The Journal of GXP Compliance
Vol. 20, Issue 4, Jul 2016

Tim Sandle
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 cell wall of Gram-negative bacteria. It is pyrogenic and it is a risk to patients who are administered intravenous and intramuscular preparations. The...
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 exclusive lecture, she gives an extensive account of the changing face of the use of statistics in process.
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.
Initiated here with device design and concluding with production controls, this writing will explore the specific recalls, hazardous situations, trends, and possible mitigations related to each of the three root causes that FDA directly correlated to a five year upward trend in medical device recalls.
Christine M. Kielhorn, Ph.D.
For the majority of medical devices, there is no regulatory standard governing the testing and limits of surface particulate contamination. However, there may be risks to a patient receiving a contaminated implantable device. We propose a general approach for testing implantable medical devices for particulates and setting limits for acceptable...
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