Description Usage Arguments Value Author(s) References See Also Examples
The function for dynamically plotting (ggplot) the heatmap to evaluate the PPQ plan based on the specification test, given lower and upper specification limits.
1 2 | PPQ_ggplot(attr.name, attr.unit, Llim, Ulim, mu, sigma, n, n.batch, k,
test.point, dynamic)
|
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 |
dynamic |
logical; if |
Dynamic Heatmap (or Contour Plot) for PPQ Assessment.
Yalin Zhu
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.
PPQ_pp
and PPQ_occurve
.
1 2 3 4 5 6 7 8 9 10 | ## Not run:
mu <- seq(95, 105, 0.1)
sigma <- seq(0.1,1.7,0.1)
PPQ_ggplot(attr.name = "Sterile Concentration Assay", attr.unit = "%", Llim=95, Ulim=105,
mu = mu, sigma = sigma, k=2.373, dynamic = FALSE)
test <- data.frame(mu=c(97,98.3,102.5), sd=c(0.55, 1.5, 0.2))
PPQ_ggplot(attr.name = "Sterile Concentration Assay", attr.unit = "%", Llim=95, Ulim=105,
mu = mu, sigma = sigma, k=2.373, test.point = test)
## End(Not run)
|
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