AQbD in practice: Risk assessment based on FMEA methodology is applied for complex sample preparations and chromatographic impurities separation

The presentation will reveal Teva's global approach applied on method development and validation based on risk assessment (FMEA: Failure Mode and Effect Analysis) and statistical based software as JMP and Fusion. The case studies will focus on sample preparation parameters criticality assessment based on FMEA and on optimal chromatographic separation of impurities.