Regulators triple-team API makers worldwide

Regulators from three regions of the world have collectively inspected 1,000 API-manufacturing sites over the past 18 months and are sharing the data. More facilities are being inspected, there are fewer duplicate inspections--and more inspections of value to more than one regulator.

The inspections are part of a two-year pilot program among the FDA and regulatory authorities from Europe and Australia to see if they can pool resources to keep watch over manufacturing plants in third-country locations. An interim report counts 499 sites inspected by the EU, 352 by the FDA and 195 by Australia's Therapeutic Goods Administration. Among the report's findings is that despite improvement, the authorities are still duplicating some inspections.

Inspection data are kept in a master file available to the collaborators. The pilot has demonstrated that the sharing of inspection data makes staff available for other priorities, including inspections of plants that have never been visited.

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