The European Pharmacopeia will be changing its approach to bacterial endotoxin test limits. The proposed text for the chapter on “Substances for pharmaceutical use (2034)” reads:
“New
monographs on substances for pharmaceutical use will no longer include the test
for bacterial endotoxins (with possible exceptions); this aspect will now be
covered by this general monograph. In other words, it is the manufacturer’s responsibility
to decide whether or not the requirements for bacterial endotoxins have to be applied
and, if so, to calculate the corresponding limits.”
The
specific wording relating to endotoxin testing states:
The
text also makes reference to finished products:
“Moreover,
as specified in the monographs on Parenteral preparations (0520) and
Preparations for irrigation (1116), these requirements apply to the finished
product. To ensure that a preparation complies with requirements, the manufacturer
may therefore use substances that comply with the test for bacterial endotoxins
and/or demonstrate that the process includes an appropriate procedure for the
removal of bacterial endotoxins. This decision is part of an overall control
strategy that the manufacturer establishes for a preparation, as is the
decision on whether or not to perform the test for bacterial endotoxins at the
level of the substance, in accordance with the General Notices - Demonstration
of compliance
This
General Notice reads:
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