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Lessons from ISPE Quality Metrics Pilot: Start Small and Be Aware of Costs

This article was originally published in The Gold Sheet

Executive Summary

An ISPE report recommended FDA start with five well-understood metrics for its pharmaceutical quality metrics initiative and to add more later on. ISPE also says that though feasible, implementing a quality metrics program will be expensive, costing industry anywhere from $35 million to more than $100 million per year.

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