Stability Study Deviations: Handling Unexpected Freeze-Thaw Events
Stability Study Deviations: Handling Unexpected Freeze-Thaw Events Stability Study Deviations: Handling Unexpected Freeze-Thaw Events in Thermal Cycling Programs Unexpected freeze-thaw events during stability studies can compromise product integrity and regulatory compliance, especially for temperature-sensitive formulations like biologics, injectables, and cold chain products. These deviations—whether due to equipment failure, shipping excursions, or human error—must be systematically…
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