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Pharma Stability: Insights, Guidelines, and Expertise

Tag: thermal risk mitigation clinical trials

Thermal Excursion Qualification for Clinical Trial Supplies

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Thermal Excursion Qualification for Clinical Trial Supplies Thermal Excursion Qualification for Clinical Trial Supplies: A GMP-Centric Guide Clinical trial supplies—including investigational medicinal products (IMPs), comparators, and reference drugs—must remain within their labeled storage conditions to ensure patient safety and data integrity. However, real-world logistics often expose these supplies to temperature excursions. Proactively qualifying these excursions…

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Freeze-Thaw and Thermal Cycling Studies, Stability Testing Types

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  • Calibrate and Validate RH Sensors and Data Loggers to Maintain Stability Compliance

    Understanding the Tip: Why RH sensors and data loggers require control: Relative humidity (RH) sensors and data loggers are essential for ensuring that stability chambers… Read more

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