Regulatory Guidance on Deviation Reporting in Stability Testing
In pharmaceutical stability testing, deviations—planned or unplanned—can significantly affect product quality and regulatory compliance. Regulatory authorities such as USFDA, EMA, and CDSCO closely examine how deviations are reported, assessed, and linked to corrective actions. A robust deviation reporting process is not only a GMP requirement but also a key quality system indicator during inspections. 📝…
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