The FDA just published their final Guidance for Industry Pyrogen and Endotoxin Testing: Questions and Answers. FDA has determined that previously published USP and AAMI documents describing methods and calculation of pyrogen and endotoxin testing limits provide industry with appropriate information. However, because the compendial chapters and standards do not address certain regulatory perspectives, FDA is providing supplemental information in this new Guidance to provide current thinking for FDA regulated products. Several of the representative topics are listed below to include:
1. How do I establish a sampling plan for in-process testing and finished product release?
2. When is retesting appropriate?
3. Is sample storage and handling important
4. Can finished product samples for analysis of bacterial endotoxins be pooled into a composite sample prior to analysis?
5. May a firm use alternative assays to those in the USP for a compendial article?
6. What is the best process for transitioning from one alternate bacterial endotoxins test (BET) method to another?
7. What happened to the endotoxins limit table in Appendix E of the 1987 Guidance?
8. How can Quality by Design concepts support endotoxins limits?
9. When is the USP Chapter <151> Pyrogenicity Test (the rabbit pyrogen test) appropriate?
The entire Guidance for Industry may be found at:
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