Operating Characteristic (OC) Curves for the CQA PPQ Plan Using General Multiplier.

Source: R/PPQ_occurve.R

The function for plotting the OC curve to show the PPQ plan, given lower and upper specification limits.

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.

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.

Author

Yalin Zhu

Yalin Zhu

Examples

if (FALSE) {
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)
}