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Warning Letters Special Report: Why Investigations Once Again Led Drug GMP Problem Areas In 2022 And What To Do About It

Executive Summary

In this fourth installment of our in-depth series, the Pink Sheet reports that inadequate investigations topped the list of problem areas cited in US FDA 2022 drug GMP warning letters. Experts share key pointers on investigating complaints, OOS results, nonconformances and deviations.

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Warning Letters Special Report: Top Problem Areas Were Investigations, Testing And Sterility

Drug GMP warning letters last year cited testing inadequacies and poor batch failure and complaint investigations more than any other problem, this third part of our in-depth series reports, followed by sterility assurance issues that were somewhat driven by concerns about water systems. Most were US-focused – a pandemic limitation but also a reminder that drug GMP problems are not limited to China and India.

More Change With Less Hoopla To FDA Out-Of-Specification Investigations Policy

Agency’s revised OOS guidance clarifies positions on outlier test results, averaging of HPLC results and some finer points around OOS questions. These could marginally improve compliance but won’t impact industry with nearly the force of the original 2006 guidance or the 1993 court ruling that preceded it.

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