Create your plan: Preventive control plan for cannabis extracts and edible cannabis

On this page

• Create your plan
• Conduct hazard analysis
• Determine critical control points and their critical limits
• Corrective action procedures
• Verify your plan
• Cannabis type-specific requirements

Create your plan

Before you start creating your preventive control plan, it's important that you have key members of your team in place who understand your cannabis production process, including the ingredients, equipment, and packaging used to produce your cannabis extract or edible cannabis. Your team should include a quality assurance person (QAP), as well as other personnel who can support them with knowledge and expertise on hazard identification, the control of hazards and your production process.

Recommended steps to create your preventive control plan are as follows.

Step 1: Hazard identification, analysis and control measures

• Identify, list and analyze all potential biological, chemical, and physical hazards associated with each ingredient, activity or step used in processing, handling and storage of cannabis extracts or edible cannabis
• Identify measures to ensure applicable requirements for cannabis extracts or edible cannabis are met as detailed in the regulations
• Describe the measures that would control each hazard and requirement (the control measures)

Step 2: Critical control points and critical limit determination

• Determine and describe the critical control points (described below)
• Describe the related control measures, including the evidence that the control measures are effective
• Establish and describe the critical limits for each critical control points

Step 3: Monitoring procedure for each critical control point

• Develop procedures for monitoring critical control points in relation to their critical limits (described below)

Step 4: Corrective action procedures for each critical control point

• Develop a corrective action procedure for each critical control point to address any deviations from critical limits or the control measures in the plan

Step 5: Verification procedures for implementing your preventive control plan

• Develop procedures to demonstrate that your plan is implemented as written and is effective

Step 6: Supporting documentation

• Ensure your preventive control plan has supporting documents to demonstrate measures you have taken meet the requirements

Conduct hazard analysis

You must identify and analyze the hazards that present a risk of contamination to the cannabis or ingredients during the production of cannabis extracts or edible cannabis.

This section describes how to identify and analyze hazards in the production of cannabis extracts or edible cannabis, including:

• types of hazards
• identify hazards
• analyze and evaluate hazards
• determine control measures

Types of hazards

There are 3 different types of hazards:

• biological hazards
• chemical hazards
• physical hazards

Biological hazards

Biological hazards include microorganisms such as bacteria, viruses, parasites, fungi, and moulds. Some microorganisms, such as Salmonella spp., Listeria monocytogenes, Bacillus cereus, E. coli O157:H7 and Campylobacter jejuni, are harmful and can cause illnesses by their presence alone. Other microorganisms, such as Clostridium botulinum and Staphylococcus aureus, produce harmful toxins. For example, botulism caused by Clostridium botulinum can have severe health consequences.

Examples of sources of biological hazards include:

• incoming ingredients, including raw materials
• cross-contamination in the processing or storage environments
• employee traffic flow
• contact surfaces
• environment
• water
• insects and rodents

Chemical hazards

Chemical hazards may be naturally occurring or manufactured and can be introduced during any stage of cannabis extract or edible cannabis processing. For example, allergens may be introduced either by being present in an ingredient or as a part of an ingredient, or through cross-contamination during processing.

Examples of chemical hazards may include:

• chemicals intentionally used in cannabis extract and edible cannabis processing such as ingredients, processing aids, and food additives
• chemical contamination from equipment such as lead-soldered seams
• industrial chemicals such as cleaning agents, oils, gasoline, lubricants, ammonia
• agricultural chemicals such as pesticides, antibiotics, fungicides, rodenticides, algicides, fertilizers
• nutrients such as the over addition of vitamins and minerals into edible cannabis
• food allergens

Physical hazards

Physical hazards include unwanted materials that may be introduced anywhere along the production chain, from primary production up to and including packaging and labelling. Unwanted materials can be introduced by anything or anyone coming in contact with the cannabis, cannabis extract, or edible cannabis, such as people who handle cannabis, or during processing, transportation or storage. The unwanted materials are considered hazardous if they can result in illness or injury to anyone who consumes or uses the cannabis extract or edible cannabis.

Examples of physical hazards include:

• stones, rocks and dirt (commonly found in fruits, vegetables and other foods that are grown close to the soil)
• metal (commonly associated with processing activities such as cutting, slicing or grinding operations, as well as packaging materials or containers such as metal shards, staples and nails)
• jewelry and personal items (resulting from poor handling practices)
• glass or other contaminants from packaging materials or containers, or from the processing environment, for example, uncovered light fixtures
• wood splinters from broken pallets or packaging material
• flaking paint from overhead structures or equipment
• insects and rodent droppings

Identify hazards

To properly identify a hazard, you need to understand your cannabis extract or edible cannabis product and all its processing steps, be knowledgeable about the hazards associated at each processing step and have a good understanding of how they can be controlled.

Hazard identification can be based on:

• your knowledge and experience with the facility's operations
• documented production issues such as files on production rework, returned products, product complaints and recalls
• communication with third party suppliers to gain knowledge of their product (for example, allergens in an ingredient)
• external references, for example:
• reference texts, for example, food biology, food chemistry, food processing, chemical extractions
• scientific publications
• information available from industry associations and governments, such as hazard guides, generic Hazard Analysis Critical Control Point (HACCP) models and reports
• other sources of hazard information: consumer complaints, notices from suppliers, advisories from a government authority (for example, provincial health authority or federal health department), notices from a distributor, retailer, customer or foreign competent authority
• The Canadian Food Inspection Agency's Reference database for hazard identification is a reference tool that can help food businesses identify food safety hazards associated with their food and operation. This may help you to identify hazards associated with processing or producing cannabis extracts or edible cannabis.

Once identified, a list of biological, chemical and physical hazards that may reasonably be expected or likely to occur should be created. These hazards may come from:

• all inputs (for example, raw materials, ingredients, additives, packaging material) and the environment
• each processing step in the production of a cannabis extract or edible cannabis, from receiving of raw materials, to processing, to storage and shipping
• traffic flow, which is illustrated on the floor plan of the facility, showing the various areas where people, equipment, cannabis and ingredients are found and are potential points of cross-contamination

In the list of identified hazards, you should include the name of the pathogen (for example, Listeria monocytogenes) or the type of physical hazard (for example, glass fragment), the conditions that are associated with it (for example, presence, survival, growth, or contamination), and the reason for the hazard. For example:

• presence of metal fragments due to a broken mixer paddle
• presence of Salmonella on packaging material due to contamination with fecal material from pests (for example, rodents, birds and insects) during storage
• contamination of allergen-free ingredients with allergens due to inadequate separation from allergen-containing ingredients in bulk storage
• survival of Listeria monocytogenes due to inadequate time and temperature during cooking

As part of your preventive control plan, documents must be included to explain how you've identified the hazards associated with the cannabis extract or edible cannabis. These may include:

• the information used to conduct the hazard analysis such as process flow diagrams and product descriptions
• consumer complaints
• scientific research
• a record of test results
• certificates of analysis provided by a supplier

Analyze and evaluate hazards

With the hazards identified, you will need to determine how likely each hazard is to occur and how severely it may affect the consumer's health. You will also need to record why a hazard isn't likely to occur, and if a hazard is likely to occur, why it is or is not significant.

When evaluating the likelihood that a hazard will occur, consider:

• existing procedures and control measures that are in place to meet good production practices
• equipment used in manufacturing and processing, and the specific parameters important to controlling, reducing or preventing hazards
• equipment and facility sanitation
• experiences and data from past outbreaks such as food-related outbreaks, scientific literature, and corporate historical information on recalls and customer complaints
• effectiveness of preventive controls required under the Regulations, for example, a sanitation program and specific standard operating procedures (SOPs)

When evaluating the severity of a hazard, consider the:

• impact on public health and safety including the duration and seriousness of illness or injury that the hazard may cause
• susceptibility of certain consumers to be affected, based on population groups or age groups, for example, individuals using cannabis for medical purposes

A significant hazard is a hazard that is likely to occur and would severely affect the health of consumers if it's not controlled. If you miss a significant hazard, it won't be controlled leading to the potential for a significant impact on product quality and safety.

Determine control measures

For all potential hazards you've identified, you must determine how you will control each hazard so that it's prevented, eliminated or reduced to an acceptable level. For each control measure, you must have evidence that the control measure is effective.

The control measures should be described as follows:

• what: a description of the tasks needed to carry out the control measure (such as standard operating procedures)
• how: details of how the tasks are carried out
• when: the frequency of the tasks to be carried out (for example, hourly, weekly, monthly)
• who: the persons or teams responsible for carrying out the task
• records: the forms to be used for the day-to-day collection of information, such as the forms used to record delivery of tasks and controls

Evidence could include:

• scientific literature (published information from regulatory authorities or scientific journals and literature demonstrating that the control measures have been confirmed to be effective)
• collection of specific data to assess the effectiveness of your control measure at a set period of time during regular operating conditions
• validation studies including challenge studies
• predictive modelling such as mathematical models or equations to predict the growth and activity of a microorganism in a product over time
• representative sampling and validated testing methods
• performed at an accredited laboratory
• using recognized test methods such as those found in Health Canada's Compendium of food allergen methodologies, Compendium of methods for chemical analysis of food, and Compendium of analytical methods
• a history of overall effectiveness and reliability, for example, for an equipment confirmed by independent bodies (such as equipment manufacturers or other industry parties)
• guidelines from internationally recognized organizations, such as Codex Alimentarius

The type and amount of evidence needed to demonstrate effectiveness of a control measure (or a combination of control measures) depends on the type of control measure and on the nature of the hazards. Assess each control measure on a case-by-case basis.

• Control measures for the maintenance and operation of an establishment in a clean and sanitary condition don't generally have a quantitative effect on specific hazards, meaning that the impact can't be objectively measured. For these types of control measures, it's important that you:
• specify the reference that each control measure is based on
• confirm that the measure is effective when applied to each situation
• you can do this by observing the state and operation of your facility, conducting product or environmental sampling and testing, and conducting verification activities
• Control measures for significant hazards usually have a quantitative effect on specific hazards. For example, the time and temperature needed to reduce the numbers of a microorganism in a processing step, like pasteurization. The evidence for these types of control measures is often based on the collection and assessment of scientific, technical, and observational information.
• You can use pre-validated control measures (measures that have already been confirmed as effective) and conduct a literature review of references such as:
• publications issued by provincial, national or international governments
• scientific publications
• recommendations from the manufacturer of a processing equipment or packaging material
• When pre-validated control measures are used, there is no need to re-validate them provided the conditions of application are the same. However, it is important that you:
  • specify the reference that the control measure is based on
  • monitor that they're implemented as intended
  • verify that they're effective for their operation, for example, if using a pH or water activity (aw) level that is already confirmed as effective to control a pathogen, you would only need to show that you can consistently achieve that specified level in cannabis edibles
• You can also use new or alternative control measures.
  • You will need to complete a scientific validation study (involving study design and collecting and analyzing their own scientific data) to generate the evidence needed to prove that these measures are effective

Determine critical control points and their critical limits

As part of your preventive control plan, you need to include a description of the critical control points, the related control measures and the evidence that the control measures are effective.

A critical control point is a step in your process where a control measure is applied with clear critical limits. A critical control point is essential to prevent, eliminate or reduce to an acceptable level the identified hazards.

Critical limits are the measurable or observable pre-set values or criteria that must be met at a critical control point to control the identified hazards.

A critical control point must have realistic and appropriate critical limits that can be monitored and measured.

Determine critical control points

After conducting your hazard analysis, determine if there are any critical control points in your process.

In general, critical control point determination involves identifying and characterizing the hazards, the control measures, and the processing steps where the control is applied.

To determine if a step in your process is a critical control point, review the hazard analysis that you conducted and consider the following information for each hazard identified at a process step.

1. If a control measure at a process step doesn't exist to control a hazard and:
   • you have determined that this step in your process isn't necessary for product safety, then this step in your process isn't a critical control point
   • you have determined that this step in your process is necessary for product safety, then you need to modify the step, process or product so that this step in your process does not affect the safety of the product
     • Control measures must exist if a step in your process is a critical control point
2. If a control measure exists at a step in your process and this step is specifically designed to eliminate or reduce the likely occurrence of a hazard to an acceptable level, then this step is a critical control point
3. If you have determined that the failure of a control measure at a step in your process is unlikely to increase the hazard to an unacceptable level, then this step in your process isn't a critical control point
4. For a hazard identified at a step in your process, if a subsequent step in your process will eliminate the hazard or reduce it to an acceptable level, then the initial step isn't a critical control point

A critical control point can also be a step taken to control the identified hazard directly. This can be a cooking step to control biological pathogens, a metal detector to detect metal fragments, or cooling or freezing ingredients or products to control pathogens.

In a typical facility, the location of hazards and the number of critical control points depend on the equipment, site layout, ingredients, processes used, and other factors.

Examples of processing steps that may be considered critical control points are:

• cooking (for example, a specified heat process at a given time and temperature designed to eliminate a specific microorganism)
• cooling (for example, reducing the internal temperature of a product to a given temperature within a specified time to prevent the growth of pathogens)
• dehydration (for example, reducing the water activity of a product to a specific level to prevent the growth of pathogens)
• formulation (for example, adjusting the pH of a food to a specific value that will prevent toxin formation)
• pasteurization (for example, a specified heat process at a given time and temperature designed to eliminate a specific microorganism)
• sifting, filtering, grinding (for example, the final filter used in a beverage facility to eliminate physical hazards)
• metal detection (for example, metal detector used at the end of the processing line to eliminate presence of metal)

There is no set number of critical control points required in a preventive control plan. Depending on the products and activities at your site, there may not be any critical control points in your preventive control plan. Critical control points must be determined for each specific hazard in the cannabis extract or edible cannabis processing and handling system and be appropriate to that specific system.

Another way of identifying critical control points is the use of a decision tree where a series of questions guides you through this process. For example, see a decision tree developed by Codex Alimentarius, an international food code.

Establish critical limits for a critical control point

For each critical control point in your process, you must establish your critical limits or criteria that prevent, eliminate or reduce the hazard to an acceptable level.
Critical limits should be:

• specific, accurate and precise
• realistic, reasonable and achievable
• measurable or easily monitored in real-time
• able to be documented and verified

Evaluating critical limits should produce an immediate result to ensure a quick decision on whether the identified hazard is controlled to an acceptable level. It is important that your critical limits:

• be supported by scientific data
• meet Canadian standards and guidelines as applicable (such as the Cannabis Regulations, the Food and Drug Regulations, and the Pest Control Products Regulations)

Critical limits may be quantitative (for example, length, height, area, volume, weight, speed, time, temperature, humidity) or qualitative (for example, other types of properties that can be confirmed by a visual inspection, such as color of the product or presence of air bubbles). Critical limits based on qualitative data should be supported further with descriptions or instructions that help those responsible for monitoring the critical control point understand the critical limit and ensure consistent application.

Examples of criteria for a critical limit:

• a minimum temperature and time for a cooking process that must be achieved to destroy harmful bacteria
• a specific pH to prevent the growth of bacteria
• a level of a preservative to control the growth of bacteria

You can obtain criteria from many sources:

• regulatory standards and guidelines
• review of published research documents
• experimental results (for example, in-house experiments, contract laboratory studies)
• experts (for example, thermal process authorities, consultants, food scientists, microbiologists, equipment manufacturers, sanitarians, academics)
• industry best practice

Monitor critical control points

You must develop procedures to monitor your critical limits at each critical control point.

Monitoring procedures describe any tests, measurements or observations of the critical limits that will be conducted to assess whether:

• critical limits are met
• control measures are functioning as intended

Your monitoring procedures should:

• provide a description of the activities performed to monitor the critical limits such as:
• the tests performed
• measurements to be taken or observations to be made
• equipment or instruments used in monitoring
• provide a detailed description of how the activities are carried out such as:
• test methods
• instructions on how to conduct the test, measurements or observations
• establish a monitoring frequency that is appropriate considering these:
• a set frequency for carrying out the monitoring procedure
• monitoring can be continuous or intermittent
• monitoring frequency should be specific and measurable (for example, "as required" is not an appropriate frequency)
• time-based such as hourly, daily, or production-based such as each lot, each load, or each shipment
• identify the job title of the person responsible for conducting the different activities under the monitoring procedures and evaluating the results
• list the records used to document the results of the monitoring activities

Types of monitoring activities may include:

• physical measurements such as time, weight, temperature
• chemical measurements such as pH, water activity and salt
• microbiological testing, for example:
• microbiological analysis of raw materials before their use in processing (for example, analytical results in dried milk used in an edible cannabis)
• microbiological analysis of finished edible cannabis product before their release to highly sensitive consumers (for example, medical clients)

Corrective action procedures

You must develop corrective action procedures for every critical control point. They are the steps to be taken to address any deviations from the critical limits or the control measures in the preventive control plan.

When your control measures or processes don't meet a critical limit, it indicates that a product safety hazard may have occurred, and that unsafe products may have been produced. Thus, corrective actions must be immediate and must trigger an automatic review of the preventive control plan.

Your corrective action procedures should:

• identify and isolate the affected products, evaluating their safety and stopping unsafe products from reaching the market
• determine the root cause of the deviation, and prevent recurrence
• control the cannabis extract or edible cannabis by:
• determining if the affected or potentially affected cannabis extract or edible cannabis complies with the Regulations
• controlling non-compliant product through a product hold and product recall, if necessary
• bringing affected cannabis extracts or edible cannabis into compliance (including validation) or disposing of it as appropriate
• record the failure in meeting the critical limit and the corrective actions taken

Corrective action procedures are required for each critical control point. Corrective actions are specific for each hazard and for each critical control point.

Every written corrective action procedure should answer basic questions about who, what, when, and how to document the corrective actions.

The typical sequence of events involved in a corrective action by licence holders is as follows.

1. Re-establish control, investigate and identify all affected lots or batches of product and any unsafe product that entered the trade supply. For example:
• stop the line or process
• identify and segregate affected product
• start investigating, identifying, following up and conducting a recall if an unsafe cannabis product has entered the marketplace
• inform regulatory officials as appropriate
2. Find the root cause of the deviation and prevent recurrence
• investigate and determine what went wrong
• adjust the process to bring it back under control
3. Assess if the product is still safe to consume or use and how the product will be dealt with after the assessment
4. Determine whether modification of your plan is necessary
5. Document the details including observations, corrective actions taken, and control measures to prevent recurrence

Verify your preventive control plan

You must develop procedures for verifying the implementation and effectiveness of your preventive control plan.

Verification procedures should describe what you will do to verify or to confirm that all control measures, especially those identified as critical control points, and other parts and processes in your preventive control plan are implemented consistently and are effective in ensuring safe and compliant cannabis extracts or edible cannabis.

Verification procedures don't only involve the critical control points but rather the preventive control plan as a whole.

The procedure includes details such as:

• what: the control measures and other parts and processes in your preventive control plan
• who: the job title of the person responsible for the verification procedure
• ideally, this would be a different person than the person who carried out the control measure, corrective actions, and monitoring activities
• how: the verification activities to be conducted and what to do when it's not consistently implemented or isn't effective
• when: the frequency of the verification activity
• where: where the records of the verification activities are kept

All critical control point-related activities (critical limits, critical control point monitoring, and corrective actions) necessary to ensure compliance with the preventive control plan must be verified. This includes establishing that:

• all the responsible individuals defined in your plan are performing in accordance with the preventive control plan
• all monitoring procedures are appropriate and being conducted at the appropriate frequency
• the corrective action plan is appropriate and being implemented as described

It may be necessary to check the adequacy of monitoring and to provide confirmation that the critical control point is, in fact, controlling the hazards by performing additional sampling and testing.

One aspect of verification activity is the review of all critical control point records, including monitoring records, corrective action records, and calibration records. Verifying records ensures that they're prepared and implemented according to the procedure described in the preventive control plan. This includes evaluation to ensure:

• monitoring is being performed using appropriate procedures and at an appropriate frequency
• responsible individuals are identified
• documents are properly signed
• all events where critical limits are not met are identified and recorded
• corrective actions are conducted according to the plan

Examples of verification activities are:

• observing an employee performing monitoring activities to ensure that the written procedures are being followed
• observing corrective actions taken by an employee to ensure that the written procedures are being followed
• reviewing records documenting the monitoring activity to ensure the proper version of the record is used, records are complete and filled out according to written procedures
• reviewing records documenting the actions taken in response to a deviation
• sampling and testing the environment or the cannabis to confirm its safety
• verifying the calibration of equipment
• interviewing and observing employees to ensure written policies and procedures are followed

Cannabis type-specific requirements

In your preventive control plan, you must describe how you will ensure that specific requirements for cannabis extracts and edible cannabis listed in this page are met.

This section includes restrictions or limits and conditions that cannabis extracts and edible cannabis are subject to:

• cannabis extracts
• ingredients
• uniform distribution
• edible cannabis
• ingredients
• hermetically sealed containers
• irradiation

Cannabis extracts

Ingredients

Ingredients permitted in your cannabis extracts are:

• carrier substances, for example, MCT oil
• flavouring agents, for example, food additives that add flavour
• any substances necessary to maintain the quality or stability of the product

Ingredients not permitted in your cannabis extracts are:

• Any ingredients not listed above
• sugars, sweeteners, or sweetening agents
• any substances listed in Column 1 of Schedule 2 to the Tobacco and Vaping Act
• ethyl alcohol

However, there are some exemptions to these prohibitions:

• naturally occurring: an ingredient may contain sugars, sweeteners or sweetening agents or a substance listed in Column 1 of Schedule 2 to the Tobacco and Vaping Products Act if it is naturally present in the ingredient at a level that is not above the naturally occurring level for that ingredient;
• vitamins: a vitamin may be used despite being listed in Column 1 of Schedule 2 to the Tobacco and Vaping Products Act if it is used in an amount that does not exceed what is necessary to maintain the quality or stability of the cannabis product
• ingested cannabis: ethyl alcohol may be used for an ingested cannabis extract, if the net weight of the cannabis extract in each immediate container does not exceed 7.5 g

Additionally, for inhaled cannabis extracts, ingredients – other than flavouring agent – must comply with a standard set out in one of the publications referred to in Schedule B to the Food and Drugs Act.

Uniform distribution

The cannabinoids and terpenes must be uniformly distributed throughout the cannabis extract. For example, in a lot or batch of bottled cannabis extract, the amount of THC in every bottle should be the same.

Edible cannabis

Ingredients

Ingredients permitted in your edible cannabis are:

• food
• food additives, subject to certain conditions (see below)

Ingredients not permitted in your edible cannabis are:

• any ingredient that is not food or a food additive
• food that has a Temporary marketing authorization letter issued under subsection B.01.054(1) of the Food and Drug Regulations;
• a supplemented food within the meaning of section B.01.001 of those Regulations;
• a food in respect of which the manufacturer is exempt from the application of the Food and Drug Regulations, in accordance with section 32 or 33 of the Regulations Amending the Food and Drug Regulations and the Cannabis Regulations (Supplemented Foods);
• added caffeine or caffeine citrate

Ingredients permitted in your edible cannabis with conditions are:

• meat products, poultry products or fish
• condition: if its water activity doesn't exceed 0.85 in certain specified conditions; and
• condition: if it's produced by a person authorized under a provincial authority or imported or produced by a person authorized under the Safe Food for Canadians Act
• food you produce
• condition: if the sale of the food isn't prohibited under section 4 of the Food and Drugs Act; and
• condition: if the food isn't a meat product, poultry product or fish
• food additives (including vitamins and mineral nutrients)
• condition: if the edible cannabis would be a food that is the subject of a marketing authorization under the Food and Drugs Act (if the product did not contain cannabis)
• condition: if the food additive meets the conditions of the marketing authorization, including any maximum levels used
• caffeine
• condition: if it comes from ingredients that naturally contain caffeine (for example, dark chocolate); and
• condition: if the total amount of caffeine in the edible cannabis isn't more than 30 mg per immediate container
• ethyl alcohol
• condition: if the concentration is no more than 0.5% w/w of the edible cannabis

Hermetically sealed containers

The components of edible cannabis products that are packaged in hermetically sealed containers (that is, containers that prevent the entry of micro-organisms) must have, at a temperature of 22 +/- 2°C:

• have a pH that is less than 4.6, or
• have a water activity that is less than 0.85
• have a pH that is more than 4.6 and a water activity that is less than 0.85
• have a water activity that is more than 0.85 and a pH that is less than 4.6

Irradiation

The requirements for the irradiation of edible cannabis are:

• edible cannabis can only be irradiated if the edible cannabis product would be one of the following foods (if the product didn't contain cannabis):
• wheat
• flour
• whole wheat flour
• whole or ground spices and
• dehydrated seasoning preparations
• irradiation parameters would need to meet the requirements found in columns 2-5 of the table to Division 26 of Part B of the Food and Drug Regulations

Describe your measures to meet the cannabis-type specific requirements

As applicable to your activity and operations, your preventive control plan should include:

• measures you will take to meet the requirements mentioned above
• documents you will use as evidence of the measures taken

For example, written procedures for the production of edible cannabis that meets the requirements above would include information such as:

• a current written formula that:
• identifies all ingredients and components
• specifies the quantity of each ingredient, including food additives
• includes only food additives that are permitted for use and within the prescribed maximum level of use
• identifies allergens
• procedures and frequencies for verifying that your written procedures are followed
• documents you use as evidence of the measures you take to meet the requirements such as:
• records of analyses that verify the cannabis meets the criteria set out in your standard, for example, pH and water activity
• batch records