Service Standard for Facility Inspections/Audits

  1. Canadian manufacturers
  2. Canadian importers
  3. U.S. manufacturers of autogenous vaccines or products under the Food and Drug Administration's Export Reform and Enhancement Act
  4. U.S. manufacturers of other veterinary biologicsFootnote 1
  5. Non-Canadian, non-U.S. manufacturers

Performance Target

The targets for achieving the following standards are:

  1. Canadian manufacturers - Annually
  2. Canadian importers – Every three years
  3. U.S. manufacturers of autogenous vaccines or products under the Food and Drug Administration's Export Reform and Enhancement Act - Annually
  4. U.S. manufacturers of other veterinary biologics - See footnoteFootnote 1
  5. Non-Canadian, non-U.S. manufacturers – Every four years

Performance Results

In 2016-17, the Agency:

  1. Conducted 100% of the 7 required audits/inspections of Canadian manufacturers within the service standard.
  2. Audited/inspected 70% of the 27 Canadian importers within the service standard.
  3. Audited/inspected 100% of 1 U.S. manufacturer of autogenous vaccines or products under the Food and Drug Administration's Export Reform and Enhancement Act.
  4. Audited/inspectedFootnote 1 100% of 1 U.S. manufacturer of other veterinary biologics considered a risk within the service standard.
  5. Audited/inspected 100% of 1 non-Canadian or non-U.S. manufacturers considered a risk within the service standard.

In 2015-16, the Agency:

  1. Conducted 100% of the six required audits/inspections of Canadian manufacturers within the service standard.
  2. Audited/inspected 100% of the 16 Canadian importers within the service standard.
  3. Audited/inspected 100% of one U.S. manufacturer of autogenous vaccines or products under the Food and Drug Administration's Export Reform and Enhancement Act.
  4. Did not conductFootnote 2 any audit/inspections of U.S. manufacturers of other veterinary biologicsFootnote 1 considered a risk within the service standard.
  5. Audited/inspected 100% of one Non-Canadian or non-U.S. manufacturers considered a risk within the service standard.

In 2014-15, the Agency:

  1. Conducted 56% of the nine required audits/inspections of Canadian manufacturers within the service standard.
  2. Audited/inspected 37% of the 30 Canadian importers within the service standard.
  3. Did not conductFootnote 2 any audits/inspections of U.S. manufacturers of autogenous vaccines or products under the Food and Drug Administration's Export Reform and Enhancement Act.
  4. Did not conductFootnote 2 any audit/inspections of U.S. manufacturers of other veterinary biologicsFootnote 1 considered a risk within the service standard.
  5. Did not conductFootnote 2 any audit/inspections of non-Canadian or non-U.S. manufacturers considered a risk within the service standard.

In 2013-14, the Agency:

  1. Conducted 100% of the 14 required audits/inspections of Canadian manufacturers within the service standard.
  2. Audited/inspected 100% of the 15 Canadian importers within the service standard.
  3. Did not need toFootnote 3 conduct any audits/inspections of U.S. manufacturers of autogenous vaccines or products under the Food and Drug Administration's Export Reform and Enhancement Act.
  4. Performed 100% of the two audit/inspections of U.S. manufacturers of other veterinary biologics1 considered a risk within the service standard.
  5. Performed 100% of six audit/inspections of Non-Canadian or non-U.S. manufacturers considered a risk within the service standard.

Applying for Facility Inspections/AuditsFootnote 3

Please see Veterinary Biologics Guideline 3.11 - Guideline for Inspection of Veterinary Biologics Manufacturers and Importers.

Service feedback

If you have a service complaint, please complete a Feedback Form or communicate with one of our Contacts.

For more information

To learn about upcoming or ongoing consultations on proposed federal regulations, visit the Canada Gazette and Consulting with Canadians websites.

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