FDA Guidance on pyrogens and endotoxin testing

In 2012 the FDA issued their long awaited guidance relating to pyrogen and endotoxin testing. The document has important implications for conducting the LAL test and for assessing products and processes for pyrogenic substances.

As an introduction to the document and to set the context, Tim Sandle has written a review article for the GMP Review.

If you are interested in obtaining a copy, please contact Tim Sandle.

The reference is:

Sandle, T. (2013). FDA Guidance on pyrogens and endotoxin, GMP Review, 12 (2): 7-9

Posted by Tim Sandle