Health Canada Clarifies Risk Classification Process in Drug Manufacturing Site Inspections

Health Canada has published a risk classification guide to clarify the process of inspecting manufacturing sites for drug manufacturers.

The new Good Manufacturing Practices Guide (GMP) provides information to ensure consistency in the approach used by inspectors to categorize one of the three risk categories: critical observation (risk 1), major observation (risk 2) or other observation (risk 3) for each observation of non-compliance found during the inspections of the drug manufacturing facilities.

Situations identified during inspections that may present immediate or imminent health risks, and / or involve fraud, misrepresentation or falsification of processes, would fall into the category of critical observations. Those that indicate possible production inconsistencies with the marketing authorizations of medicines are important observations. All other observations are minor GMP nonconformities.

However, observations on risks 2 and 3 can be improved in risk 1 or 2, according to the 30-page guidance document, which provides examples of non-compliance for each level.

The guidelines also describe the process used for the inspector's general inspection qualifications based on the risks associated with the observations.

"It is impossible to predict all situations that could create a risk," but inspectors generally follow a two-step process: assign a risk based on the nature of the product evaluated and the non-compliance, as well as the number of differences; and seek immediate corrective action when a risk 1, or risk 2 reassessed as risk 1, is in question, according to Health Canada. "If a company wishes to challenge the results of the final score inspection report, the dispute methods will be described in the letter accompanying the final exit notices without qualification," the regulator added.