JVT Journal Articles
Vol. 23, Issue 3, Jun 2017

This month's issue of Journal of GXP Compliance is sponsored by Waters Corporation, a company that has pioneered a connected portfolio of separation and analytical science, laboratory informatics, and mass spectrometry, Waters’ technology breakthroughs and laboratory solutions provide an enduring platform for customer success.
Drew N. Kelner
Ira S. Krull
Robert J. Duff
Tamer Eris
This section provides some examples from the literature that discuss the stability-indicating properties of purity methods for biologics, with a focus on best practices that can be gleaned from previously published work.
Binbing Yu
Harry Yang
Pin Ren
In this article, we propose the Bayesian method for constructing tolerance limits for zero-inflated discrete data. The proposed method is a useful approach to setting alert and action limits for quality control of zero-inflated attributes arising from pharmaceutical manufacturing.
George Omae
Roberta Goode
Frequently asked questions about statistics in validation.
Mohammad Ovais
This article reviews the current approaches to qualifying sampling procedures and addresses misconceptions in recovery studies.

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