Phase 1
Pre-Inspection Preparation
1Maintain continuous GMP compliance
Site maintained in ongoing compliance with Food and Drug Regulations Division 2 and GUI-0001 expectations, not prepared reactively upon notice.
GUI-0001
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2Confirm inspection notification and scope
Notification, when provided, reviewed to confirm the expected scope, duration, and areas of the establishment the inspection will cover.
Health Canada Inspection Policy
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3Verify inspector identification and authority
Identification and authority of the Health Canada inspector confirmed before the inspection proceeds.
Food and Drugs Act
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4Assemble the inspection response team
Front-facing hosts and subject matter experts assembled, aligned to the Establishment Licence activities within scope.
Internal SOP
Phase 2
Inspection Opening and Conduct
5Conduct opening meeting
Establishment Licence activities, scope, and expected duration of the inspection confirmed with site leadership at the outset.
Health Canada Inspection Policy
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6Facilitate facility tour and record review
Inspector conducts a facility walkthrough and reviews quality system records, batch documentation, and validation files as requested.
GUI-0001
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7Log observations as they are raised
Every observation raised during the walkthrough or record review logged internally in real time, alongside the site's response.
Internal SOP
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Does the inspector identify a GMP observation?
YES → Classify by risk level
NO → Continue facility review
Phase 3
Observation Risk Classification and Close-Out
8Classify each observation by risk level
Observation classified as Risk 1, Risk 2, or Risk 3 per the criteria defined in GUI-0023, based on actual or potential impact on product quality.
GUI-0023
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9Conduct the exit interview
Final discussion held to review all observations identified, with the site given an opportunity to respond before the inspector departs.
Health Canada Inspection Policy
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10Receive the Exit Notification and report
Formal Exit Notification and subsequent inspection report issued, listing observations with their risk classification and response timeline.
Health Canada Inspection Policy
Phase 4
Response and Compliance Rating Outcome
11Submit the corrective action plan
Written corrective action plan submitted within the timeline specified, addressing root cause for each classified observation.
Health Canada Inspection Policy
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12Implement and verify corrective actions
Committed actions implemented on schedule, with effectiveness verified before the response is considered acceptable to Health Canada.
GUI-0001
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13Receive compliance rating and licence outcome
Overall compliance rating assigned, with implications for the site's Establishment Licence status ranging from compliant to non-compliant.
Food and Drugs Act
Inspection Types (Overview)
Routine / Compliance
Periodic inspection under Health Canada's risk-based inspection cycle, covering the establishment's licensed activities broadly.
Health Canada Inspection Policy
For-Cause
Triggered by a specific concern such as a complaint, recall, or referral, with a scope focused on the triggering issue.
Health Canada Inspection Policy
Pre-Licensing
Verifies a site can operate as described before Health Canada issues a new or amended Establishment Licence.
Food and Drugs Act
Observation Risk Classification (Overview)
Risk 1 (Critical)
A practice or process that has produced, or is likely to produce, a product that poses a serious health risk.
Risk 2 (Major)
A practice or process that has produced, or may produce, a product that does not meet its required quality standards.
Risk 3 (Other)
A practice or process that departs from GMP but does not meet the criteria for a Risk 1 or Risk 2 classification.
Classification drives the rating
The number and severity of Risk 1, 2, and 3 observations determines the establishment's overall compliance rating.
Key Inspection Outputs (Overview)
Exit Notification
Document provided at the end of the inspection summarizing observations discussed during the exit interview.
Inspection report
Formal report listing every observation, its risk classification, and the required corrective action plan timeline.
Compliance rating
Overall rating assigned to the establishment based on the number and severity of observations identified.
Establishment Licence status
Licence maintained, amended, suspended, or cancelled depending on the compliance rating and response to observations.