Data Integrity Inspections Go Global

As FDA and other regulatory authorities throughout the world learn how to conduct the type of inspections that have put a spotlight on data integrity failures in India, they are warning that no manufacturer, no matter how sophisticated they are, no matter where they’re located, is immune from this potentially devastating issue.

Data integrity inspections that have disrupted pharmaceutical exports from India to the US and Europe are spreading to exporters in China and other countries, as well as to domestic US and European manufacturers that may be unprepared for them.

Even as FDA authorities warn global manufacturers against complacency, there are indications that they remain vulnerable to the type of...

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