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Pharma Stability: Insights, Guidelines, and Expertise

Tag: QA Oversight

Always Record Even Minor Deviations from Storage Conditions in Stability Studies

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Understanding the Tip: What qualifies as a deviation: Any fluctuation outside the validated storage conditions—whether temperature, humidity, or light exposure—constitutes a deviation. Even brief or minor excursions can affect product stability, especially for sensitive formulations. Ignoring small changes may compromise the reliability of the data and lead to misleading conclusions about product shelf life. Why…

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