Handling Excursions in Light and Humidity Conditions During Stability Studies
Stability studies are critical for ensuring the quality, safety, and efficacy of pharmaceutical products. However, even in well-controlled environments, excursions in light and humidity can occur due to sensor malfunctions, power outages, or system calibration issues. Regulatory agencies like the USFDA, EMA, and CDSCO expect robust procedures for detecting, investigating, documenting, and mitigating such excursions….
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