FDA Answers Questions on Third-Party Inspection Program

http://www.fdanews.com/newsletter/article?issueId=10260&articleId=94117
The FDA recently released a list of questions and answers for device manufacturers interested in the Pilot Multipurpose Audit Program (PMAP), a joint effort by the FDA and Health Canada toward a third-party inspection system satisfying both agencies’ requirements.
Under the PMAP, the two agencies will evaluate the effectiveness of third-party inspections that would meet the regulatory requirements of both Canada and the U.S. The agencies anticipate this will reduce inspection-related manufacturing interruptions and result in cost savings for devicemakers.
“Although the inspections/audits would still encompass two separate but similar sets of requirements, we believe the downtime for a manufacturer will be minimized as a result of one auditing organization conducting the inspections/audits simultaneously,” a 2005 FDA letter to manufacturers said.