Recent Regulatory Issues Concerning Bacteria Endotoxin Testing

摘要

Within the last two years, there have been developments in two areas of regulatory significance to endotoxin testing. The first concerns changes to the Bacterial Endotoxins Test (BET) chapter in the United States Pharmacopeia (USP). The second is the release by the US Food and Drug Administration (FDA) of a guidance document on pyrogen and endotoxins testing in June of 2012. The Second Supplement to United States Pharmacopoeia (USP) 35 included a few changes to chapter <85>, Bacterial Endotoxins Test (BET). The changes became effective on December 1,2012, and were incorporated into the BET chapter in USP 36 [1], which became effective on May 1, 2013. These changes are described and discussed in turn below.