Determining the Best Estimate of Probability of Passing Multiple Stage Tests: Part 1–Content Uniformity

Pramote Cholayudth

Pramote Cholayudth previously was the managing director of the Professional Conference Center, Ltd. He currently is a validation consultant to Biolab Co., Ltd., in Thailand. He is the founder and manager of PM consult, cpramote2000@yahoo.com.

Pharmaceutical Technology, Pharmaceutical Technology-05-02-2021, Volume 45, Issue 5
Pages: 36-43

This article introduces a practical approach to determining the best estimate for probability of passing uniformity of dosage units (content uniformity) using probability vs. lot coverage charts and tables constructed using simulated probability and lot coverage (LC1) data.

Peer-Reviewed

Submitted: August 24, 2020; Accepted: October 12, 2020

Abstract

This article introduces a practical approach to determining the best estimate for probability of passing uniformity of dosage units (content uniformity) using probability vs. lot coverage charts and tables constructed using simulated probability and lot coverage (LC1) data. The best estimation concept is to demonstrate that the probability estimates, especially for those approaching 100%, are slightly different (deviated) from the exact calculated values by not more than (NMT) the statistically acceptable deviation limits.

About the author

Pramote Cholayudth is an industrial pharmacist with more than 40 years of experiences. He is a guest speaker on Process Validation to industrial pharmaceutical scientists organized by Thailand’s FDA. He is the founder and manager of PM Consult and can be contacted via cpramote2000@yahoo.com.

Article details

Pharmaceutical Technology
Vol. 45, No. 5
May 2021
Pages: 36-43

Citation

When referring to this article, please cite it as P. Cholayudth, “Determining the Best Estimate of Probability of Passing Multiple Stage Tests: Part 1–Content Uniformity,” Pharmaceutical Technology 45 (5) 2021.

download issueDownload Issue : Pharmaceutical Technology-05-02-2021