Don’t let Health Canada inspections catch you off guard. Use this checklist to ensure your cannabis brand is fully prepared!
When it comes to ensuring compliance with Health Canada regulations, a thorough understanding of the Health Canada inspection checklist is crucial. This checklist helps manufacturers, importers, and distributors in the health and wellness industry maintain high standards and remain compliant with Health Canada regulations. Understanding this inspection checklist is essential for ensuring your products meet Health Canada’s strict requirements.
Overview Of Health Canada’s Mandate
Health Canada plays an essential role in regulating products that directly impact the health and safety of the people living in Canada. It is responsible for setting rules and standards for the production, handling, and use of products like cannabis, drugs, controlled substances, pesticides, and tobacco.
The main goal here is to safeguard the general public, ensure the efficacy and safety of these products; ultimately, to safeguard the economy and environment. As part of its remit, Health Canada conducts inspections to verify whether regulated parties comply with the laws and regulations set under the following:
- Cannabis Act
- Food and Drugs Act
- Controlled Drugs and Substances Act
- Pesticide Residue Compensation Act
- Tobacco and Vaping Products Act
Health Canada Inspection Process and Objectives
The inspection process and objectives are straightforward and focused. As regulators, we are here to protect public safety and ensure industry compliance with the law. Our inspectors are designated by the Minister of Health. They work independently and are authorized to conduct inspections of regulated parties to ensure they adhere to the law.
Our inspectors will visit you, the licensed cannabis producer, to do a Health Canada inspection. They will look at your Standard Operating Procedures (SOPs), your recordkeeping, your facility, and the cannabis itself. They will look at every single action required to be documented. Our inspectors will measure the quality of your production and the value of your product to provide producers with a baseline on how well they are doing.
How Health Canada Inspectors Are Designated
Health Canada inspectors are designated by the Minister of Health. They are chosen for the specific expertise they bring to the job. These inspectors are also authorized to conduct inspections on regulated parties to monitor and verify compliance with the laws. The laws that Health Canada enforces are the following:
- Cannabis Act
- The Food and Drugs Act
- The Controlled Drugs and Substances Act
- The Pesticide Residue Compensation Act
- The Tobacco and Vaping Products Act.
To enhance their credibility in enforcing the law, they are given a badge, uniform, and identification card. These identify inspectors as authorized officers.
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1. Produce the best quality products
2. Connect your QA team to the rest of your operations
3. Track Accounts, Orders, and Shipments in one place
4. Capture new markets through high-quality standards
5. Report & capture data in one place.
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The Purpose Of Cannabis Regulations And Inspections
Health Canada conducts inspections to assess your compliance with the Cannabis Act and the Cannabis Regulations. Sections 85 and 86 of the Cannabis Act give Health Canada inspectors the authority to conduct inspections. An inspection may be scheduled or unannounced. It may happen at your licensed site, virtually through video communications, or both.
The purpose of Health Canada’s inspections and audits is to verify that the cannabis producer is compliant with the cannabis act and cannabis regulations. Health Canada auditors will check that your facility (usually every 6 months) is up to Good Production Practices (GPP) and security standards and that the cannabis products you produce are complaint from composition and quality, packaging and labelling and promotions standpoint.
Why It’s Crucial to Inspect the Production Sites for Cannabis Brands
The purpose of Health Canada’s inspections and audits is to verify that the cannabis producer is compliant with the cannabis act and cannabis regulations. Health Canada auditors will check that your facility (usually every 6 months) is up to Good Production Practices (GPP) and security standards and that the cannabis products you produce are complaint from composition and quality, packaging and labelling and promotions standpoint.
Inspections also include confirming that you’re compliant with your license agreement. Preparing for these inspections can be a daunting task, but it’s crucial to ensure your facility is up to code and you’re continually addressing any compliance gaps.
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Different Types Of Inspection That Health Canada Conducts
Regular Inspection
Regular inspections are comprehensive inspections that cover any aspect of the Canadian cannabis regulations but often focus on GPP, product composition, packaging, and labelling. These inspections are conducted for various cannabis license holders, such as:
- Micro-cultivation
- Nursery
- Standard cultivation
- Micro-processing
- Standard processing
- Sale for medical purposes.
Sales Inspection
A sales inspection is triggered when a company submits a sales amendment to Health Canada. The cannabis regulations require a cannabis producer to have a sales amendment, an add-on to a regular license, to sell final packaged cannabis products to consumers in Canada. To receive this license, cannabis producers must submit full batch records for two lots of cannabis per form of cannabis (dried, extract, topical) to Health Canada.
Targeted Inspection
A targeted inspection can be specific to a section within the regulations or related to an observation from a previous inspection report. These inspections are conducted for cannabis license holders of micro-cultivation, nursery, and standard cultivation, as well as micro-processing and standard processing, and sale for medical purposes.
Uncomplicate Your Cannabis Production
It’s easy to slip into a poor state of recordkeeping with every single action required to be documented by Health Canada. The dozens of transactions between production, inventory, quality, and finance must be meticulously recorded in a presentable form for Health Canada. These batch records can be hundreds of pages long.
GrowerIQ is a complete cannabis production management platform. Ours is the first platform to integrate your facility systems, including sensors, building controls, QMS, and ERP, into a single simplified interface. GrowerIQ is changing the way producers use software – transforming a regulatory requirement into a robust platform to learn, analyze, and improve performance.
Our platform helps:
1. Produce the best quality products
2. Connect your QA team to the rest of your operations
3. Track Accounts, Orders, and Shipments in one place
4. Capture new markets through high-quality standards
5. Report & capture data in one place.
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What To Expect From A Health Canada Inspection
Inspectors will check rooms and equipment used for cannabis production, taking pictures and making copies of records. They may also take samples to assess compliance. The requested documentation can include an up-to-date floor plan, master SOP list, inventory list, complaints and adverse events, and more.
How inspections may be planned or unplanned
Health Canada inspections can be planned or unplanned. It’s easy to slip into a poor state of recordkeeping with every single action required to be documented by Health Canada. The dozens of transactions between production, inventory, quality, and finance must be meticulously recorded in a presentable form for Health Canada. These batch records can be hundreds of pages long.
GrowerIQ is a complete cannabis production management platform. Ours is the first platform to integrate your facility systems, including sensors, building controls, QMS, and ERP, into a single simplified interface. GrowerIQ is changing the way producers use software – transforming a regulatory requirement into a robust platform to learn, analyze, and improve performance.
Our platform helps:
1. Produce the best quality products
2. Connect your QA team to the rest of your operations
3. Track Accounts, Orders, and Shipments in one place
4. Capture new markets through high-quality standards
5. Report & capture data in one place.
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Health Canada Inspection Checklist For Cannabis Brands And General Steps To Inspection
The introductory meeting is essential for a Health Canada inspection of a cannabis licensee. Inspectors will contact the responsible person to schedule the meeting and request documents beforehand. This meeting lays the groundwork for successful inspection by clarifying communication and understanding between the licensee and inspectors.
Health Canada Inspection Checklist: Site Tour and Site Verification
The site tour and verification are crucial aspects of a Health Canada inspection. Inspectors ensure compliance with the Cannabis Act and Regulations, examining sanitation, storage, and records. Immediate action is necessary for any non-compliance with regulations identified during the inspection.
Health Canada Inspection Checklist: Record Review
Following the site tour, inspectors may request additional documents to complete their assessment of the regulatory requirements. This record review is a crucial step in ensuring that the licensee’s operations comply with the Cannabis Act and Regulations. By examining the required documents, inspectors can thoroughly evaluate the licensee’s adherence to health and safety standards and identify any areas requiring corrective action.
Health Canada Inspection Checklist: Exit Interview
At the conclusion of the inspection, an exit interview is conducted by inspectors. During this interview, the inspectors will communicate their findings and observations to the licensee. These observations are based on information obtained during the inspection and identify areas where the licensee does not meet the requirements of the Act or Regulations. The licensee will be asked to develop a corrective and preventive action plan based on these observations.
Health Canada Inspection Checklist: Receiving the Inspection Report
After the exit interview, the licensee will receive an inspection report through the Cannabis Tracking and Licensing System (CTLS). This report will link inspection observations to relevant sections of the Cannabis Act or Regulations, provide ratings for each observation, and offer an overall rating for the inspection. Observations will be categorized as minor, major, or critical, and the inspection will receive an overall rating of Compliant or Non-Compliant based on these findings.
Health Canada Inspection Checklist: Responding to the Inspection Report
After receiving the inspection report, the licensee must submit a CAPA plan for each observation within 10 business days. The plan should address all cited observations and propose an implementation date. Inspectors will review the plan and issue a monitoring report if the initial response is inadequate; otherwise, a final monitoring report will conclude the inspection.
Strategies To Prepare For A Successful Health Canada Inspection
Maintaining open communication with Health Canada inspectors is vital throughout the inspection process. Building good relationships can lead to repeat inspections, so transparency during the inspection is key. Inspectors aim to ensure compliance with regulations, emphasizing the importance of transparency in responses.
Cooperation and Transparency: Working with Inspectors to Ensure Regulations are Being Followed
Cooperation with Health Canada inspectors should be a top priority. Demonstrating a commitment to following regulations and maintaining transparency can help establish a positive working relationship with inspectors. During the inspection, it is important to show willingness to answer questions, provide requested documents promptly, and be open to feedback. Compliance with regulations and standards is key for a successful inspection.
Documentation Management: Keeping Your Paperwork in Order
Organizing and keeping track of all required documentation is essential to a successful Health Canada inspection. Make sure that commonly requested documents, such as the Operational Security Plan, Standard Operating Procedure list, inventory list, and floor plan, are up-to-date and readily accessible during the inspection. Having these documents prepared in advance can help streamline the inspection process and demonstrate a commitment to following Health Canada regulations.
Outline Roles and Responsibilities of Team Members: Designating Responsibilities for a Smooth Inspection
Defining the roles and responsibilities of team members is crucial to ensuring that everyone understands their part in preparing for the Health Canada inspection. Each team member should be aware of their responsibilities and be prepared to fulfill them during the inspection. Distributing tasks among team members can help ensure that everything is in order and that the inspection goes smoothly.
Take Corrective Actions: Addressing Observations and Deficiencies Promptly
If any observations or deficiencies are noted during the Health Canada inspection, it is important to address them promptly. Developing corrective action plans for any issues identified can help show inspectors that you are serious about compliance and willing to make improvements where necessary. Taking corrective actions in a timely manner can help prevent future issues and maintain good standing with Health Canada.
Schedule Mock Inspections: Preparing for the Real Deal
Conducting mock inspections, whether internally or externally, can help prepare your team for the real Health Canada inspection. Mock inspections can help identify any potential issues or deficiencies in advance, allowing you to address them before the actual inspection. This can help reduce stress and ensure that your team is well-prepared for the inspection.
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Retrieve Batch Records And Inventory Data In Seconds With GrowerIQ
GrowerIQ is a comprehensive cannabis production management platform designed to simplify the process of recording and tracking every single action required by Health Canada. Our platform integrates various facility systems, including sensors, building controls, Quality Management Systems (QMS), and Enterprise Resource Planning (ERP), into a single, user-friendly interface. By consolidating these systems, GrowerIQ streamlines the management of production workflows and regulatory compliance.
Produce the Best Quality Products
One of the primary aims of GrowerIQ is to help cannabis producers consistently deliver high-quality products. By providing an integrated platform that connects all operational aspects of a facility, including production, inventory, quality, and finance, GrowerIQ ensures that quality standards are met every step of the way.
Connect Your QA Team to Operations
GrowerIQ bridges the gap between Quality Assurance (QA) teams and other operational functions within a cannabis facility. By enabling seamless communication and data sharing between different departments, GrowerIQ ensures that QA protocols are adhered to and that corrective actions can be swiftly implemented whenever necessary.
Track Accounts, Orders, and Shipments in One Place
Managing accounts, orders, and shipments can be challenging in a highly regulated industry like cannabis production. GrowerIQ simplifies this process by providing a centralized platform for tracking and managing all financial transactions, customer orders, and product shipments.
Capture New Markets Through High-Quality Standards
Maintaining high-quality standards is essential for entering new markets, especially those with strict regulations like Health Canada. GrowerIQ’s robust quality control features help producers align their products with the stringent requirements of emerging markets, facilitating market expansion and growth.
Report & Capture Data in One Place
Efficient data reporting and capture are crucial for compliance with Health Canada regulations. GrowerIQ streamlines these processes by consolidating all production data in a single platform, making it easy to generate reports and comply with regulatory requirements.
Discover how GrowerIQ’s seed-to-sale software can help you set up all of the administrative components of a successful cannabis cultivation operation, without any hassle. Questions we haven’t covered? Please reach out and let us know. GrowerIQ serves clients coast to coast, and we’re ready to help your team today.
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