Volume 20 Issue 4 of The Journal of GXP Compliance is in, and it's full of the latest in industry literature, tips, and standards. Featuring articles on medical device validation, implementing new CAPA procedures, bacterial endotoxins, and much more, this new issue is essential reading.
JVT
Aug 31 2016 - 4:17 pm
The MALDI-TOF is a rapid identification system that identifies microorganisms by creating a finger print of highly abundant proteins that is compared to a library of known species to produce an...
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GXP
Aug 23 2016 - 4:00 pm
Bacterial endotoxin presents a risk to several classes of pharmaceutical product, with parenteral products at the greatest risk. Bacterial endotoxin is the lipopolysaccharide (LPS) component of the...
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GXP
Jul 6 2016 - 12:14 pm
Certain pharmaceutical products must be sterile, including injections, ophthalmic preparations, irrigations solutions, and hemodialysis solutions. This is due to the route of administration and in...
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GXP
Jul 20 2016 - 12:43 pm
Marlene Garcia Swider, Ph.D. gives the FDA perspective on the regulatory landscape in an increasingly global manufacturing marketplace. Offering her expert and insider perspective to readers in this...
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GXP
Aug 23 2016 - 4:07 pm
For years the pharmaceutical industry has transitioned from paper-based CAPA processes to electronic systems. CAPA electronic systems provide the ability to manage and control the entire CAPA process.
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