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‘Global Allegiance’ of Inspectorates Emerging

This article was originally published in The Gold Sheet

Executive Summary

Drug regulatory agencies around the world are beginning to coordinate their inspection processes, which could reduce global drug manufacturers’ burden of hosting multiple GMP inspections.Some are piloting joint inspections, with a pilot for active pharmaceutical ingredient manufacturers concluding next month, and a second for drug product manufacturers under way.

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BRIC Nations Slow to Join PIC/S Inspection Coordination Effort

PIC/S could play an even greater role in coordinating drug GMP inspections if its members included inspectorates of all the major drug exporting nations. While India appears to lack interest, Japan, China and others have been working to qualify for membership.

Mutual Reliance Blossoming Among U.S. FDA, EMA, Other Inspectorates

U.S. FDA, EMA and other agencies are increasingly relying on each others' inspection results in an effort to spread their inspectional resources throughout the furthest corners of the globe.

Mutual Reliance Blossoming Among FDA, EMA, Other Inspectorates

FDA, EMA and other agencies are increasingly relying on each others' inspection results in an effort to spread their inspectional resources throughout the furthest corners of the globe. Inspection coordination remains somewhat ad hoc, with EMA keeping a spreadsheet for some and PIC/S enabling others. EMA's EudraGMP database is touted as a coordination hub.

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