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.
What is a Preventive Control Plan?
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.
They play a significant role in ensuring the safety and quality of cannabis products for both medical and recreational use. These plans are designed to identify and mitigate potential hazards and risks at various stages of production, processing, packaging, and distribution. Here’s why PCPs are important in the cannabis industry:
Consumer Safety: The primary goal of a PCP is to protect consumers’ health and safety by preventing contamination, adulteration, and other hazards that could arise during cultivation, processing, and distribution of cannabis products. Ensuring that products are free from harmful substances and pathogens is of utmost importance in a regulated industry.
Regulatory Compliance: Health authorities, such as Health Canada in Canada or other regulatory bodies in different countries, mandate the implementation of PCPs for licensed cannabis producers and processors. Adhering to PCPs is essential for obtaining and maintaining licenses, ensuring compliance with legal requirements, and avoiding penalties or legal consequences.
Quality Assurance: PCPs establish rigorous quality control measures that help maintain consistent product quality and potency. This is crucial for building consumer trust and loyalty, as well as establishing a reputable brand within the industry.
Risk Mitigation: By identifying potential hazards and implementing controls to prevent them, PCPs reduce the risk of product recalls, adverse health effects, and legal liabilities. This proactive approach minimizes the potential negative impact on a business’s reputation and financial well-being.
Documentation and Accountability: PCPs require detailed record-keeping and documentation of all processes, procedures, and quality control measures. This documentation not only ensures transparency but also helps producers and processors trace the source of any issues that may arise and take corrective actions promptly.
Continuous Improvement: Implementing a PCP involves ongoing monitoring and assessment of processes to identify areas for improvement. This focus on continuous improvement helps companies refine their practices, optimize efficiency, and enhance product safety and quality.
Supply Chain Management: PCPs extend to the entire supply chain, from cultivation to distribution. This ensures that all parties involved in the production and distribution of cannabis products adhere to consistent standards, reducing the risk of contamination or hazards at any point along the supply chain.
Public Perception and Industry Reputation: As the cannabis industry continues to evolve, consumer expectations for safe, reliable, and high-quality products increase. Implementing robust PCPs demonstrates a commitment to consumer safety and responsible business practices, contributing to a positive industry image.
In summary, Preventive Control Plans are essential tools for ensuring the safety, quality, and regulatory compliance of cannabis products. They provide a structured framework for identifying, preventing, and managing risks, helping businesses thrive in a competitive and evolving industry while safeguarding consumer well-being.
Preventive control plans play a pivotal role in the cannabis industry for several compelling reasons:
1. Ensuring Consumer Safety: Cannabis products are consumed by individuals for both medical and recreational purposes. Establishing preventive control plans is essential to mitigate potential risks and contaminants that could harm consumers. By identifying hazards and implementing preventive measures, these plans help guarantee the safety and well-being of cannabis users.
2. Regulatory Compliance: The cannabis industry is subject to evolving regulations and standards. Preventive control plans demonstrate a commitment to complying with these regulations, which are in place to safeguard public health and ensure the quality of cannabis products. Failing to adhere to these regulations could result in legal penalties, recalls, and damage to a company’s reputation.
3. Reputation Management: Consumer trust is paramount in the cannabis industry. Preventive control plans demonstrate a commitment to producing safe and high-quality products. This proactive approach can help build and maintain a positive reputation, leading to customer loyalty and continued business growth.
4. Risk Mitigation: Cannabis cultivation, processing, and distribution involve numerous variables that could contribute to potential hazards, including contamination, improper labeling, and incorrect dosing. Preventive control plans help identify these risks and provide strategies to mitigate them, reducing the likelihood of adverse incidents and associated liabilities.
5. Product Consistency: Consumers expect consistency when it comes to the potency, quality, and safety of cannabis products. Preventive control plans establish standardized procedures that ensure consistency in production, leading to reliable and predictable product outcomes.
6. Quality Assurance: Quality is a crucial factor in the cannabis industry. Preventive control plans focus on maintaining quality throughout the production process. This includes proper storage, handling, and processing techniques that prevent degradation and maintain the overall quality of the product.
7. Supply Chain Management: Preventive control plans extend beyond a company’s operations to its supply chain. Collaborating with suppliers who adhere to similar control measures helps ensure the integrity of raw materials and ingredients, contributing to the overall safety and quality of the final product.
8. Business Sustainability: Implementing preventive control plans demonstrates a commitment to long-term business sustainability. By preventing costly recalls, legal battles, and negative publicity, companies can maintain their operations and continue to thrive in the competitive cannabis market.
In essence, preventive control plans are crucial in the cannabis industry to protect consumers, adhere to regulations, maintain reputation, minimize risks, ensure consistent product quality, manage the supply chain effectively, and establish a strong foundation for business growth.
What can be done with a Preventive Control Plan?
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.
What hazard controls should be detailed in your PCP?
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
- Cannabis extract, edible cannabis, and ingredient contact surfaces
- 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
Do license holders need to have procedures for verifying or implementing their PCP?
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.