BRIEFING

 〈1085〉 Guidelines on the Endotoxins Test. This proposal is based on the version of the chapter official as of December 1, 2020. The Microbiology Expert Committee is proposing a revision to this chapter with updated best practices, including:

1. Revise the chapter title from "Guidelines on the Endotoxins Test" to "Guidelines on Tests for Endotoxins".

2. Revise the Background section to align terminology.

3. Update the Endotoxins section and move the edited content to Background.

4. Provide more information and clarify:

   • Preparatory Requirements, including RSE to CSE calibration

   • Screening and Qualification of Labware, as well as equipment and instruments used for BET

   • Calculating limits for endotoxins for products, preparations, substances, and medical devices

   • Product positive control (PPC) criteria

   • Test interferences, including an updated Table 3 that specifies whether they apply to all reagents or only LAL reagents

   • Routine Testing, providing more guidance on sampling raw materials, finished products, and pooling

   • Calculation of Endotoxin Content and updated guidance on OOS investigations

   • Updated Standard Curve Control to include fluorescence tests and included information on the use of archived curves

5. Update the document to include recombinant reagents, and revise terminology so that both lysate and recombinant reagents are included.

6. Provide a reference to the General Notices for alternative tests.

7. Remove the Glossary; definitions are now located in Microbiological Chapters—Glossary 〈1117.1〉.

 Additionally, minor editorial changes have been made to update the chapter to current USP style.

 (GCM: L. Furr)

 Case ID–SUB-490