6 Tips to Ace Your Health Canada Audit
The key to a confident and successful audit is preparation, preparation, and more preparation. My Six Tips will assist you in being prepared and staying confident during a Health Canada (HC) Inspection.
Licensed producers must have previously been fearful or anxious about an approaching Health Canada inspection. The concerns are mostly because an auditor’s non-compliance report may jeopardize all they have worked so hard for, including obtaining their license and building their business plans.
Now, you don’t have to worry because we are here to help you.
Below are the six tips you can adapt to ace your next HC inspection:
the Inspection’s Purpose
1. Understand the Inspection’s Purpose
Understanding the audit’s goal enables you to be appropriately prepared and significantly reduce stress before and after the inspection. This can be accomplished through comprehending why, what, and how Health Canada inspects.
Why is an audit performed?
Inspections are done to uncover any problems that could jeopardize Canadians’ health and safety. The inspection operations are part of a broader effort to ensure that applicable laws and regulations are being followed.
Through a number of compliance and enforcement initiatives, Health Canada manages cannabis-related hazards to public health and safety. Health Canada inspects a Cannabis licensed facility to ensure that the Cannabis Act and Cannabis Regulations are being followed.
- Protect public health and safety
- Reduce illegal cannabis activities
- Provide access to a quality-controlled supply of cannabis.
What & How is the audit is conducted
Knowing what they will inspect and how they will inspect will help you anticipate what to expect during an inspection and ensure that there are no surprises.
- visually examining a facility, inventories, equipment, packaging, labeling and websites
- collecting and reviewing documents and records
- taking samples for laboratory analysis
2. Stay informed with all Current ApplicableRegulations
Ascertain that you have a thorough understanding of all applicable regulations and the competence necessary to comply with them. It is not sufficient to comply with the Cannabis Act and Legislation alone; Health Canada wants licensed producers to also comply with all other applicable Canadian regulations. Additionally, stay updated on any regulatory changes, as HC inspects for conformity with the latest version of regulations.
3. Demonstrate Compliance with the Cannabis
The Cannabis Act and its Regulations are the major regulations that apply to Cannabis businesses. Compliance with all applicable parts of the regulation is required.
Following are some of the major aspects that must be adhered to:
- Good Production Practice (GPP)
- Physical Security
- Packaging and labeling
- Record Keeping/ Inventory Management
If you work in a regulated environment, proper documentation and document control are essential. Prepare the necessary Standard Operating Procedures (SOPs) for all procedures currently in use. During the inspection, you must demonstrate that you follow through on your promises; in other words, you do what you say.
Document control is also crucial; make sure you have a system in place for all documents that include the following:
- Change tracking
5. Perform Mock Inspection/ Internal Audit
The best method to prepare for a regulatory inspection is to conduct your own, which is known as a self-inspection or internal audit. Self-inspection is the most effective method for identifying and rectifying known and undiscovered non-compliance with the process, technique, equipment, storage conditions, and other factors.
If done correctly, though, you can get the full advantage of a mock inspection. It is critical that the audit is led by a qualified person with expertise and experience. In addition, the audit team should include a subject matter expert (SME).
It is advised that an internal audit be performed by a third-party expert
6. Know your Rights and Responsibilities
During and After an Inspection
Rights of Regulated Parties
Regulated parties have the right to:
- Require that Health Canada inspectors identify themselves and explain why they are contacting the regulated party
- Discuss their rights and responsibilities with the inspector
- Ask questions or ask for clarification on any aspect of the inspection process or the laws that apply to them
- Be advised of the results of the inspection, including any reasons for an inspector’s decisions
- Communicate with and receive information in either official language (English or French), as set out by the Official Languages Act
- Obtain information under the provisions of the Access to Information Act
- Have any personal information protected, as set out by the Privacy Act.
hope these 6 Tips to Ace Your Health are very helpful
Responsibilities of Regulated Parties
Regulated parties are expected to:
- Understand the law as it applies to them (i.e., know your legal obligations)
- Ensure their products, activities, and processes comply with applicable laws
- Treat Health Canada inspectors in a courteous and respectful manner
- Give the inspector assistance and provide the inspector with any information requested
- Be prepared to be inspected at any reasonable time.
Regulatory inspections are required and cannot be avoided under any circumstances. So why not plan ahead and ace it. The only important point I want to convey is to concentrate more on what Health Canada’s goal is and their goal is to :
• Protect public health and safety
• Reduce illegal cannabis activities,
• Provide access to a quality-controlled supply of cannabis.
Prepare your processes and procedures to meet HC’s objectives. It’s also a good idea to develop a standard operating procedure (SOP) for regulatory inspection.
How we can Help
We can help you with all aspects of pre and post-HC audits.
- We can perform a mock audit of your facility and let you know your non-conformances and provide you with appropriate corrective action.
- Provide you with compliant documentation and train your staff.
- Train your staff for an HC Audit.
- We also provide customized packages as per your need.
Written By: Mussarat Fatima
President at MF License & Regulatory
Mussarat Fatima, President, and owner of MF Cannabis License and Regulatory Consultants have more than twenty years of experience in Quality Assurance, Quality Control, and Regulatory Affairs within the pharmaceutical, Food, and Cannabis industries. She has a Master’s Degree in Food Sciences and Biochemistry; in addition to this, she also has a diploma in pharmaceutical Quality Assurance, Regulatory Affairs, and Quality Control. Also, she has completed several certifications specifically in Cannabis Quality Assurance, Regulatory Affairs, and Facility management from recognized institutes in Canada.