Heatmap/Contour Plot for Assessing Power of the CQA PPQ Plan Using General Multiplier.

Source: R/PPQ_ctplot.R

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

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.

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.

Author

Yalin Zhu

Examples

if (FALSE) {
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)
}