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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