Saturday, 2 June 2018

Microbiological examination of cell based preparations


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.

See: Pharmeuropa (http://pharmeuropa.edqm.eu/home/)

Posted by Dr. Tim Sandle

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