FDA, EMEA partner on inspections program

6/3/2008

WASHINGTON The Food and Drug Administration and the European Medicines Agency have joined together to pilot a good manufacturing practice inspections program.

Under the bilateral agreement, the program will apply to facilities in both the U.S. and the European Union. Also, joint inspections of active pharmaceutical ingredient facilities in countries outside the U.S. and the EU will be part of the program.

The agencies will pilot a GMP information exchange covering inspection schedules and results. Information on facilities that have been inspected would be shared so the agencies could get greater inspection coverage and better identify API production sites in countries outside the U.S. and the EU.

“The collaboration on inspections should result in more effective use of resources and a higher safety level of product from third countries,” the European Commission, which lists new GMP initiatives the two agencies undertake, said.

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