Package: CleaningValidation 1.0

Xiande Yang

CleaningValidation: Cleaning Validation Functions for Pharmaceutical Cleaning Process

Provides essential Cleaning Validation functions for complying with pharmaceutical cleaning process regulatory standards. The package includes non-parametric methods to analyze drug active-ingredient residue (DAR), cleaning agent residue (CAR), and microbial colonies (Mic) for non-Poisson distributions. Additionally, Poisson methods are provided for Mic analysis when Mic data follow a Poisson distribution.

Authors:Mohamed Chan [aut], Wendy Lou [aut], Xiande Yang [aut, cre]

CleaningValidation_1.0.tar.gz
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CleaningValidation.pdf |CleaningValidation.html✨
CleaningValidation/json (API)

# Install 'CleaningValidation' in R:
install.packages('CleaningValidation', repos = c('https://chandlerxiandeyang.r-universe.dev', 'https://cloud.r-project.org'))

Peer review:

Bug tracker:https://github.com/chandlerxiandeyang/cleaningvalidation/issues

On CRAN:

2.70 score 424 downloads 34 exports 65 dependencies

Last updated 6 months agofrom:576f02ddb2. Checks:OK: 7. Indexed: yes.

TargetResultDate
Doc / VignettesOKNov 15 2024
R-4.5-winOKNov 15 2024
R-4.5-linuxOKNov 15 2024
R-4.4-winOKNov 15 2024
R-4.4-macOKNov 15 2024
R-4.3-winOKNov 15 2024
R-4.3-macOKNov 15 2024

Exports:cv01_dfcleancv02_nonpro_oos_reswabcv03_usl_unificationcv04_histogram_kdecv05_sw_norm_test_1cv06_sw_norm_test_2cv07_median_control_chartcv071_median_control_chartcv08_variability_chartcv09_kw_testcv10_dunn_test_vs_controlcv11_vca_by_mediancv12_kde_ppucv13_poisson_testcv14_dispersion_testcv15_mic_mutatecv16_u_chartcv17_cusumcv18_ewmacv19_poisson_simplecv20_poisson_fixedcv21_poisson_mixedcv22_var_random_effectcv23_random_effect_coefcv24_vca_miccv25_qbinom_ppucv26_qpoisson_ppucv27_anscombe_ppucv28_freeman_ppucv29_mic_ppucv30_dar_car_mic_ppuEq_CAREq_DAREq_Mic

Dependencies:abindAERbackportsbootbroomcarcarDataclicolorspacecowplotcpp11DerivdoBydplyrdunn.testfansifarverFormulagenericsggplot2gluegtableisobandlabelinglatticelifecyclelme4lmtestmagrittrMASSMatrixMatrixModelsmgcvmicrobenchmarkminqamodelrmunsellnlmenloptrnnetnumDerivpbkrtestpillarpkgconfigpurrrquantregR6RColorBrewerRcppRcppEigenrlangsandwichscalesSparseMstringistringrsurvivaltibbletidyrtidyselectutf8vctrsviridisLitewithrzoo

Readme and manuals

Help Manual

Help pageTopics
Cleaning Validation PackageCleaningValidation CV
Clean and preprocess residue data for stability and capability analysiscv01_dfclean
Summarize Non-Process Related OOS and Reswab Data Which May Not Be Included in the Analysiscv02_nonpro_oos_reswab
Unify USL Percentages for Specified Residuecv03_usl_unification
Plot Histogram with Kernel Density Estimate Curvecv04_histogram_kde
Perform Shapiro-Wilk Normality Testcv05_sw_norm_test_1
Perform Shapiro-Wilk Normality Test on Two Variablescv06_sw_norm_test_2
Median Control Chart and Density Plotcv07_median_control_chart
Median Control Chartcv071_median_control_chart
Variability Chart for Cleaning Eventscv08_variability_chart
Kruskal-Wallis Test for Residue Percentagescv09_kw_test
Dunn's Test for Residuecv10_dunn_test_vs_control
Variability Components Analysis by Median with Bootstrapcv11_vca_by_median
Calculate PPU using KDE density estimationcv12_kde_ppu
Poisson Goodness-of-Fit Testcv13_poisson_test
Dispersion Test for Poisson Regression Modelscv14_dispersion_test
Calculate Mic Statisticscv15_mic_mutate
Create a u-Chart for Poisson-distributed Datacv16_u_chart
Create a CUSUM Chart for Poisson-distributed Datacv17_cusum
Exponentially Weighted Moving Average (EWMA) Chartcv18_ewma
Poisson Fixed Effect Model Summarycv19_poisson_simple
Poisson Fixed Effect Modelcv20_poisson_fixed
Poisson Mixed Effect Model Summarycv21_poisson_mixed
Extract Variance of Random Effectscv22_var_random_effect
Extract Random Effect Coefficientscv23_random_effect_coef
Variance Component Analysis for Microbial Countscv24_vca_mic
Binomial Process Performance Calculationcv25_qbinom_ppu
Calculate Process Performance Index using Poisson Distributioncv26_qpoisson_ppu
Process Performance Calculation using Anscombe's Transformationcv27_anscombe_ppu
Calculate Ppu using Freeman's Transformationcv28_freeman_ppu
Calculate Mic Ppu with Five Methodscv29_mic_ppu
Calculate DAR, CAR, and Mic Ppu Values and Identify the Overall Minimumcv30_dar_car_mic_ppu
Equipment Cleaning Data for CAREq_CAR
Equipment Cleaning Data for DAREq_DAR
Equipment Cleaning Data for Microbial BioburdenEq_Mic