Regulatory Expectations for Excursion Trending and CAPA Effectiveness
In the pharmaceutical industry, recurring temperature or humidity excursions during stability studies signal not just isolated failures but potential systemic breakdowns. Regulators such as the USFDA, EMA, and WHO expect a proactive, trend-based approach to monitoring such incidents. Moreover, they demand a robust system to evaluate the effectiveness of Corrective and Preventive Actions (CAPA) linked…
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