Presentation Abstract

The bacterial endotoxin test (BET) has been in use in the pharmaceutical industry for almost 40 years.  As the technology gets more sophisticated and as compliance requirements become more focused, we all need to be assured that we haven't lost sight of the basics of the test.  This miniseries looks at the  "rules" for the routine use of the test including basic calculations, laboratory qualification, analyst qualification, routine assays and monitoring functions. 

In the first webinar, we cover basic calculations and compare the elements of USP <85>, "Bacterial Endotoxin Test" to the provisions of the 1987 FDA Guideline to provide a strategy for laboratory control that meets all requirements.  The second webinar outlines a way to view GMP issues that surround the use of the test including the investigation of OOS results and the use of the test as a tool for raw material screening, process validation and the the monitoring of established processes.

Leaning Objectives

The objectives of this webinar are as follows:

1. Provide an understanding of routine testing including the calculation of endotoxin limits, laboratory qualification and routine assays.
2. Provide a context for the use of the bacterial endotoxins test as a GMP tool including identification of critical control points for process validation and investigation of OOS results.

   Objectives for this webinar:

   • Laboratory Qualification
     • Reagent Qualification (Gel Clot, Quantative Tests)
     • Analyst Qualification
     • Accessory Qualification
   • Calculating Endotoxin Limits
     • Drug, Biologicals
     • Medical Devices

Who Should Attend

Laboratory Analysts, Laboratory Managers, QA Professionals (Auditors, Compliance, Data Review), Manufacturing professionals

Author

Karen Z. McCullough
Principal Consultant
MMI Associates

Author Bio

Karen McCullough is principal consultant at MMI Associates, a consulting firm specializing in Endotoxin and Microbiology testing compliance. Ms. McCullough has over 35 years of experience in the Bacterial Endotoxins Test, and was the first to publish on the use of the LAL test for release of small volume parenterals. She teaches nationally and internationally on endotoxin and microbiological testing. Her current interest is the use of the BET assay as a tool for process control. Other interests include the application of GMP principles to the performance, evaluation and reporting of BET and microbiological test results. She is a charter member and current Chair of the LAL Users' Group. Ms. McCullough is also a member of the United States delegation to TC209, WG02, ISO 14698 (Biocontamination) standard revision, and the Microbiology General Chapters Expert Committee of the United States Pharmacopeia.

Karen McCullough received her BA in Bacteriology from Rutgers University, and her MS in Molecular Biology from the University of Oregon.