Root Cause Investigation: Resolving Chronic OOS Results with Multivariate Analysis

The Challenge

A specialty pharmaceutical company struggled to identify the root cause behind a persistent series of out-of-specification (OOS) batch results. Previous internal investigations had failed to substantiate a root cause, putting product supply at risk.

Our Solution

Light Pharma applied its proprietary investigation tools and multivariate data analysis to resolve the issue definitively, identifying interactions between process parameters that traditional univariate analysis had missed.

Our Approach

Results