Regulatory Expectations for Excursion Trending and CAPA Effectiveness
In pharmaceutical stability programs, repeated temperature or humidity excursions are not just isolated incidents — they may signal systemic weaknesses. Regulatory authorities such as the USFDA and EMA expect robust trending and effective corrective and preventive actions (CAPA) to prevent recurrence. This article outlines regulatory expectations and practical strategies for trending excursions and verifying CAPA…
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