The standard gel, chromogenic and turbidimetric Bacterial Endotoxins Test test methods, as described in harmonized USP chapter <85> are validated, meaning that the methodology has been proven and accepted.  However, the QC laboratory can't assume that these validated test methods are suitable for the products under test.  It is incumbent on the laboratory to demonstrate suitability for each material under test through the execution of the compendial "Test for Interfering Factors", also known as Inhibition/Enhancement testing.

While the compendial requirements for this activity are straightforward, the advent of unique formulations and presentations of modern pharmaceutical products may result in test interference that could complicate these otherwise simple tasks.  How does one identify interference?  How does one overcome interference?  How does one structure a suitability study that will meet FDA expectations for new product submissions?  How does one test for and overcome interference when testing medical devices?  Has the retirement of the 1987 LAL Guideline affected how we think about GMP and interference testing?

This conference will be moderated by Karen Z. McCullough, Principal at MMI Associates, a consulting firm specializing in Quality Assurance issues.  She was most recently Senior Director of GMP Compliance at Roche Molecular Systems in Branchburg, NJ. She is acknowledged as a worldwide expert in the field of bacterial endotoxin testing (LAL). She is a Founder, Charter Member and Steering Committee Member for the LAL Users Group. Ms. McCullough's interest is in the convergence of science and compliance in the application of the principles and practices of cGMP to pharmaceutical microbiology. Ms. McCullough holds a B.S. degree in Bacteriology from Rutgers University and a M.S. degree in Molecular Biology from the University of Oregon. She has been involved in LAL testing and pharmaceutical microbiology for over 30 years.