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SOP-QC-009Version 3.0Effective 2025-12-01Owner: Quality ControlEffective

Stability Program

Fictional document for the demonstration.

§4.2 Timepoint review

Results at each stability timepoint are reviewed against specification and against the trend from earlier timepoints.

§4.3 Out-of-trend results

A result that is within specification but departs from the established trend is investigated as out-of-trend before the next timepoint.