Health Canada releases risk classification guide for drug GMP observations

Health Canada has released a risk classification guide that aims to clarify the manufacturing site inspection process for drug manufacturers. The new guidance for good manufacturing practice (GMP) provides information to ensure a uniform approach that inspectors will use to assign one of three different risk classifications to each noncompliance observation noted during inspections of drug manufacturing facilities. The risk classifications are as follows: critical observation (Risk 1), major observation (Risk 2) or other observation (Risk 3).

Health Canada inspects establishments to assess their compliance with the Food and Drugs Act and associated regulations. When an inspection is carried out, this document will guide how inspectors assign risk to the observations noted during the drug establishment inspection. This guide is for people who work with drugs as fabricators, packagers, labellers, testers, distributors, importers and wholesalers.

During inspections, any situations that may present immediate or impending health risks and/or involve fraud, misrepresentations or process falsification would be placed under the category of critical observations. Any situations that indicate potential production inconsistencies with drug marketing authorisations are major observations. In addition, all other observations are minor GMP nonconformities. According to the guidance document, which provides examples of non-conformance cases for each level, Risk 2 and 3 observations can be upgraded to Risk 1 or 2, respectively.

The new guidance also states the process that is used for inspectors’ overall inspection ratings based on the risks associated with observations.

The document aims to ensure consistency among Health Canada inspectors during drug establishment inspections when classifying good manufacturing practice (GMP) observations according to risk and assigning an overall compliance rating to an inspection or to the paper review of GMP evidence. Furthermore, the guidance informs industry of the situations Health Canada considers unacceptable, which may result in a non-compliant rating and/or compliance and enforcement actions.

To read the risk classification guide for drug GMP observations, please click here.