OUT OF TREND (OOT)

Description

Out-of-Trend (OOT) results in pharma refer to analytical results that deviate from historical trends, even though they might still be within specification limits.

While not immediately failing quality standards, OOT results are crucial red flags as they might signal underlying issues in the manufacturing process or product stability. Timely identification and investigation of OOT results are essential to prevent potential product quality problems and ensure patient safety.