Understand how to better assess PPQ sample size selection

Overview

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