Operating Characteristic (OC) Curves for the CQA PPQ Plan using Prediction Interval.

The function for plotting the OC curves and optimizing the baseline and high performance PPQ plans, given lower and upper specification limits.

pi_occurve(attr.name, attr.unit, Llim, Ulim, mu, sigma, n, n.batch, alpha, add.reference)

Arguments

attr.name	user-defined attribute name
attr.unit	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
alpha	significant level for constructing the prediction 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

pi_pp and rl_pp.

Author

Yalin Zhu

Examples

if (FALSE) {
pi_occurve(attr.name = "Total Protein", attr.unit = "mg/mL",
sigma = seq(0.01,1,0.01))
pi_occurve(attr.name = "Total Protein", attr.unit = "mg/mL",
sigma = seq(0.01,1,0.01), n.batch=3)
# Baseline curve
pi_occurve(attr.name = "Total Protein", attr.unit = "mg/mL",
sigma = seq(0.01,1,0.01), alpha = 0.1135434)
# High performance curve
pi_occurve(attr.name = "Total Protein", attr.unit = "mg/mL",
sigma = seq(0.01,1,0.01), alpha = 0.0225518)

# 95% with reference curves
pi_occurve(attr.name = "Total Protein", attr.unit = "mg/mL",
sigma = seq(0.01,1,0.01), add.reference=TRUE)
pi_occurve(attr.name = "Composite Assay", attr.unit = "%",
mu = 100, sigma = seq(0.1,6,0.1), Llim=95, Ulim=105, n.batch=1, add.reference=TRUE)

pi_occurve(attr.name = "Sterile Concentration Assay", attr.unit="%",
mu=97, sigma=seq(0.1, 10, 0.1), Llim=95, Ulim=105, n=10, add.reference=TRUE)

pi_occurve(attr.name = "Sterile Concentration Assay", attr.unit="%",
mu=100, sigma=seq(0.1, 10, 0.1), Llim=95, Ulim=105, n=10, add.reference=TRUE)

pi_occurve(attr.name = "Sterile Concentration Assay", attr.unit="%",
mu=seq(95,105,0.1), sigma=1, Llim=95, Ulim=105, n=10, add.reference=TRUE)

pi_occurve(attr.name = "Protein Concentration", attr.unit="%",
mu=seq(90, 110, 0.1), sigma=1.25, Llim=90, Ulim=110, add.reference=TRUE)
}