Handling Regulatory Inquiries on Risk-Based Stability Justification
With increasing adoption of risk-based approaches in pharmaceutical stability programs, regulatory agencies have started scrutinizing the scientific basis for protocol design decisions. This article provides guidance on handling regulatory inquiries on risk-based stability justification, ensuring alignment with ICH Q9 and GxP documentation expectations. 🔎 Why Regulators Question Risk-Based Justifications Agencies like USFDA and EMA expect…
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