Documenting Laboratory Errors vs. True OOS Findings in Stability Data
In pharmaceutical stability studies, not all out-of-specification (OOS) results point to actual product failure. Some deviations arise from laboratory errors — analyst mistakes, equipment glitches, or sample handling issues. For regulatory compliance, it is essential to document whether the OOS is a genuine quality concern or a procedural mishap. This article outlines how pharma professionals…
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