On Tuesday June 23, 2026, at the Pharmaceutical Sciences Group’s (PSG) 9th Annual Day with Health Canada, Karolina Zarichna from Source Nutraceutical, Inc. (SNI) attended discussions on recent Good Manufacturing Practices (GMP) inspection trends and compliance expectations for Canadian and foreign drug establishments.
Health Canada provided insight into inspection observations across the regulated industry, highlighting common compliance challenges identified through domestic and foreign inspections conducted under Division 2 of the Food and Drug Regulations.
While individual companies understand their own quality systems, Health Canada’s inspection program provides a broader view of recurring trends across manufacturers, importers, distributors, wholesalers, packagers, labellers, and testing laboratories.
- What Drug Establishments Does Health Canada Inspect?
- How Have Health Canada GMP Inspections Changed?
- Why Are Foreign GMP Inspections Important for Canada’s Drug Supply?
- What Are the Most Common Health Canada GMP Inspection Observations?
- What Additional GMP Trends Were Seen at Foreign Sites?
- Does a Compliant GMP Rating Mean There Are No Issues?
- What Leads to a Non-Compliant Health Canada Inspection Rating?
- What Does Health Canada Expect from CAPA Responses?
- What GMP Issues Are Common by Site Type?
- How Can Companies Prepare for Future GMP Inspections?
- Preparing for Health Canada GMP Compliance Expectations
What Drug Establishments Does Health Canada Inspect?
Health Canada regulates drug establishments conducting licensable activities under a Drug Establishment Licence (DEL). As of May 2026, Health Canada indicated there were over 900 licensed buildings in Canada subject to GMP oversight.
These sites cover a wide range of products and activities, including:
- Pharmaceutical drugs
- Biologic drugs
- Active pharmaceutical ingredients (APIs)
- Vaccines
- Radiopharmaceuticals
- Veterinary products
Regulated activities include:
- Fabrication
- Packaging and labelling
- Importation
- Distribution
- Wholesaling
- Testing
Each activity carries different compliance risks, which influences Health Canada’s oversight approach.
How Have Health Canada GMP Inspections Changed?
Health Canada reviewed inspection trends over the last decade, highlighting different patterns between domestic and foreign GMP inspections.
Domestic inspection volumes have remained relatively stable over time, supported by established inspection cycles under Health Canada’s risk-based inspection framework.
During the COVID-19 pandemic, Health Canada maintained oversight through alternative approaches, including remote assessments and other alternative oversight approaches. However, Health Canada acknowledged that remote assessments do not fully replace onsite inspections, particularly for higher-risk activities.
Following the pandemic period, domestic GMP inspection activities have returned closer to historical levels.
Why Are Foreign GMP Inspections Important for Canada’s Drug Supply?
Health Canada highlighted the global nature of Canada’s pharmaceutical supply chain.
A significant portion of products supplied to Canadians rely on foreign manufacturing sites, making international cooperation essential.
Health Canada discussed the importance of:
- Mutual Recognition Agreements (MRAs)
- Pharmaceutical Inspection Co-operation Scheme (PIC/S) alignment
- International regulatory collaboration
- Information sharing with trusted regulatory partners
Because direct inspection of every foreign site is not practical, Health Canada relies on strong international partnerships to support oversight while maintaining confidence in product quality.
What Are the Most Common Health Canada GMP Inspection Observations?
A consistent trend identified across both domestic and foreign inspections was the importance of the Quality Control Department requirements under Division 2 of the Food and Drug Regulations.
Health Canada identified quality oversight as one of the most frequently cited GMP areas.
Common quality-related observations include:
- Insufficient quality system oversight
- Weak change control processes
- Inadequate investigation of deviations
- Insufficient handling of out-of-specification results
- Documentation gaps
- Ineffective corrective and preventive actions (CAPAs)
The trend suggests that compliance issues are often not caused by a single event, but by broader weaknesses in the overall quality management system.
What Additional GMP Trends Were Seen at Foreign Sites?
Foreign inspection trends showed similar quality oversight concerns, with additional focus areas depending on manufacturing activities.
Health Canada highlighted increased attention on:
- Sterile product controls
- Aseptic processing expectations
- Sanitation programs
- Contamination prevention strategies
These trends reflect the complexity and higher risk profile associated with certain manufacturing activities, particularly sterile products.
Does a Compliant GMP Rating Mean There Are No Issues?
One important message from Health Canada was that achieving a compliant inspection rating should be considered the minimum expectation. Although most inspected sites receive compliant ratings, many inspections still identify Risk 2 or Risk 3 observations.
Companies should evaluate inspection outcomes beyond the final rating and consider:
- Are observations repeated from previous inspections?
- Do observations suggest systemic quality weaknesses?
- Were previous CAPAs effective?
- Are quality systems keeping pace with operational complexity?
A compliant rating does not eliminate the need for continuous improvement.
What Leads to a Non-Compliant Health Canada Inspection Rating?
Health Canada discussed several common factors that contribute to non-compliant (NC) inspection outcomes.
These include:
- Applying for a DEL before the site is inspection-ready
- Risk 1 observations representing significant compliance concerns
- Multiple Risk 2 observations suggesting broader quality system failures
- Repeat observations showing previous corrective actions were ineffective
A key reminder for industry was that once a DEL application is submitted, an inspection may occur at any time. Companies should ensure their systems are ready before filing.
What Does Health Canada Expect from CAPA Responses?
CAPA plans remain a critical component of inspection response.
Health Canada highlighted that strong CAPAs typically include:
- A clearly identified root cause
- An appropriate root cause analysis methodology
- Specific corrective actions
- Defined ownership and timelines
- Risk-based prioritization
- Effectiveness checks
- Complete documentation
Weak CAPAs often address the immediate issue without correcting the underlying system failure.
A successful CAPA should demonstrate not only what was corrected, but why the issue occurred and how recurrence will be prevented.
What GMP Issues Are Common by Site Type?
Fabricators
Common observations include:
- Quality system weaknesses
- Manufacturing controls
- Equipment controls
- Sanitation deficiencies
Health Canada noted that issues may reflect quality systems that have not scaled appropriately with operational needs.
Testing Laboratories
Common observations include:
- Laboratory data review concerns
- Out-of-specification investigations
- Equipment qualification gaps
- Computerized system validation concerns
- Data integrity risks
As laboratory operations become increasingly digital, Health Canada continues to emphasize data integrity principles, including appropriate controls over electronic records, audit trails, user access management, and computerized systems. These controls help ensure that laboratory data remain complete, accurate, attributable, and reliable throughout the data lifecycle.
Importers, Distributors, and Wholesalers
Common observations include:
- Supplier qualification gaps
- Import oversight issues
- Storage and transportation controls
- Temperature management concerns
For certain imported products, Health Canada highlighted the importance of understanding testing and oversight obligations, including additional oversight expectations were acceptable GMP evidence or applicable recognition arrangements are not available.
How Can Companies Prepare for Future GMP Inspections?
Health Canada’s inspection trends reinforce the importance of maintaining proactive quality systems.
Companies should focus on:
- Strengthening quality oversight
- Ensuring CAPAs address true root causes
- Monitoring repeat observations
- Maintaining inspection readiness
- Investing in appropriate quality resources
- Ensuring documentation reflects actual practices
Preparing for Health Canada GMP Compliance Expectations
Health Canada’s inspection trends show that the future of GMP compliance is moving beyond simply achieving a compliant rating. Regulators are increasingly focused on robust quality systems, effective management oversight, and the ability of companies to identify and correct issues before they impact product quality.
SNI’s DEL GMP Services & Support
SNI supports pharmaceutical and life sciences companies navigating DEL requirements, GMP compliance strategy, Health Canada inspection preparation, quality system development, CAPA management, and lifecycle compliance.
For companies preparing for Health Canada inspections, one of the most common challenges is knowing whether internal systems are truly inspection ready. SNI helps identify compliance gaps before inspection, strengthen quality documentation, and build sustainable systems that align with Health Canada expectations.
Reach out to our team to learn more about how we can support your compliance journey and strategically aligned market entry.
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