Documenting Excursions and OOS Events in Reports
Excursions and out-of-specification (OOS) results are inevitable in long-term pharmaceutical stability studies. Whether due to chamber malfunction, unexpected assay drift, or analytical errors, these events must be thoroughly documented in the stability report. Regulatory agencies such as the USFDA, CDSCO, and EMA require a standardized approach to documenting, investigating, and concluding on such deviations. This…
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