Although bacterial endotoxin remains the most ubiquitous pyrogenic substance in pharmaceutical processing, other microorganisms or microbial toxins can potentially present a pyrogenic risk, along with some chemicals. It is incumbent upon the pharmaceutical manufacturer to assess this. In a new paper, Tim Sandle considers these various risks. The abstract reads:
“This
article considers pyrogens of microbial origin and the theoretical risks they
pose to pharmaceutical products. The focus of the article IS with non-endotoxin
pyrogens. The reasons for this are because of the voluminous content written
about endotoxins and because non-endotoxin pyrogens often receive little
discussion. Despite the low 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.”
The
reference is:
If you are interested in viewing a copy, please contact Tim Sandle.
Posted by Tim Sandle
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