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FDA: Early Process Validation Studies Could Avert Preapproval Inspection Findings

Executive Summary

FDA officials stress the importance of nailing down the design of manufacturing processes early on to support later-stage process validation studies. Investigators find many of the deficiencies noted in preapproval inspections stem from inadequate Stage 1 process validation work. The best process validation programs are the ones that employ robust risk management models that explore how multiple variables can affect the manufacturing process.

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