GXP Journal Articles
Vol. 21, Issue 5, Sep 2017

Many companies will be struggling to determine how to bring their facilities up to code following recent natural disasters. Jeanne Moldenhauer describes one approach to returning these sites to service.
Ivan Soto
This article will discuss data integrity strategies during the data migration of legacy systems. Address data migration challenges and tackle your Data Migration Summary Report.
Fiona O'Sullivan
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Marta Kalska-Zimnicka
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Nuala Calnan
This article provides an overview of a recent academic study undertaken by the Pharmaceutical Regulatory Science Team (PRST) based at Dublin Institute of Technology (DIT), Ireland which involves the implementation of a supply chain maps management program.
Jeanne Moldenhauer
In recent years there has been an increased emphasis by regulatory investigators on the need for a system that encourages senior management involvement in environmental monitoring and sterility assurance programs. For companies manufacturing sterile products, usually this is in the form of some type of Sterility Assurance Oversite Program.
Tim Sandle
This article has reviewed cleaning validation from the microbiological perspective, giving this important (and often neglected) area of pharmaceutical manufacturing attention
Naotaka Hata
Risk assessment in lifecycle management of stability testing is a valuable program for implementation in an organization. Existing risks should be identified, evaluated and controlled by all relevant groups.
Tim Sandle
This article has examined two aspects of culture media preparation: the sterilization of culture media, which is necessary to ensure that culture is not contaminated at the point of use.
Orlando Lopez
Identifying threats and vulnerabilities related to e-records integrity is paramount in today's electronic landscape. Lopez provides a range of strategies so that you can minimize risk in your organization.
Bernard McGarvey
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Jason Marlin
The use of First Principles can greatly enhance our ability to predict system behavior and hence make better decisions.