Under the Cannabis Regulations, anyone who holds a licence for processing (standard or micro) and conducts activities in relation to cannabis extracts or edible cannabis must prepare, retain, maintain and implement a written Preventive Control Plan (PCP) 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.
A Preventive Control Plan is a written document that demonstrates how hazards to your cannabis product are identified, prevented, eliminated or reduced to an acceptable level. The content of your PCP depends on the activities you conduct at your site, and may include elements relating to packaging, labelling, grading, standards of identity, and food safety.
A PCP allows you to identify and describe the biological, chemical and physical hazards associated with the cannabis product (edible or extract), document how you intend to control those hazards, provide the information you used to develop your plan, and demonstrate through records that you have implemented your plan.
When conducting a hazard analysis, all hazards that present a risk of contamination to the cannabis extract and/or edible cannabis must be identified and evaluated, and a determination must be made as to how these hazards will be controlled. Your PCP should be detailed, thorough and should cover the following hazards:
Biological hazards – including microorganisms such as bacteria, viruses, parasites, fungi and molds. Examples of sources of biological hazards may include, but are not limited to:
- Incoming ingredients, including raw materials
- Cross-contamination in the processing or storage environment
- Employees
- Cannabis extract, edible cannabis, and ingredient contact surfaces
- Air
- Water
- Insects and rodents
Chemical hazards – may occur naturally, or may be introduced during any stage of cannabis extract or edible cannabis processing. Examples of chemical hazards may include, but are not limited to:
- Chemicals intentionally used in cannabis extract and edible cannabis processing, such as ingredients, including food and food additives
- Chemicals that are by-products of processing, such as nitrosamines, chloramines
- Chemical contamination from equipment, such as lead-soldered seams
- Industrial chemicals such as cleaning agents, oils, gasoline, lubricants, ammonia
- Naturally occurring toxicants such as products of plant or microbial metabolisms, including mycotoxins or histamines
- Agricultural chemicals such as pesticides, antibiotics, fungicides, rodenticides, algaecides, and fertilizers
- Nutrients, such as over-addition of vitamins and/or minerals
- Food allergens such as peanuts, tree nuts, sesame seeds, milk, eggs, fish, crustaceans, shellfish, soy, mustard and wheat, sources of gluten and sulphites
Physical hazards – including many types of unwanted materials that may be introduced anywhere along the chain, from production through distribution. Unwanted materials can be introduced by anything or anyone coming in contact with the extract cannabis and/or edible cannabis, such as by people who handle the cannabis extract or edible cannabis, or during processing, distribution or storage. The unwanted materials are considered to be hazards if they can result in illness or injury to anyone who consumes the cannabis extract or edible cannabis. Examples of physical hazards include:
- Stones, rocks and dirt
- Metal (commonly associated with processing activities such as milling, 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 food handling practices)
- Glass or other contaminants from packaging materials or containers, or from the processing environment (e.g., uncovered light fixtures)
- Wood splinters from broken pallets or packaging material
- Flaking paint from overhead structures or equipment
- Insect pieces
Licence holders must have procedures for verifying that the implementation of the PCP results in compliance with the Cannabis Regulations. Licence holders must also have supporting documents to substantiate the PCP. Verification procedures and supporting documentation apply, but are not limited to:
- Critical control points and their control measures
- Control measures for hazards not part of a critical control point
- Measures taken to ensure that other regulatory requirements (e.g., labelling, maximum quantity of THC, contaminants) are met
- Monitoring procedures
- Corrective actions procedures
Verification activities are used to confirm and demonstrate that all control measures and procedures outlined in the PCP are consistently implemented and effective in achieving the intended outcome. Every written verification procedure should answer the basic questions: who, when, what, why and how.
Preventive Control Plans require expertise in quality assurance. Therefore, your PCP must be reviewed and acknowledged by your Quality Assurance Person (QAP), who oversees the production processes and can monitor the safety of your product(s). Keep in mind, you must re-evaluate the PCP when there are changes made to any critical parameter at the time of implementation. This can include modifications to the process, components/ingredients, regulatory constraints, preparations, etc.
5 Essential Steps to Creating an Effective Preventive Control Plan:
Identify the risks you need to address:
Before you can create an effective preventive control plan, it’s important to identify what risks your business needs to address. Start by taking time to assess potential hazards and determining which require action. Consider the different areas of your business, such as personnel, property, and processes, and take note of any potential high-risk areas. Once you have identified the risks in each area of your business, prioritize them according to their urgency.
Create a plan for mitigating risks and determining controls:
After you have identified the risks and assessed their likelihood, it’s time to create a plan for mitigating these risks. You should decide on ways to reduce or eliminate them (eradication), to mitigate their impact (prevention), or to minimize damage or other negative outcomes (residual). You should also decide on appropriate control measures such as policies, procedures, training, and monitoring. These controls should be adequately documented so that everyone knows what needs to be done in order to maintain the safety and effectiveness of your preventive control plan.
Establish unique monitoring standards for each risk area:
Your preventive control plan should contain specific monitoring standards that are tailored to each risk area. Standard monitoring can help you identify where systemic weaknesses may exist in your system and, more importantly, enable you to take corrective and preventative actions to reduce the risk associated with those areas. Monitoring’s should be implemented consistently and promptly with appropriate documentation so that all areas of risk have been addressed. Additionally, monitoring should include both qualitative and quantitative methods to ensure an accurate assessment of risk levels.
Develop easy-to-use reporting tools and processes:
Developing clear and timely reporting tools is an essential part of any preventive control plan. Identifying potential areas of risk and documenting related specifications and processes helps increase transparency, enforce compliance, and simplify auditing processes. An easy-to-use template or report can also help ensure accurate documentation and standardization of risk management procedures. Additionally, consider introducing consistent automated reminders for employees when reviews of existing preventive controls are needed to avoid lapses in security procedures.
Monitor progress, track changes, and make adjustments as needed:
Your preventive control plan may need to change over time as conditions in the workplace change. It’s important to stay on top of any changes in preventative measures and implement processes for monitoring progress and tracking changes. You’ll also want to establish a process for responding to problems or issues that arise, either by making necessary adjustments or implementing additional control plans. Additionally, be sure to provide employees with regular updates and timely communication about any changes that occur.
How we can help you
At Cannabis License Experts, we provide you with the guidance to plan your GMP-, GPP- and GACP-compliant business, acquire funding, navigate the legal requirements, and acquire the appropriate licence for your operations. As the Canadian cannabis industry develops, more and more licensed producers will be needed to meet the demands of consumers. Cannabis License Experts offers support from day one of starting your cannabis business, including strategic planning, floor plan preparation, site audits, SOPs, Preventive Control Plans and more. Our Edibles Compliance division can provide you with a solid plan for your edibles business to help get your products on store shelves. Contact us today to discover how we can license and legalize your cannabis business to meet federal or provincial regulations.
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