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Health Canada Spells Out Risk Ratings for GMPs in Site Inspections
Drugs Inspections and Audits
Health Canada issued an updated risk classification guide to ensure consistent decisions by agency inspectors when classifying GMP observations by risk and assigning overall compliance ratings to an inspection.
The guide updates the agency’s 2012 guidance with more examples of critical (Risk 1), major (Risk 2), and other observations (Risk 3), based on new GMP requirements for drug products that go into effect on Oct. 1.
When determining risk classifications, inspectors consider the nature of the product, the nature of the deviation and the number of occurrences, and all observations require corrective action regardless of their magnitude, the guidance says.