FDA, Health Canada to Continue Joint Third-Party Inspections

Giving devicemakers two inspections for the price of one, the FDA and Health Canada (HC) have agreed to move forward with a joint third-party inspection program.

The decision follows the conclusion of the agencies’ pilot Multipurpose Audit Program. The pilot allowed qualified accredited persons and auditing organizations, operating under the FDA’s Accredited Persons (AP) for Inspections program and HC’s Third-Party Auditing Organizations, to conduct a single audit that would satisfy both agencies.

To facilitate joint audits in the future, a single audit report format should be adopted, the FDA and HC recommend. Benefits of a permanent joint program include “the reduction of regulatory burden on industry, better use of FDA and HC resources and increased service by APs to their clients,” the agencies say.
The GMP Letter