rl_pp: Probability of Passing Specification Test for a Release Batch

In PPQplan: Process Performance Qualification (PPQ) Plans in Chemistry, Manufacturing and Controls (CMC) Statistical Analysis

Description

The function for calculating the probability of passing critical quality attributes (CQA) specification test .

Usage

rl_pp(Llim, Ulim, mu, sigma, NV)

Arguments

Llim	lower specification limit
Ulim	upper specification limit
mu	hypothetical mean of the attribute
sigma	hypothetical standard deviation of the attribute
NV	nominal volume for the specification test.

Value

A numeric value of the passing/acceptance probability

Author(s)

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, pi_pp and ti_pp.

Examples

rl_pp(Llim=1.5, Ulim=3.5, mu=2.5, sigma=0.8)

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