Analytical Method Lifecycle Management: Ppk Improvement from 0.8 to 1.4
The Challenge
A pharmaceutical company identified analytical methods with significant variation relative to specifications (Ppk = 0.8) that had not yet caused out-of-specification results but posed growing risk of future OOS events and regulatory citations.
Our Solution
Light Pharma identified execution variations and proposed systematic reduction strategies, implementing method improvements before failures occurred — a proactive approach that protected product quality and avoided costly investigations.
Our Approach
Method capability assessment across product portfolio
Variation source identification through systematic analysis
Method optimization and robustness improvement
Expanded deployment across similar methods and sites
Results
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