Step-by-Step Guide to Root Cause Analysis in Stability Deviations
In pharmaceutical stability studies, deviations can compromise data integrity and regulatory acceptance. When deviations occur—such as out-of-specification (OOS), out-of-trend (OOT), temperature excursions, or sampling errors—it’s critical to conduct a thorough root cause analysis (RCA). This guide provides a structured, step-by-step method to execute RCA for stability-related deviations, ensuring CAPA alignment and GMP compliance. 📝 Step…
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