The European Pharmacopeia (Ph. Eur.) is proposing a series of changes in relation to the testing of pyrogens and for bacterial endotoxin. The changes represent the most significant changes to the approach since the Ph. Eur harmonised the bacterial endotoxin test (BET) chapter with the United States and nJapanese pharmacopeia during the early 2000s.
A new article from Tim Sandle for the GMP Review outlines the key changes.
For a copy of the article, please contact Tim Sandle
The reference is:
Posted by Tim Sandle