Responding to Regulatory Queries on Stability Deviations
Regulatory agencies such as the USFDA, EMA, and CDSCO closely scrutinize how pharmaceutical companies respond to stability-related deviations. A well-crafted, science-based response can protect your product, ensure continued market access, and avoid warning letters. This article outlines a structured approach to answering regulatory queries related to stability testing failures, out-of-specification (OOS) results, and deviations. 📝…
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