Risk Classification of Good Manufacturing Practices (GMP) Observations

In September 2012, Health Canada revised GUI-0023, Risk Classification of GMP Observations to Classify Observations Noted During Establishment Inspections According to their Risk.

The purpose of the guideline is to ensure uniformity among Canada’s Inspectors in the attribution of ratings following establishment inspections and to inform industry of situations that are considered unacceptable and that would generate a Non-Compliant rating following an inspection. Risk is categorized as Critical (Risk 1), Major (Risk 2), and Other (Risk 3). The assignment of a Critical Observation is reserved for high risk products, unless there is evidence during the inspection of fraud, widespread cross contamination, infestation or unsanitary conditions.

Read the documentation here.