PPQplan
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.
- Version1.1.0
- R version≥ 3.2.0
- LicenseGPL-3
- Needs compilation?No
- Languageen-US
- Last release10/08/2020
Documentation
Team
Yalin Zhu
Merck & Co.
Inc.
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- Depends1 package
- Imports2 packages
- Suggests3 packages