Process Performance Qualification (PPQ) Plans in Chemistry, Manufacturing and Controls (CMC) Statistical Analysis
A General Heatmap for Dynamically Assessing Power of the Sampling Plan...
Estimating K-factors for Tolerance Intervals Based on Howe's Method
Heatmap/Contour Plot for Assessing Power of the CQA PPQ Plan Using Pre...
Operating Characteristic (OC) Curves for the CQA PPQ Plan using Predic...
Probability of Passing PPQ Test using Prediction Interval
Probability of Passing General Upper and/or Lower Specification Limit
Heatmap/Contour Plot for Assessing Power of the CQA PPQ Plan Using Gen...
Heatmap/Contour Plot for Dynamically Assessing Power of the CQA PPQ Pl...
Operating Characteristic (OC) Curves for the CQA PPQ Plan Using Genera...
Probability of Passing PPQ Test Using General Multiplier
Probability of Passing Specification Test for a Release Batch
Heatmap/Contour Plot for Assessing Power of the PPQ Plan using Toleran...
Operating Characteristic (OC) Curves for the PPQ Plan using Tolerance ...
Probability of Passing PPQ Test using Tolerance Interval
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.
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