Pharmeuropa
30.2 carries a revised draft monograph for “Microbiological examination of cell
based preparations”. This is monograph 2.6.27.
In
terms of scope: “The approaches to microbiological examination of cell-based
preparations outlined in this general chapter take into account the
characteristics and limitations of these preparations, in particular their
shelf-life, which may not always allow for completion of conventional
microbiological examination tests before administration to the patient, as well
as the amounts available for testing and sampling-related issues. These
approaches may be applied when the test for sterility, described in general
chapter 2.6.1. Sterility, is required but cannot be performed for technical
reasons or due to the characteristics of the specific cell-based preparation.”
The deadline
for comments is 30th June 2018.
Posted by Dr. Tim Sandle