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) }