Regulatory Focus™ > News Articles > Health Canada Releases New GMP Inspection Guidance

Health Canada Releases New GMP Inspection Guidance

Posted 13 September 2012 | By Alexander Gaffney, RAC 

New guidance released on 11 September by Health Canada makes changes to the way the agency classifies observations made during the course of a good manufacturing practice (GMP) inspection.

The new system is intended to ensure uniformity between various regulatory agencies in Canada, the guidance explains. Inspection findings are at a high level segregated into one of two categories: compliant or noncompliant with the Food and Drugs Act.

As is the case in other countries, "Attribution of a non-compliant rating may have serious consequences for a company," explains Health Canada in the guidance, "ranging from the implementation of important corrective measures to the temporary suspension or termination of the Establishment License (EL)."

But not all instances of non-compliance are created the same. Some may indicate only a minor deficiency, while others may indicate severe and systemic problems that could ultimately place patient safety at risk. Classifying these risk categories can be both subjective and inconsistent, and Health Canada's guidance aims to provide a measure of consistency for both regulators and the industries they regulate.

Inspection Principles: Severity, Extent and Risk to Patients

Health Canada establishes two principles it says should guide its risk classification procedures:

  • Classification should be based on the severity and number of deviations from GMP principles; and
  • Classification should be based on the types of products involved and the level of risk they pose to patients.

Low-level deviations are generally tagged with a "Risk 1" classification, while "Risk 2" is given to companies without sufficient control over their processes or operations, and represents a "major observation."

"Risk 3" is reserved for general observations, which could include inadequate bathroom facilities for staff, unidentified outlets for liquids and gasses, general damage to surfaces not related to or near productions processes, or unsecured doors.

Those classified with a "Risk 1" rating may be able to receive a "compliant" rating if they are able to immediately fix the deficiency or provide, "Sufficient assurance… to prevent a recurrence," Health Canada said.

The guidance comes into effect immediately, replacing a preceding 2003 guidance of the same name.


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