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.
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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
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.
Warning Letters Special Report: Pandemic Drove Focused Inspections, Alternative Approaches
In the first part of our in-depth series, the Pink Sheet outlines how 2022 warning letters reflected agency’s efforts to overcome COVID-19 travel restrictions. As pandemic abates, a new, less inspection-intensive normal could emerge.
The Next New Thing In FDA Inspections: Poor Root Cause Investigations
Data integrity failures are so yesterday. Now it’s all about poor investigations into out-of-specification results.