Institute of Validation Technology (IVT)

Volume 20, Issue 4 of the Journal of Validation Technology is hot off the digital press and filled with the latest scholarship, information, and news in the industry. Featured in this issue is an article from the United States PharmacopeialConvention along with articles on computer validation, quality risk management, and device quality

Video
Jun 10 2014 - 6:47 am
For decades, medical technology (med-tech) companies have embarked in process improvement initiatives to enhance product quality while reducing costs. So why are most companies chasing defects...
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GXP
Dec 11 2014 - 2:30 pm
A Column for Discussion of Issues Identified by Readers of the Journal of GXP Compliance and the Current Good Practice for Resolution of the Issues. This column is one of a continuing series in which...
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Article
May 14 2013 - 1:31 pm
The purpose of this supplement is to review the compiled inspectional observations and warning letter citations and learn from the GMP violations made publicly available on the FDA’s website. By...
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Dec 11 2014 - 1:40 pm
Cleanroom contamination can arise from a number of sources. Most contamination within the pharmaceutical facility can be traced to humans working in cleanrooms. The paper discusses staff gowning and...
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JVT
Jan 15 2015 - 3:09 pm
This case study describes a cleaning validation event in which failing results for API residue from a small molecule extended release tablet dosage form were observed. The initial two lots in the...
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