Heads Up! New and Stricter Health Canada Risk Classification of Drug GMP Observations

Health Canada has updated their guidance document on classifying the observations noted during establishment inspections according to their risk. The format of the document has changed and the observations are getting stricter, but firstly, here are some things that remained constant:

  • Critical observation (i.e. Risk 1) describes a situation that is likely to result in a non-compliance (NC) product or a situation that may result in an immediate or latent health risk and any observation that involves fraud, misrepresentation or falsification of products or data.
  • Major observation (i.e. Risk 2) are those that may result in the production of a drug not consistently meeting its marketing authorization.
  • Minor/Other observation (i.e. Risk 3) are those that are neither critical nor major but is a departure from the GMPs.
  • GMP section Samples C.02.025 – C.02.026 is unaffected by the new guidance.

This guidance document suggests Health Canada will be implementing stricter observations than what was previously expected for GMP deviations. Many observations that were Risk 2 observations have been boosted to Risk 2 (↑) and several Risk 3 observations moved to Risk 2. For example, under Packaging Material Testing (C.02.016, C.02.017), inadequate specifications used to be considered a Risk 3 observation, but is now considered a Risk 2.

Now that industry is aware of current Health Canada thinking, this should help significantly with audit preparation and ensuring proper compliance with GMPs.

What to Do:

  • For a more detailed breakdown of the changes in Health Canada Risk Classification of Drug GMP Observations, please contact FPR
  • The new risk classification of GMP observations guidelines are much stricter than before; hence, remember the importance of following GMP’s to ensure consistent quality of products and protection of consumers

Contact us at 905-271-2709 to learn more about the implications of the new Risk Classification of Drug GMP Observations guidance