FDA, EU consider joint inspections program

4/1/2008

WASHINGTON A pilot program is under discussion between the Food and Drug Administration and the European Union with the intent of using one auditor to conduct facility inspections on behalf of both jurisdictions.

The FDA, in order to facilitate such inspections, recently released a final Global Harmonization Task Force guidance on audit reports prepared on behalf of regulatory agencies.

The FDA and Health Canada currently have a similar arrangement, Pilot MultiPurpose Audit Program, in which a third-party auditor inspects a facility on behalf of both. “We have this pilot program in Canada where it’s one auditor doing [International Standards Organization] and quality system audits at the same time,” said Tim Ulatowski, Center for Devices and Radiological Health director of compliance, according to published reports. “We’ve had a number of successful audits right now that have occurred [and now] the EU wants to join in that pilot.”

The FDA guidance document, “Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers – Part 3: Regulatory Audit Reports,” is intended to promote uniformity and assist auditors in the preparation of more universal reports.

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