Monday, 22 June 2015

Non-endotoxin Microbial Pyrogens


Pyrogens of microbial origin need to be considered in relation to the risks they pose to pharmaceutical products. Despite the low theoretical risk posed by non-endotoxin pyrogens, questions of their occurrence and risks are sometimes raised by regulators through inspections and by assessors during license changes and submissions. When such questions arise the pharmaceutical manufacturer is often called upon to undertake a risk assessment. Some of the information outlined within this article could be helpful in developing such an assessment.

With this regard, Tim Sandle has written an article for the Journal of GXP Compliance.

The reference is:

Sandle, T. (2015) Assessing Non-endotoxin Microbial Pyrogens in Relation in Pharmaceutical Processing, Journal of GXP Compliance, Vol. 19, Issue 1, 1-10

For details see: IVT.

If you are interested in reviewing this, please contact Tim Sandle.

Posted by Tim Sandle