The EMA and FDA are seeking pharma manufacturers to participate in a joint GMP (good manufacturing practice) inspection pilot program.
Applicants to the program will ultimately be able to have their manufacturing facilities jointly inspected by both agencies during a single visit -- after both agencies first establish some common rules of engagement. Companies seeking routine re-inspection of their facilities by both agencies aroudn the same time can also apply to this program.
This seems to be -- dare I say it - innovative, common sense solution to saving resources for both the agencies and the customer to be inspected. It reminds me of the Audit Sharing Program that Rx-360 announced earlier this year geared toward sharing audit reports of raw material vendors to all Rx-360 members in the pilot program -- again saving redundant audit time and effort.