentially, or in close proximity, they would not present a risk of contamination of the cannabis or anything that will be used as an ingredient. Physical or other effective means refers to a separation by time, space or preparation practices.

Examples of principles or practices that may demonstrate compliance with subsection 88.3(1) include:

• Cleaning and sanitizing activities are not conducted in the same area(s) where production, packaging and labelling of cannabis or anything that will be used as an ingredient is taking place, (e.g., cleaning and sanitizing of production equipment or conveyances are carried out in a dedicated room for cleaning and sanitization, or if cleaning must be carried out in the same area, it is not done while production, packaging or labelling activities are taking place.)
• Cleaning is done in-between the production of different lots or batches of cannabis or anything that will be used as an ingredient.
• Dedicated equipment that is identifiable, via colour coding, or by other means is used.
• Shipping of cannabis product is separated from receipt of incoming cannabis or ingredients either by having two separate areas, or by separating the activities to ensure they do not occur at the same time and as per approved SOP(s).
• Storage of contaminated materials and waste is separate from the production, packaging, labeling, storage (non-contaminated materials, such as cannabis products or ingredients) and testing of cannabis and ingredients.
• Any in-house testing, such as, microbiological and pathogen testing, is conducted in a separate area from production packaging, labelling and storage areas.
• SOPs and processes regarding handling of cannabis and ingredients with allergens are in place to prevent cross contamination of cannabis or ingredients without allergens.
• Positive air pressure directs air flow from highly sensitive areas, such as aseptic rooms, to less sensitive areas, such as raw ingredient handling rooms.
• As applicable, in the case of outdoor cultivation, propagation or harvesting of cannabis or anything that will be used as an ingredient, or materials, such as agronomic inputs, are stored separately from water sources, cannabis and ingredients.

The Cannabis Regulations explicitly prohibit one type of incompatible activity: the co-location of cannabis production and conventional food production. Specifically, subsection 88.3(2) of the Cannabis Regulations states that, a licence holder must not produce, package, label or store cannabis at a site set out in the licence if food that the licence holder intends to sell is also produced, packaged or labelled at that site.

However, if a licence holder chooses to process cannabis and food products on the same site, then the production, packaging, labelling, and storage of cannabis and the production, packaging, and labelling of food products must be conducted in a separate building within the site as per subsection 88.3(3)of the Cannabis Regulations.

Examples of principles or practices that may demonstrate compliance with subsection 88.3(2) in relation to the co-location of cannabis production and conventional food production include:

• Ingredients which may be used in the production of cannabis and food that is intended for sale, may be stored in an area of a building or part of a building that is part of the site together, as long as the necessary measures are taken to ensure that the ingredient will not be contaminated.
• If the site set out on the licence is a unit within a larger building or complex, measures should be taken to ensure that there is no contamination of cannabis and ingredients if there are shared systems, such as heating, ventilation and air conditioning, or water systems.
• For licence holders who manufacture other non-cannabis products such as cosmetics, methods and procedures are implemented to prevent the contamination of cannabis or ingredients.

Examples of records pertaining to section 88.3 of the Cannabis Regulations that may be maintained by a licence holder to demonstrate their compliance with Part 5 include standard operating procedures preventing incompatible activities from occurring and site floor plans showing personnel and material flow.

5.2.5 Separation of cannabis and ingredients from contaminants

As per section 88.4 of the Cannabis Regulations, a holder of a licence for processing must ensure that physical or other effective means are used to separate can-nabis or anything that will be used as an ingredient from anything that presents a risk of contamination of the cannabis or thing that will be used as an ingredient.

Examples of principles or practices that may demonstrate compliance with section 88.4 include:

• The presence of SOP(s) and practices which demonstrate that cannabis or anything that will be used as an ingredient is separated from:
  • Other cannabis or anything that will be used as an ingredient which contains allergens
  • Sanitizers, agronomic inputs and other non-food chemical agents
  • Contaminated material and waste, including cannabis intended for destruction.

Examples of records pertaining to section 88.4 of the Cannabis Regulations that may be maintained by a licence holder to demonstrate their compliance with Part 5 include standard operating procedures and site floor plans showing personnel and material flow.

5.2.6 Ingredient-related risk of injury to human health

As per section 88.5 of the Cannabis Regulations, a holder of a licence for processing must ensure that anything that will be, or was intended to be, used as an ingredient that presents a risk of injury to human health is identified as such and placed in a desig-nated area within the site.

This may include, but is not limited to, anything that will be, or was intended to be used as an ingredient which has been subject to a recall, requires further processing due to hazards, or which may be undergoing an investigation as the ingredient poses a risk to injury to human health. Such circumstances may include storage conditions not being met, or SOPs not being followed during the production of the ingredient.

The licence holder should have a designated area assigned for any ingredient undergoing investigation and a manner in which to identify the ingredient (e.g., via signage and through inventory controls) to ensure that the ingredient is not used until such time as a decision on its disposition can be made. In addition, ingredients or chemicals which may be used during production which may present a risk of injury to human health, are stored in designated area(s) and appropriately identified (e.g., chemicals used during production of cannabis extracts, or allergens, such as nuts being separated at a building or part of a building where nut-free cannabis products are produced).

Control measures may be taken to prevent the contamination of other cannabis or anything that will be used as an ingredient at the site as necessary.

Examples of records pertaining to section 88.5 of the Cannabis Regulations that may be maintained by a licence holder to demonstrate their compliance with Part 5 include: Records of deviations and investigations including any risk mitigation measures taken and inventory records.

5.2.7 Potable water

As per section 88.6 of the Cannabis Regulations, a licence holder for processing must ensure that any water that might come into contact with a can-nabis extract, cannabis topical, edible cannabis or any-thing that will be used as an ingredient is potable; and if the water is not potable, the licence holder must ensure that it does not present a risk of contamination of the cannabis extract, cannabis topical, edible cannabis or anything that will be used as an ingredient.

In addition, a holder of a licence for processing must ensure that any steam or ice that might come into contact with a cannabis extract, a cannabis topical, edible cannabis or anything that will be used as an ingredient is made from water that meets the requirements of subsection 88.6(1) of the Cannabis Regulations. If the steam or ice does not meet those requirements, the licence holder must ensure that it does not present a risk of contamination of the cannabis extract, cannabis topical, edible cannabis or thing that will be used as an ingredient.

Examples of principles or practices that may demonstrate compliance with section 88.6 include the following:

• Municipal water sources are used for any water that will come in contact with a cannabis extract, cannabis topical, edible cannabis or anything that will be used as an ingredient.
• If a water source other than municipal water is used, water samples are tested in order to determine that the water is potable; licence holders should consider using an accredited laboratory or similarly rigorous process.
• Recirculated or reclaimed water, is treated, monitored, and maintained to prevent contamination of a cannabis extract, cannabis topical, edible cannabis or anything that will be used as an ingredient, in accordance with SOPs.
• The water distribution system in the establishment is enclosed and protected from contaminants. If a well is used, this includes covering the well head and ensuring it is protected appropriately.
• Ice machine doors are kept closed when not in use and ice is stored in the machine.

For information on potable water standards, refer to Guidelines for Canadians Drinking Water Quality - Summary Table. Licence holders may also consult From Source to Tap: Guidance on the Multi-Barrier Approach to Safe Drinking Water that provides operators of a water supply with a risk-based management plan for producing potable water.

Examples of records pertaining to section 88.6 of the Cannabis Regulations that may be maintained by a licence holder to demonstrate their compliance with Part 5 include:

• Results from testing of the water source, including third-party labs, in-house testing or municipal reports.
• Maintenance and sanitation records pertaining to the system that supplies water as applicable.

5.2.8 No presence of animals

As per section 88.7 of the Cannabis Regulations, a holder of a licence for processing must ensure that no animal is present in any building or part of a building, where cannabis or anything that will be used as an ingredient is produced, packaged, labelled or stored.

Examples of principles or practices that may demonstrate compliance with section 88.7 include the following:

• Roof, air intakes, foundation, walls, floors, drains, doors and windows in any building or part of a building prevent the entry of animals, such as insects, rodents, birds or other vermin.
• Control measures and procedures (SOPs) are in place to discourage pests from harbouring in any building or part of building and in the surrounding area where production, packaging, labelling or storage is taking place, and measures are taken to detect pests in the building or part of a building, and to immediately eliminate pests when they are identified.
• Measures taken to comply with section 88.7 do not pose a risk of contamination to cannabis or anything that will be used as an ingredient which will be produced, packaged, labelled or stored (e.g., pest control products and devices are used in a manner that does not cause contamination, pest control devices are periodically checked in accordance with a schedule and emptied as necessary). Animals, such as cats, are not used as a means of pest control in the building or any part of the building. This does not prohibit a licence holder who also possesses a licence for cultivation from using beneficial insects in the grow areas.

Examples of records pertaining to section 88.7 of the Cannabis Regulations that may be maintained by a licence holder to demonstrate their compliance with Part 5 include records of building maintenance, including verification checks and third-party and internal pest control records, such as pest control product application records, as applicable.

5.2.9 Land-related risk of contamination

As per section 88.8 of the Cannabis Regulations, if any land that forms part of a site set out on a licence for processing, or any land that is located near such a site, presents a risk of contamination of cannabis or anything that will be used as an ingredient, the licence holder must take measures to eliminate the risk.

Examples of principles or practices that may demonstrate compliance with section 88.8 include the following:

• The land and surrounding area around any building or site is maintained to prevent animals, including pests, from harbouring around any building, by removing any debris and refuse, keeping grass trimmed and removing dead vegetation.
• Waste containers are cleaned regularly.
• Grading of the site surrounding any building is done to allow water to drain water away from the building(s).
• If the site is located near a source of contamination, such as sanitary landfills, oil refineries, chemical plants, paper and steel mills, any building air intakes are located away from those sources and the incoming air passes through filters to remove any contaminants.
• If propagation, cultivation and harvesting of anything that will be used as an ingredient takes place outdoors:
  • Sources of contamination are identified and the field is not used, or the ingredients are not harvested and brought into any building, until it is certain that the ingredient will not contaminate cannabis or anything else that will be used as an ingredient.
  • Adjoining land is assessed for potential sources of contamination that may drift to the site. Where sources of contamination are identified, measures are taken to mitigate or eliminate the risk of contamination.

Examples of records pertaining to section 88.8 of the Cannabis Regulations that may be maintained by a licence holder to demonstrate their compliance with Part 5 include building maintenance and verification check records.

5.2.10 Removal and disposal of contaminated materials and waste

As per subsection 88.9(1) of the Cannabis Regulations, a holder of a licence for processing must ensure that any building or part of a building where cannabis or anything that will be used as an ingredient is produced, packaged, labelled or stored has available the means for the removal and disposal of contaminated materials and waste and, if necessary to prevent contamination of the cannabis or anything that will be used as an ingredient, that the building or part of the building is equipped with a drainage, sewage and plumbing system that functions in accordance with its intended use.

In addition, the licence holder must ensure that contamin-ated materials and waste are removed and disposed of at a frequency that is sufficient to prevent contamination of the cannabis or anything that will be used as an ingredient and in a manner that does not present a risk of contamina-tion of the cannabis or anything that will be used as an ingredient.

Examples of principles or practices that may demonstrate compliance with subsection 88.9(1) include:

• Drainage and sewage systems are in place that can accommodate the volume and type of effluent produced at the site, and are equipped with traps and vents to prevent backflow.
• Waste and contaminated materials are removed at a set frequency, or more often if necessary, so they do not overflow.
• Removal of contaminated materials and waste is done using predetermined routes (e.g., effluent or sewage lines are constructed so they do not pass directly over or through production areas, unless measures are taken to prevent risk of contamination of cannabis or anything that will be used as an ingredient, and the employees who remove the contaminated material and waste wear appropriate clothing, such as overalls, gloves and boots, when removing the contaminated materials and waste).

Examples of records pertaining to section 88.9 of the Cannabis Regulations that may be maintained by a licence holder to demonstrate their compliance with Part 5 include building engineering drawings, sanitation records, destruction records and third-party waste removal contracts and records, as applicable.

5.2.11 Conveyances and equipment

As per section 88.91 of the Cannabis Regulations, a licence holder for processing must ensure that any conveyance or equipment used at the site set out in the licence to handle any contaminated materials or any waste, be used only for that purpose, be identified as being reserved for that purpose, and meet the applicable requirements of section 86 of the Cannabis Regulations, unless that conveyance or equipment does not come into contact with those materials or waste.

Examples of principles or practices that may demonstrate compliance with section 88.91 for conveyances and equipment used for handling contaminated materials or waste include:

• Conveyances and equipment are identified for the specific purpose of handling contaminated materials or waste by the use of labelling or colour coding, and are segregated from conveyances and equipment not intended for that purpose, to prevent the contamination of cannabis or anything that will be used as an ingredient.
• Employees are aware of the system used to identify equipment reserved for handling contaminated materials, waste, or other inedible things, via training or through the use of SOPs, as applicable.

Examples of records pertaining to section 88.91 of the Cannabis Regulations that may be maintained by a licence holder to demonstrate their compliance with Part 5 include:

• SOPs and training records demonstrating that procedures are in place for handling contaminated materials or waste.

5.2.12 Clothing, footwear and protective coverings

As per section 88.92 of the Cannabis Regulations, a holder of a licence for processing must ensure that any individual who enters or is in a build-ing or part of a building where cannabis or anything that will be used as an ingredient is produced, packaged, labelled, stored, sampled or tested wears clothing, footwear and protective coverings that are appro-priate for the activity being conducted with the cannabis or anything that will be used as an ingredient. This includes gloves, a hairnet, a beard net, and a smock that are in a good, clean and sanitary condition.

Examples of principles or practices that may demonstrate compliance with section 88.92 include:

• To prevent contamination, a procedure is in place to ensure that appropriate clothing, footwear and protective coverings are worn by employees, visitors and contractors when entering and moving in the building or part of building where activities with cannabis or anything that will be used as an ingredient is taking place.
• Clothing, footwear and protective coverings are stored in designated, accessible locations and in a manner which prevents contamination (e.g., items required for production activities are stored in cabinets adjacent to production area).
• Measures are taken to ensure that clothing, footwear and protective coverings are in good condition (e.g., as required depending on the activity being conducted, clothing, footwear and protective coverings are removed during breaks and changed or cleaned as necessary throughout the course of a shift; and re-used items are made of materials that can be cleaned and sanitized and are regularly washed. Items intended for one-time use should not be re-used).

Examples of records pertaining to section 88.5 of the Cannabis Regulations that may be maintained by a licence holder to demonstrate their compliance with Part 5 include an SOP listing the health and hygiene requirements for the facility and training records.

5.2.13 Identification and analysis of hazards - Prevention, elimination and reduction of hazards

As per section 88.93 of the Cannabis Regulations, a holder of a licence for processing that produces a cannabis extract or edible cannabis must identify and analyze the biological, chemical and physical hazards that present a risk of contamination of the cannabis or anything that will be used as an ingredient in the produc-tion of the cannabis extract or edible cannabis.

For each cannabis extract and edible cannabis, identify and describe any biological, chemical and physical hazards that may be reasonably expected to contaminate the cannabis extract and edible cannabis through:

• the inputs (e.g., ingredients and packaging materials),
• processing steps, and
• traffic flows

In addition, the licence holder must prevent, eliminate or reduce to an acceptable level these hazards by using control measures that are shown by evidence to be effective, including any treatment or process. Evidence of effectiveness should be kept up to date and take into consideration changes in formulations, new processing equipment, and emerging new information or processing data.

It is good practice to review and update the hazard analysis periodically to ensure any new hazards are identified and evaluated.

5.2.14 Preventive control plan

As per section 88.94 of the Cannabis Regulations, a licence holder that conducts activities in relation to a cannabis extract or edible cannabis must prepare, retain, maintain and implement a written preventive control plan for any activity they conduct in respect of the cannabis or anything that will be used as an ingredient in the production of the cannabis extract or edible cannabis.

The preventive control plan must include the following criteria:

• A description of the measures for ensuring that the applicable requirements of sections 101.3, 101.4, 102, 102.2, 102.3, 102.5 and 102.6 are met;
• In relation to the applicable requirements of these Cannabis Regulations:
  • A description of the biological, chemical and physical hazards that are identified under subsec-tion 88.93(1) that present a risk of contamination of the cannabis extract, edible cannabis or anything that will be used as an ingredient in the production of the cannabis extract or edible cannabis;
  • A description of the control measures for pre-venting or eliminating the hazards referred to in subparagraph 88.93(1)(i) or reducing them to an acceptable level and the evidence that the control measures are effective;
  • A description of the critical control points, of the related control measures and of the evidence that the control measures are effective;
  • A description of the critical limits for each critical control point;
  • The procedures for monitoring the critical con-trol points in relation to their critical limits;
  • The corrective action procedures for each critical control point;
  • The procedures for verifying that the imple-mentation of the preventive control plan results in compliance with these Regulations; and
  • Documents that substantiate that the prevent-ive control plan has been implemented with respect to subparagraphs 88.93(1)(i) to (vii).
• Supporting documents that show evidence of the information recorded under subparagraphs 88.94(1)(a) and subparagraphs 88.94(1)(b)(i) to (vii).

In addition, each document referred to in subparagraph 88.94(1)(2)(b)(viii) must be retained for at least two years after the day on which it is prepared.

5.3 Testing requirements

As per section 89 of the Cannabis Regulations, licence holders must not sell cannabis products to a person authorized under a provincial Act referred to in subsection 69(1) of the Act or to a holder of a licence for sale, or export cannabis products, unless the applicable requirements set out in sections 90 to 92 of the Cannabis Regulations have been met. This section of the guide outlines these requirements in further detail.

5.3.1 Testing Requirements

5.3.1.1 Testing for phytocannabinoids

As per section 90 of the Cannabis Regulations, testing for the quantity or concentration, as the case may be, of THC, THCA, CBD and CBDA must be conducted on each lot or batch of cannabis, other than cannabis plants or cannabis plant seeds, that is or will become a cannabis product or is or will be contained in a cannabis accessory that is or will become a cannabis product.

The testing must be conducted on the final form of the cannabis, either before or after it - or the cannabis accessory that contains it - is packaged and labelled as a cannabis product.

5.3.1.2 Testing for contaminants

As per section 91 of the Cannabis Regulations, testing for microbial and chemical contaminants (e.g., residual solvents, heavy metals, aflatoxins, etc.) - other than residues of a pest control product or its components or derivatives - must be conducted on the following:

• Each lot or batch of cannabis - other than cannabis plants, cannabis plant seeds, or edible cannabis - that is or will become a cannabis product, or, is or will be contained in a cannabis accessory that is or will become a cannabis product.
  • Testing on this lot or batch of cannabis must be conducted on the final form of the cannabis, either before or after it - or the cannabis accessory that contains it - is packaged and labelled as a cannabis product.
• Each lot or batch of cannabis - other than cannabis plant seeds - that is used to produce a lot or batch of cannabis - other than cannabis plants, cannabis plant seeds, or edible cannabis that is or will become a cannabis product, or is or will be contained in a cannabis accessory that is or will become a cannabis product, or is used to produce edible cannabis that is or will become a cannabis product, or is or will be contained in a cannabis accessory that is or will become a cannabis product.
  • Testing of this lot or batch of cannabis must be conducted after the final step in the production process during which the microbial and chemical contaminants - other than residues of a pest control product or its components or derivatives - could have been introduced or could be concentrated whichever is later.

The results of this testing must enable a determination of whether the contaminants, if any, are or will be within the tolerance limits referred to in subsection 93(3) or 94(2) or section 101.1 of the Cannabis Regulations, as the case may be.

The generally accepted tolerance limits for human use for a contaminant must be appropriate for the intended use and any reasonably foreseeable use of the cannabis product, except for edible cannabis which must be appropriate for product that is to be ingested, and they must be established in a publication referred to in Schedule B of the Food and Drugs Act.

There are a number of concepts that may be considered when determining whether a contaminant is or will be present at an acceptable level. These include, but are not limited to:

• Permitted daily exposure and concentration limits
  • The acceptable tolerance limits for some contaminants can be expressed as permitted daily exposures or concentration limits. In the event a permitted daily exposure has been determined for a contaminant, consideration must be given to whether the contaminant is present at a level at which the intended use and any reasonably foreseeable use of that product (i.e. the anticipated amount used daily, route of exposure) would not result in a permitted daily exposure being exceeded. Publications in Schedule B to the Food and Drugs Act outline how to go about determining an appropriate limit for contaminants so that a permitted daily exposure is not exceeded.
• Intended and reasonably foreseeable use of the cannabis product
  • Publications listed in Schedule B to the Food and Drugs Act contain general chapters for categories of products (e.g., European Pharmacopoeia (Ph. Eur.) 1433 Herbal Drugs) as well as for different types of contaminants (e.g., Ph. Eur. 5.20 Elemental Impurities). Some of these chapters may contain different quality specifications for the contaminant in question, thus it is important to consider the intended or reasonably foreseeable use of the cannabis product to determine whether the level of a contaminant would be within generally accepted tolerance limits. For example, the toxicity of heavy metals can vary greatly depending on the route of exposure and as such, generally accepted tolerance limits are different for products for orally ingested versus inhaled. While the general chapter for herbal drugs Ph. Eur. 1433 contains specifications for heavy metals including cadmium, lead and mercury, these levels are appropriate as limits for products that are orally ingested; however, the general chapter for elemental impurities Ph. Eur. 2.20 contains specification for heavy metals for which the limits are more appropriate for products that may be reasonably foreseeably consumed via inhalation, such as dried cannabis intended to be smoked or vaporized.
  • Other contaminants must be similarly considered based on the cannabis product's intended use and reasonably foreseeable use, including route of administration or exposure. For example, a cannabis product intended for vaginal use may be considered contaminated if it contained Candida albicans since this microorganism would present the risk of causing a yeast infection. The licence holder may consider identifying a publication referred to in Schedule B of the Food and Drugs Act for which tolerance limit exists (e.g., the acceptance criterion is an absence of Candida albicans in vaginal products, as specified in Ph. Eur. 5.1.4, Microbiological Quality of Non-sterile Pharmaceutical Preparations and Substances for Pharmaceutical Use).
  • When selecting generally accepted tolerance limits, the licence holder must consider the intended use and the reasonably foreseeable use in which the cannabis product, except in the case of edible cannabis will be used. This assessment may include an evaluation of similar products available on the market, or common uses of the product.

It is the responsibility of licence holders to ensure that they periodically review the selected publications referred to in Schedule B of the Food and Drugs Act to ensure that the contaminant testing and selected tolerance limits meet the requirements of the Cannabis Regulations.

Refer to Table 1 for further details on the timing of testing for contaminants.

5.3.1.3 Dissolution and disintegration testing

As per section 91.1 of the Cannabis Regulations, if cannabis, or a cannabis accessory that con-tains cannabis, is or will become a cannabis product to which subsection 95(1) applies, testing must be conducted on each lot or batch of the cannabis or cannabis accessory to determine whether the requirements referred to in that subsection are, or will be, met.

The testing must be conducted on the final form of the cannabis, either before or after it - or the cannabis accessory that contains it - is packaged and labelled as a cannabis product.

5.3.1.4 Testing method

As per section 92 of the Cannabis Regulations, testing that is conducted under sections 90 to 91.1 - or to determine whether the requirements under Part 6 are, or will be, met - must be conducted using validated meth-ods on a representative sample of each lot or batch of can-nabis or cannabis accessory that contains cannabis.

A portion of this 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 to enable a determination of the following:

• Whether the lot or batch meets the requirements of section 81 and the requirements of subsections 93(3), 94(2) or 95(1), or section 101.1, as applicable; and
• The quantity or concentration of THC, THCA, CBD, and CBDA.

Testing must be performed against the identified pharmacopeial specification(s), as applicable before a lot or batch of cannabis product is made available for sale. The specification(s) against which the cannabis is to be tested must be identified; documented; supported by adequate justification, including an assessment of the intended and reasonably foreseeable use as per section 5.3.1.2; and, where applicable, approved by the QAP prior to testing. Licence holders should refer to section 5.3.1.2 for additional information on selecting tolerance limits.

The testing must be conducted using validated methods, as per subsection 92(1) of the Cannabis Regulations. Licence holders are responsible for demonstrating that the methods used for testing were validated prior to being used. The results of validation studies must be documented and maintained in accordance with section 231 of the Cannabis Regulations.

Licence holders must have approved SOP(s) in place to describe the testing activities. The SOP(s) may include reference standards and controls. Licence holders must maintain records summarizing testing protocols followed (including the Schedule B standard chosen, and the test methods and associated specifications to be used) and detailed testing results for each batch or lot of cannabis.

Licence holders may either conduct testing for phytocannabinoids, contaminants (other than residues of pest control products), or dissolution and disintegration in-house, or rely on a third party who holds a Health Canada licence under the Cannabis Act for testing of their cannabis. However, if testing is performed by a third party, it is the licence holder's responsibility to:

• Ensure that the third-party testing facility holds a valid Health Canada licence for analytical testing and that the licence holder is eligible to possess and conduct activities with cannabis
• Ensure that the third-party testing facility is using validated methods. This may include assessing the third-party testing facility's method validation(s) to ensure suitability, and maintaining records of this assessment
• Ensure that the third-party testing facility uses the appropriate analytical methods that correspond to the licence holder's approved specifications captured in the licence holder's approved SOP(s)
• Establish a list of the specifications and provide it to the third-party testing facility prior to conducting any testing for phytocannabinoids, contaminants (other than residues of pest control products), or dissolution and disintegration testing

The samples used for testing must be representative of the lot or batch being tested and intended for sale. Licence holders should refer to section 5.3.2 of this guide for additional information regarding representative sampling.

The samples sent for testing should have undergone all required processing (e.g., drying, milling, freezing) and, subject to completion of the testing, should otherwise be ready for assessment (where applicable) prior to approving the lot or batch for sale or export.

If a test result is outside of the identified specification, the product must not be approved for sale or export. Licence holders should not disregard test results that are out-of-specification (OOS) without scientific justification. OOS test results should be documented and investigated to determine the cause. The steps to be taken as part of an investigation in response to an OOS result (e.g., root cause, description of corrective actions and preventative actions carried out, and conclusions) should be outlined in the licence holder's approved SOPs for testing.

Licence holders should not repeatedly test the product until the result(s) fall within the identified specification(s) (e.g., microbial and chemical contaminant testing) or until the desired result is obtained (e.g., quantity or concentration of THC or CBD content). If licence holders choose to conduct multiple tests, they must do so in accordance with an approved SOP that outlines pre-determined criteria for when additional testing, including retesting, would be permitted. If licence holders permit retests (whether retesting the same sample, or testing a new sample), the maximum number of retests that can be performed should be documented in the SOP, along with the criteria for when the retest would be permitted. When conducting testing, licence holders must always ensure that their validated methods are being followed.

Any additional processing, alterations or secondary treatments, and subsequent testing, that might be done on a lot or batch of cannabis after initial testing has been conducted should be justified in accordance with pre-determined criteria that have been outlined in an SOP, indicating when these additional activities would be permitted. In addition, the cannabis that has been processed, altered or treated after initial testing may require full testing and evaluation against all specifications prior to being made available for sale as a cannabis product. Licence holders should refer to section 5.3.1.2 for additional information on the stage of testing.

The release specification(s) for the cannabis product to be approved for sale should be identified, documented, supported by adequate justification and, where applicable, approved by the QAP prior to the cannabis product being released for sale.

The quality of the cannabis could be adversely affected during processing activities (e.g., packaging) conducted after testing. The licence holder is responsible for ensuring the quality of the cannabis after testing and until it is sold.

Further to some of the testing required under Parts 5 and to determine whether the applicable requirements in Part 6 of the Cannabis Regulations are, or will be, met, the licence holder must be able to determine the following:

• Whether any pest control products were used on a lot or batch [sections 81 and 92.2, 93(2), 93(4), 94(1), 101(3)(b), 102.1(2)(b)]. For more information, refer to the Mandatory cannabis testing for pesticide active ingredients - Requirements.
• The THC quantities or concentrations, taking into consideration the potential to convert THCA into THC, of the following:
  • Each discrete unit of a cannabis product (milligrams of THC) intended for ingestion, or nasal, rectal or vaginal use (section 96)
  • Cannabis extract or cannabis topical that is a cannabis product or that is contained in a cannabis accessory that is a cannabis product (milligrams of THC per immediate container) (section 101.2)
  • Edible cannabis that is a cannabis product or that is contained in a cannabis accessory that is a cannabis product (milligrams of THC per immediate container) (section 102.7)
  • Each activation of the following cannabis accessories that dispenses cannabis extract (milligrams of THC) (section 103.2):
    • A cannabis accessory that is a cannabis product and that dispenses a cannabis extract that is intended for ingestion or nasal, rectal or vaginal use
    • A cannabis accessory that is packaged with, and that is intended to dispense, a cannabis extract that is a cannabis product and that is intended for ingestion or nasal, rectal or vaginal use
• Variability limits of acannabis extract, a cannabis topical or edible cannabis that is a cannabis product - or that is contained in a cannabis accessory that is a cannabis product and variability of divisible cannabis products or of discrete units (sections 97 and 97.1).

5.3.2 Representative sample and quantity

As per section 92 of the Cannabis Regulations, a representative sample of each lot or batch of cannabis or cannabis accessory must be taken for the purposes of each test referred to in sections 90 to 91.1 or to determine whether the applicable requirements in Part 6 are, or will be, met. A portion of this 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 to enable a determination of whether the lot or batch meets the following requirements:

• Microbial and chemical contaminants (subsections 91(1), 93(3), 94(2)and section 101.1 of the Cannabis Regulations)
• Dissolution and disintegration (section 91.1 and subsection 95(1) of the Cannabis Regulations)
• Quantities or concentrations of THC, THCA, CBD and CBDA (subsection 90(1) of the Cannabis Regulations)
• Pest control product (sections 81, 92.2, 93(2), 94(1) and 101(3)(b) of the Cannabis Regulations)

The sample used for testing must be representative of the lot or batch (i.e. a quantity of cannabis whose characteristics represent, as accurately as possible, the entire lot or batch) of cannabis or cannabis accessory that contains cannabis that would be sold or exported. The quantity and quality of the samples should be proportional to and reflective of the total lot or batch. In addition, the portion of sample(s) retained for one year from the last sale of any portion of each lot or batch of cannabis or cannabis accessory, must be representative of the sample(s) that were taken at the time of testing to meet the requirements of sections 90 to 91.1 for each required test. For example, for edible cannabis, the sample retained for microbial and chemical contaminants should be on each lot or batch of cannabis that was used to produce edible cannabis as per subparagraph 91(1)(ii) and testing for phytocannabinoids must be on the final form of cannabis.

The samples must be collected according to the licence holder's approved SOP(s), and sampling procedures must be carried out under sanitary conditions, as per Part 5 of the Cannabis Regulations.

The samples must be maintained in accordance with an approved SOP. The samples must be stored under appropriate conditions that do not adversely affect their integrity. Additionally, they should be stored according to the conditions set out on the label, as applicable, and in a manner that enables immediate identification. In the case where samples of cannabis product are retained, the licence holder may choose to keep samples in the same immediate containers in which they are sold, or in containers that are equivalent with respect to stability.

In the case where there are no remaining portions of a lot or batch of cannabis that could be used for testing, retained samples may be required for testing when conducting investigations, such as those pertaining to quality-related complaints. A sample must be maintained to allow Health Canada to conduct additional testing as required, until the one year period after the date of the last sale of any portion of the lot or batch elapses. Licence holder may choose to keep a sample for their own testing purposes.

6.0 Contact us

Licence holders who have questions about the information or requirements in this guide are invited to contact the Controlled Substances and Cannabis Branch at cannabis@canada.ca.

For questions related to Health Canada inspections, licence holders may contact the Regulatory Operations and Enforcement Branch at hc.inspectionscannabisinspections.sc@canada.ca.

7.0 Feedback-Help us improve

Health Canada is committed to providing all stakeholders with timely, accurate and reliable information. This includes providing applicants and licence holders with the information they need to comply with the Cannabis Act and its Regulations.

Health Canada appreciates receiving feedback on whether this guide was useful, and welcomes your suggestions for improvement. Email your feedback to cannabis@canada.ca and indicate in the subject line Feedback on the Good Production Practices Guide for Cannabis.

Your comments will help us improve this guide.

Appendix A: GPP requirements by licence class

Table 2 provides a general summary of the GPP requirements that apply for each licence class. However, different GPP requirements may apply depending on the activities associated with each individual licence. Refer to the Cannabis Regulations for further information.

Appendix B: GPP requirements by class of cannabis

Tables 3, 4 and 5 provide a general summary of the GPP requirements that apply for each class of cannabis. However, different GPP requirements may apply depending on the activities associated with each individual licence. Refer to the Cannabis Regulations for further information.

Appendix C: Part 2 - Licensing requirements related to GPP

Table 6 provides requirements and additional information pertaining to the QAP - section 19 of the Cannabis Regulations.

Appendix D: Part 6 - Cannabis products requirements related to GPP

Table 7 provides some of the requirements and additional information pertaining to the cannabis product specifications outlined in sections 92 - 104 of Part 6 associated with the cannabis testing requirements outlined in sections 90 and 91 of Part 5 of the Cannabis Regulations. Table 8 provides additional details on maximum quantities of various cannabis forms.

Appendix E: Part 11 - Retention of documents and information requirements related to GPP

Table 9 summarizes the record keeping requirements pertaining to GPP. It provides the relevant section references between Parts 5 and 11.

Appendix F: Preventive control plan best practices

Table 10 provides an overview of the GPP requirements for sections 88.93 and 88.94 of the Cannabis Regulations, specific to holders of a licence for processing that produce a cannabis extract or edible cannabis.