PROCESS VALIDATION IS NOT PROPER TIME TO CONFIRM ACCURACY OF SPECS

Executive Summary

PROCESS VALIDATION IS NOT PROPER TIME TO CONFIRM ACCURACY OF SPECS, FDA Newark District Pre-Approval Program Director Heather Pedersen told attendees of an NAPM/NPA workshop May 3. Speaking at the National Association of Pharmaceutical Manufacturers and National Pharmaceutical Association's "Vital Signs for Successful Validation" conference in Newark, Pedersen said generic firms often try to "tweak" product specification in the validation stage because they are not predetermined in development, reducing the integrity of the validation process itself.