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Report: Global API GMP Inspection Coordination Increasing Under Joint Program

Executive Summary

Regulators report that an international collaboration on GMP inspections of API sites has bolstered the exchange of information between participating health authorities, yet the information technology system that supports the system could use some improvement.

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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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