ICH compliance – StabilityStudies.in

Always Record Even Minor Deviations from Storage Conditions in Stability Studies

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…

Stability Study Tips

Real-Time Stability Testing Design Considerations

Real-Time Stability Testing Design Considerations Key Factors for Designing Effective Real-Time Stability Testing Protocols Real-time stability testing is a cornerstone of pharmaceutical quality assurance. This guide explores essential design considerations to help pharmaceutical professionals implement robust and regulatory-compliant stability protocols. By applying these insights, you’ll enhance shelf-life prediction accuracy, ensure ICH compliance, and support product…

Real-Time and Accelerated Stability Studies, Stability Testing Types