JVT Journal Articles
Vol. 22, Issue 6, Dec 2016

The 22nd annual IVT Validation Week meeting was held in San Diego, California, October 18-20, 2016. This meeting comprised sessions on regulatory perspective, technical content, and fundamental principles. Awards including IVT Speaker of the Year, Author of the Year for both Journal of Validation Technology and Journal of GXP Compliance, .and the Kenneth G. Chapman Award recognizing significant contributions in validation...
Allan Marinelli
“Consultant Forum” (CF) provides a vehicle for pharmaceutical industry managers and consultants to share information about their interactions in the daily work environment. This installment includes how a successful and productive relationship is fostered between consultants and their clients.
This discussion addresses the benefits of paperless cleaning validation. Potential inefficiencies with paper-based cleaning validation and corresponding benefits of paperless cleaning validation are discussed. Some of the specific benefits described include reduced cleaning validation cycle time, less cost, improved consistency, integrated...
Paul L. Pluta
This feature provides a forum for validation managers to share information about how they manage the validation function in their facilities. Managing the validation function is a topic that is rarely discussed in professional meetings.
Andreas Bamberg
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Michael Abbass
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Michael Schmidt
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Thomas Nicola
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Thomas Peglow
Are hold times – sometimes considered as lost parameters for cleaning validation (1) – overrated for cleaning validation in manufacturing of small-molecule APIs? This article puts hold times into the context of the typical change-over process in shared facilities for small-molecule APIs and, based on a risk assessment, describes why the risks...
Drew N. Kelner
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Ira S. Krull
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Robert J. Duff
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Tamer Eris
This contribution, because of its length, will appear in approximately, six, consecutive issues of JVT, in unequal installments, every other month, but will use the same references and Figure numbers/captions throughout. Each installment, as for the rest of each Journal issue, will remain available online at the usual website as you receive newer...