Process validation is divided into three stages: process design, process confirmation, and continuous process validation. The work content and participants involved in different stages are different, but all require the support of relevant statistical analysis work. This speech will systematically sort out and introduce the application of different statistical methods in various stages, such as the application of DOE in the process development stage, the application of comparative analysis in the technology transfer stage, the application of equivalence analysis in small-scale model confirmation, the application of Monte Carlo simulation in process characterization, the application of stability analysis in method evaluation, and the application of control charts in continuous process validation.
