• Manoj Swaminathan

Health Canada - Pharmacovigilance inspections are different!

Updated: Aug 10

Health Canada (HC) is one of those authorities which has set its expectations with regards to GVP inspections clearly and there is a lot of information available on the HC website to substantiate this.


Did you know that HC has a dedicated website for GVP inspections, where one can find information on the Pharma entities that have undergone inspection, along with the details pertaining to the observations?


https://www.drug-inspections.canada.ca/gvp/index-en.html



One can even assume that the information is updated on a realtime basis. Try visiting the above site and search using hypothetical dates. Else, try searching with a company name.



What do GVP Inspectors look for?


Inspectors review the drug establishment's records and procedures to assess compliance, including processes for:


Receiving, analyzing, submitting and maintaining records about:

  • ADRs

  • Unusual failures in the effectiveness of new drugs

  • Preparing annual summary reports and issue-related summary reports

Categorization of Observations:


- Critical

- Major

- Minor


Inspection Rating - Compliant or Non-Compliant


Compliant rating

A compliant rating means the establishment is complying with the Food and Drugs Act and associated regulations with respect to GVP. An establishment may receive a compliant rating even if a number of observations have been identified. This is because the rating also takes into consideration the level of risk. Establishments will need to take corrective actions to address any observations.


Non-compliant rating

A non-compliant rating could mean that the establishment has not shown that its activities comply with the Food and Drugs Act and Food and Drug Regulations, or will need to take immediate corrective actions, or the safety information is missing which could lead to serious health risks for Canadians.



Here are additional resources pertaining to HC GVP Inspections:

Good Pharmacovigilance Practices (GVP) Guidelines (GUI-0102)Inspection Strategy for Good Pharmacovigilance Practices (GVP) for Drugs (POL-0041)Risk Classification of Good Pharmacovigilance Practices (GVP) Observations (GUI-0063)


https://www.canada.ca/en/health-canada/services/inspecting-monitoring-drug-health-products/drug-health-product-inspections/about-good-pharmacovigilance-practices-gvp-inspections.html