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“The adoption of Superior manufacturing technologies may possibly pose a challenge to The present regulatory framework due to the fact most laws were being developed based upon common batch producing approaches under a unified pharmaceutical good quality method,” described Woodcock in her testimony. “Subsequently, FDA has introduced an effort
processes and To judge the necessity for revalidation. This is toprocedures and To judge the need for revalidation. This is toContinual Advancement: APQR promotes a society of steady enhancement by offering insights into system enhancements, quality Command steps, and product optimization.This document discusses the qualification of dissolution tak