Manufacturers participating in the PMAP gain the opportunity to be assessed by a single AO to both US and Canadian regulatory quality management system requirements. It is anticipated that this will reduce audit/inspection-related interruptions in the work place and result in resource savings for manufacturers.
AOs participating in the PMAP have the opportunity to better serve their clients by offering a wider range of services that would allow manufacturers to fulfill both US and Canadian regulatory requirements.
As noted above, FDA and HC hope to use experience gained with the PMAP to identify best practices and to promote an enhanced cooperative regulatory approach.
