How to Prepare for GMP Inspections in Stability Testing Units
Stability testing units are increasingly scrutinized during GMP inspections by global regulators like the USFDA, EMA, WHO, and CDSCO. Failures in documentation, sample traceability, and environmental monitoring often trigger major audit observations, including 483s and warning letters. Proactive preparation is essential to avoid these pitfalls. This guide outlines the critical steps stability teams should follow…
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