PPQ_ctplot: Heatmap/Contour Plot for Assessing Power of the CQA PPQ Plan...

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

Description

The function for plotting the heatmap to evaluate the PPQ plan based on the specification test, given lower and upper specification limits.

Usage

PPQ_ctplot(attr.name, attr.unit, Llim, Ulim, mu, sigma, n, n.batch, k, test.point)

Arguments

attr.name	(optional) user-defined attribute name for PPQ assessment
attr.unit	(optional) user-defined attribute unit
Llim	lower specification limit
Ulim	upper specification limit
mu	hypothetical mean of the attribute
sigma	hypothetical standard deviation of the attribute
n	sample size (number of locations) per batch
n.batch	number of batches for passing PPQ during validation
k	general multiplier for constructing the specific interval
test.point	(optional) actual process data points for testing whether the processes pass PPQ

Value

Heatmap (or Contour Plot) for PPQ Assessment.

Author(s)

Yalin Zhu

References

Burdick, R. K., LeBlond, D. J., Pfahler, L. B., Quiroz, J., Sidor, L., Vukovinsky, K., & Zhang, L. (2017). Statistical Applications for Chemistry, Manufacturing and Controls (CMC) in the Pharmaceutical Industry. Springer.

See Also

PPQ_pp and PPQ_occurve.

Examples

## Not run: 
mu <- seq(1.6,3.4,0.05)
sigma <- seq(0.05,0.8,0.01)
PPQ_ctplot(attr.name = "Total Protein", attr.unit = "mg/mL", Llim=1.5, Ulim=3.5,
mu = mu, sigma = sigma, k=2.373)

## Example verifying simulation resutls in the textbook page 249
mu <- seq(95, 105, 0.1)
sigma <- seq(0.2, 5, 0.1)
PPQ_ctplot(attr.name = "Composite Assay", attr.unit = "%LC", Llim=95, Ulim=105,
mu = mu, sigma = sigma, k=2.373)
mu <- seq(90, 110, 0.5)
PPQ_ctplot(attr.name = "Composite Assay", attr.unit = "%LC", Llim=90, Ulim=110,
mu = mu, sigma = sigma, k=2.373)

mu <- seq(95,105,0.1)
sigma <- seq(0.1,2.5,0.1)
PPQ_ctplot(attr.name = "Sterile Concentration Assay", attr.unit = "%", Llim=95, Ulim=105,
mu = mu, sigma = sigma, k=2.373)
test <- data.frame(mean=c(97,98.3,102.5), sd=c(0.55, 1.5, 1.2))
PPQ_ctplot(attr.name = "Sterile Concentration Assay", attr.unit = "%", Llim=95, Ulim=105,
mu = mu, sigma = sigma, k=2.373, test.point=test)

## End(Not run)

Example output

PPQplan documentation built on Jan. 13, 2021, 9:49 p.m.