Getting to the root causes of variation – and saving a product line
Getting to the root causes of variation – and saving a product line
4 Pagesor three years a major generics pharmaceutical company struggled to correct variations in the dissolution rate of a high-demand, high-volume time-release product. They attempted to stabilize the dissolution rate by adjusting process parameters, replacing equipment, and working with API and excipient suppliers to get to the root of the recurring problem. Nevertheless, the variation and high product failure rate continued. After 161 investigations – and facing the possibility of the FDA shutting down the product line – the company turned to Tunnell. Process Capability and Control Getting to the root causes of variation – and saving a product line PROCESS IMPROVEMENT The Result: Employing its unique Process Capability & Control (PC&C) methodology, Tunnell uncovered the key drivers of
