Process Performance Qualification (PPQ) Plans in Chemistry, Manufacturing and Controls (CMC) Statistical Analysis

Assessment for statistically-based PPQ sampling plan, including calculating the passing probability, optimizing the baseline and high performance cutoff points, visualizing the PPQ plan and power dynamically. The analytical idea is based on the simulation methods from the textbook "Burdick, R. K., LeBlond, D. J., Pfahler, L. B., Quiroz, J., Sidor, L., Vukovinsky, K., & Zhang, L. (2017). Statistical Methods for CMC Applications. In Statistical Applications for Chemistry, Manufacturing and Controls (CMC) in the Pharmaceutical Industry (pp. 227-250). Springer, Cham."


Reference manual

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0.1.0 by Yalin Zhu, 8 months ago

Browse source code at

Authors: Yalin Zhu

Documentation:   PDF Manual  

GPL (>= 2) license

Imports tolerance, ggplot2, plotly

Suggests knitr, rmarkdown

See at CRAN