EMA, FDA seek applicants for joint GMP inspections

EMA, FDA seek applicants for joint GMP inspections.

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.

 

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