Health Canada Clarifies Risk Classification Process in Drug Manufacturing Site Inspections
Health Canada has released a risk classification guide aimed at clarifying the manufacturing site inspection process for drugmakers.The new guideline for good manufacturing practices (GMP) provides information for ensuring uniformity in the approach inspectors will use to assign one of three different risk classifications – critical observation (Risk 1), major observation (Risk 2) or other observation (Risk 3) – to each noncompliance observation noted during inspections of drug manufacturing facilities.
Situations identified during inspections that may present immediate or impending health risks, and/or involve fraud, misrepresentations or process falsification would fall under the category of critical observations. Those that indicate potential production inconsistencies with drug marketing authorizations are major observations. All other observations are minor GMP nonconformities.
Risk 2 and 3 observations, however, can be upgraded to Risk 1 or 2, respectively, according to the 30-page guidance document, which provides some examples of nonconformance cases for each level.
The guidance also describes the process used for inspectors’ overall inspection ratings based on the risks associated with observations.
“It’s impossible to foresee every situation that may generate a risk” but inspectors will generally follow a 2-part process: assign risk depending on the nature of the evaluated product and the nonconformity, as well as the number of deviation occurrences; and request immediate corrective action when a Risk 1, or a Risk 2 re-evaluated as a Risk 1, is involved, Health Canada said. “If a company wants to dispute the results of the inspection report of the final rating, methods of dispute will be outlined in the letter accompanying the unrated and final exit notices,” the regulator added.
Health Canada