ABSTRACT
This chapter discusses the leveraging prior information to reduce sample size for a Process Performance Qualification (PPQ) and demonstrates how the use of historical manufacturing data can dramatically reduce the sampling and testing required in re-validation or technology transfer situations, without sacrificing statistical rigor or confidence about the process. Biopharmaceutical manufacturing processes are considered in three stages: Process Development and Design, Process Qualification, and Continued Process Verification. The prior for the informative sample size determination in an example such as this is most appropriately based on historical data. Sensitivity analyses may be requested by regulatory reviewers to explore the influence of alternative priors for the specific modelling circumstances. Evaluation of manufacturing performance and risk, whether to plan or analyze PPQ batches or monitor commercial manufacture, is often performed using traditional statistical techniques such as TIs, control charts, and a capability indices.
