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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1.1.0 by Yalin Zhu, a year ago,

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Authors: Yalin Zhu [aut, cre] , Merck & Co. , Inc. [cph]

Documentation:   PDF Manual  

GPL-3 license

Imports ggplot2, plotly

Suggests knitr, rmarkdown, devtools

See at CRAN