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Quality by Design: Next Steps to Realize Opportunities? - page 36 / 37

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Level of QbD: Metrics

Achievement of pre-determined product and process performance characteristics that are adequate for the intended on every batch and in an established cycle time

Performance characteristics are selected or developed  through scientific studies  

to identify target characteristics

of all relevant sources of variability in the target characteristics

to evaluate the effectiveness of testing/controls strategies to mitigate the risk of variability

Metrics

Right-first-time

Process Time/Cycle time

Ability to reliably predict impact of changes  

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