When it comes to audits related to Health Canada requirements, staying compliant is about more than checking off a list. It helps you maintain your licence, protect your brand, and stay competitive in a regulated market. If you hold a Drug Establishment Licence (DEL), Medical Device Establishment Licence (MDEL), or a Natural Health Product (NHP) site licence, understanding how audits work can save you from costly compliance issues.
At the same time, internal compliance efforts matter, but they may not catch everything. If you’re unsure whether your systems meet current expectations, you’re not alone. Keep reading to learn how audits can help uncover hidden risks and give you a clearer picture of where your compliance stands.
Why internal audits might fall short
Even the most dedicated internal teams can develop blind spots. For example, familiarity with routine operations may lead to oversights, especially in complex areas like documentation, traceability, and preventive controls. Without specialized training and ongoing exposure to regulatory updates, internal audits may miss key deficiencies.
On the other hand, external audits provide fresh perspective. They focus on critical areas like validation, standard operating procedures (SOPs), CAPA systems, and recordkeeping. As a result, these reviews serve as a proactive tool to uncover non-compliances before Health Canada inspectors arrive.
What Health Canada looks for
To enforce GMP requirements, Health Canada conducts inspections under regulations that apply to drugs, medical devices, and natural health products, which are outlined in documents such as the Good Manufacturing Practices (GMP) Guidelines and Inspection Tracker. During these inspections, inspectors typically assess areas such as:
- Quality management systems and documentation
- Personnel training and hygiene
- Equipment cleaning and maintenance
- Material handling and storage
- Production controls and batch records
- Complaint handling and product recalls
If gaps are found, the outcome can range from observations to more serious enforcement measures, including licence suspension. Regular audits can help confirm your readiness for inspections and avoid reactive compliance fixes.
How the audit process works
A proper compliance audit includes a full review of your facility, procedures, and documentation. It typically begins with a pre-audit questionnaire, followed by an on-site visit and staff interviews. The auditor then issues a detailed report outlining any non-conformances, risk level, and recommended corrective actions.
The audit findings are usually grouped into categories based on severity, and your team is expected to implement a corrective action plan within a reasonable timeframe. Some companies choose to conduct these audits annually or ahead of licence renewals to stay on top of Health Canada expectations.
Frequently asked questions
Do I need an audit if I already passed an inspection?
Yes. Compliance is ongoing. Health Canada inspections are periodic, but requirements must be met at all times. Regulatory expectations evolve, and internal processes may shift over time, so audits are valuable tools to continuously verify that your operations remain aligned with current standards.
What if I find issues during the audit?
Finding issues is not a failure, it’s a benefit of the audit. The purpose of an audit is to uncover gaps before they escalate into compliance problems. Early detection enables your team to correct deficiencies proactively, minimizing the risk of receiving observations or sanctions during a formal Health Canada inspection.
Are audits only for large companies?
No. Audits are useful for businesses of any size. Smaller teams often benefit from extra support, and larger companies use audits to confirm internal controls and stay compliant as they grow.
Can audits help during licence renewal?
Yes. Audits are often used as a preparation step ahead of licence renewals to ensure all documentation and processes meet current standards.
How often should we schedule a compliance audit?
Many businesses schedule audits annually, or before a major change such as licence renewal, product launch, or a Health Canada inspection.
Next steps for your audit
A professional audit helps you stay compliant, protect your licence, and reduce regulatory risk. It’s a proactive investment that strengthens your quality systems and positions your company for long-term success.
That’s why, at Quality Smart Solutions, we support companies of all sizes with tailored audit solutions across the natural health product, drug, and medical device sectors. Our experienced auditors perform in-depth reviews of your operations, identify gaps based on current Health Canada requirements, and deliver actionable plans to help you implement corrective measures efficiently.
We also stay up to date on evolving regulatory trends to help your business stay ahead of compliance challenges. Therefore, if you’re preparing for a Health Canada inspection or want to assess your current compliance status, we can help you take the next step. Book a free consultation with our experts.
