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
Posted by Tim Sandle
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