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Understand how to better assess PPQ sample size selection


This article details two statistical methodologies for calculating the necessary number of process performance qualification (PPQ) runs: the tolerance interval (TI) method and the process capability (PpK) method.

Download the whitepaper to read more.

Key Takeaways

  • Initial risk assessment

  • Reliability of the sample size

  • Tolerance Interval (TI) Method

  • Process Capability Method

  • Intra-batch and Inter-batch Variations