PPQ_occurve: Operating Characteristic (OC) Curves for 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 OC curve to show the PPQ plan, given lower and upper specification limits.

Usage

PPQ_occurve(attr.name, attr.unit, Llim, Ulim, mu, sigma, n, n.batch, k, add.reference)

Arguments

attr.name	(optional) user-defined attribute name
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
add.reference	logical; if TRUE, then add reference OC curves (Baseline and High Performance) in the plot.

Value

OC curves for specification test and PPQ plan.

Author(s)

Yalin Zhu

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 rl_pp.

Examples

## Not run: 
PPQ_occurve(attr.name = "Sterile Concentration Assay", attr.unit="%", Llim=95, Ulim=105,
mu=97, sigma=seq(0.1, 10, 0.1), n=10, k=2.373, add.reference=TRUE)
PPQ_occurve(attr.name = "Sterile Concentration Assay", attr.unit="%", Llim=95, Ulim=105,
mu=100, sigma=seq(0.1, 10, 0.1), n=10, k=2.373, add.reference=TRUE)
PPQ_occurve(attr.name = "Sterile Concentration Assay", attr.unit="%", Llim=95, Ulim=105,
mu=seq(95,105,0.1), sigma=1, n=10, k=2.373)
PPQ_occurve(attr.name = "Sterile Concentration Assay", attr.unit="%", Llim=95, Ulim=105,
mu=seq(95,105,0.1), sigma=1, n=10, k=2.373, add.reference=TRUE)

PPQ_occurve(attr.name = "Protein Concentration", attr.unit="%", Llim=90, Ulim=110,
mu=seq(90, 110, 0.1), sigma=1.25, k=2.373)

## Only display referece curves, leave k as NULL by default
PPQ_occurve(attr.name = "Sterile Concentration Assay", attr.unit="%LC", Llim=95, Ulim=105,
mu=98, sigma=seq(0.1, 10, 0.1), n=10, add.reference=TRUE)

## End(Not run)

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