In the Autumn 2009 Issue of JVT
Author: Susan Haigney

The Autumn 2009 issue of the Journal of Validation Technology (JVT) continues to showcase new columns, expert articles, and peer-reviewed papers. The following are highlights of what this issue has to offer our readers.

Peer-Reviewed Papers
Pramote Cholayudth provides a statistical approach to passing multiple stage tests and determining acceptance limits in “Establishing Acceptance Limits for Probability of Passing Multiple Stage Tests in Process Validation through a Process Capability Approach.”

“Cleaning Validation: Factors Affecting Recovery Data and Material of Construction Grouping” by Richard J. Forsyth presents an analysis of recovery data taken from a cleaning test sample.

New and Returning Columns
The Autumn 2009 issue of JVT introduces “Device Validation Forum,” coordinated by John E. Lincoln, a consultant with more than 28 years of experience in FDA-regulated industries. This column addresses regulatory requirements, scientific principles, strategies, and approaches associated with medical device validation. The first installment of this column discusses product risk management under ISO 14971:2007.

“Auditor Tales” returns with an account of some of Michael Anisfeld’s true audit experiences involving animals found in the manufacturing environment.

Regular Columns
Scott Sutton, Ph.D., reviews the critical, but often overlooked, protocols for appropriate hand-washing techniques in regards to the pharmaceutical industry in “Microbiology Topics.”

Controls and blind controls are discussed is this issue’s installment of “Analysis and Control of Variation.” Brian K. Nunnally, Ph.D., John McConnell, and Bernard McGarvey review how the use of blind controls can ensure a maintained state of control.
Rizwan Sharnez addresses master soils in relation to how they impact clean-in-place cycle development, new product introductions, and validation of multi-product equipment in “New Perspectives on Cleaning.”

The use of automated tools in computer system compliance is discussed by Jae Burnett in “Computer Validation Forum.”
In “Biotech Processes,” Rachel C. Houp discusses ultrafiltration and diafiltration and the most common membrane used in these downstream processing steps for product concentration and buffer exchange.

Deliang Zhou and Yihong Qui review the application of the biopharmaceutics classification system and the factors affecting oral drug absorption in “Product and Process Design.”

Ed White gives an overview of clean room design and classification in “The Aseptic Core.”

This issue’s installment of “Pharmaceutical Solids,” John F. Bauer presents an overview of the patent process for active pharmaceutical ingredients and the physical properties of drugs.

Editorial Advisory Board
We welcome John M. Hyde of Hyde Engineering + Consulting and Jenna Carslon of Genentech to the journal’s Editorial Advisory Board (EAB).

The editors of JVT are proud to highlight EAB members John E. Lincoln and John McConnell in this issue’s EAB Spotlight.

Electronic Advancements
The Journal of Validation Technology has begun an expansion into the digital world. In 2009, a digital version of the journal was introduced. Our website, gxpandjvt.com, was redesigned and expanded. Also in 2009, we created an e-newsletter with the intent of keeping industry experts up to date on what the journal has to offer.

As always, we encourage readers to give us feedback and to submit papers for publication. Please send your comments and submissions to shaigney@advanstar.com.

Thank you.

ABOUT THE COORDINATING EDITOR
Susan is the coordinating editor for both the Journal of GXP Compliance and the Journal of Validation Technology. Before coming to Advanstar, Susan served as managing editor of Physician’s Money Digest. Susan can be reached by e-mail at shaigney@advanstar.com.