The Journal of GXP Compliance
Vol. 20, Issue 2, Mar 2016

Kelly Waldron
As the principles of quality risk management have become increasingly pervasive in the biopharmaceutical and medical device industries, a point of saturation has been reached with respect to the risk toolkit.
Paul L. Pluta
Every laboratory must become comfortable with being audited. A self-audit conducted internally is an excellent tool for the lab to prepare itself for any audit, identify problems, test execution, and simulate an actual audit experience. Conducting a rigorous self-audit that simulates an actual audit also helps to establish a culture that supports...
Electronic batch record systems (EBR) are increasingly commonplace in pharmaceutical and biotechnology manufacturing environments. EBR systems are used for the automation of the execution of a batch record; they can be interfaced with many different types of systems, equipment, and instruments. Control of the batch record use when manufacturing...
Scott Sutton, Ph.D.
United States Pharmacopeia (USP) <1116> “Microbiological Control and Monitoring of Aseptic Processing Environments” approaches analysis of environmental monitoring data in the aseptic core from a perspective of contamination recovery rate.” This is a more accurate and useful approach when the data consist mainly of “zero”. USP <1116>...
Jerry Lanese
Timothy J. Fields
This column is one of a continuing series in which representatives of the industry and regulatory agencies have an opportunity to express their opinions on current GXP issues. Thank you for your responses to the questions posed in the last issue of the Journal of GXP Compliance. They follow.
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