How to Write a CAPA Plan for OOS-Related Deviations in Stability Studies
Out-of-Specification (OOS) results in stability studies are red flags that demand immediate attention. Regulatory authorities like USFDA and EMA expect companies to not only investigate the root cause thoroughly, but also to implement a robust Corrective and Preventive Action (CAPA) plan. A well-documented and logically structured CAPA plan is essential to address deviations and prevent…
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