Overview: Preventive control plan for cannabis extracts and edible cannabis
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Who is this for
This guide is intended to assist cannabis processing licence holders who conduct activities related to a cannabis extract or edible cannabis in developing, implementing, and maintaining a preventive control plan that meets the requirements of the Cannabis Regulations.
Disclaimer: This guide is intended as supplemental information to the Cannabis Act (the Act) and the Cannabis Regulations (the Regulations). If there are differences between this guide and the Cannabis Act or the Cannabis Regulations, the Act or the Regulations takes precedence. This document is an administrative document that is intended to facilitate compliance by regulated parties with the Act, the Regulations and the applicable administrative policies. This document is not intended to provide legal advice regarding the interpretation or application of the Act or Regulations. If a regulated party has questions about legal obligations or responsibilities under the Act or Regulations, they should seek their own legal advice.
What's a preventive control plan
Processing licence holders who conduct activities related to cannabis extracts or edible cannabis are required to prepare, keep, maintain, and implement a preventive control plan.
A preventive control plan is a written document that demonstrates how hazards to the cannabis, or anything used as an ingredient in the production of your cannabis extract or edible cannabis are identified and prevented, eliminated or reduced to an acceptable level.
You can take many approaches in developing your plan. The design of your plan may vary, depending on the size and complexity of your activities. You should tailor the information in your plan to reflect your specific business and activities. Health Canada does not approve preventive control plans and does not provide preventive control plan templates. You must ensure that your written preventive control plan meets the requirements of the Regulations.
What does it include
Your preventive control plan must include:
- a hazard analysis that describes the biological, chemical, and physical hazards that may be reasonably expected to contaminate the cannabis, or anything used as an ingredient
- descriptions of the control measures for preventing, eliminating or reducing to an acceptable level those hazards, and the evidence showing that they are effective
- descriptions of the critical control points in your process, if applicable, including:
- the related control measures, and the evidence showing that they're effective
- a description of the critical limits for each critical control point
- procedures for monitoring the critical control points in relation to their critical limits
- corrective action procedures for each critical control point
- procedures for verifying that the implementation of the preventive control plan results in compliance with the Regulations
- evidence that you have implemented your preventive control plan
In addition, your plan must include:
- descriptions of the measures you have in place to meet the specific requirements in the Regulations for cannabis extracts or edible cannabis, for example adhering to restrictions on ingredients
- supporting documents used to develop your preventive control plan, such as the information you used to determine your hazards, the rationale for identifying your critical control points, and data to support any critical limits in place throughout your process
If you have questions about the information or requirements for a preventive control plan, you are invited to contact the Controlled Substances and Cannabis Branch at email@example.com.For questions related to Health Canada inspections, you may contact the Regulatory Operations and Enforcement Branch at firstname.lastname@example.org.
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