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In August 2007, ECA's Rapid Microbiological Methods Group issued the first
chapter of its Best Practice Guide on the MicroSeq system which is used for DNA
based microbial identification (see
GMP News from 8 August 2007) The release of the first draft chapter
attracted a lot of attention.
We would like to thank our members for their feedback on the MicroSeq document
written by Thomas Mikosch, Centocor.
Meanwhile we received some written comments which we would like to share with
you.
Dr Hans-Joachim Anders from Novartis, one of the first users of the system in
Europe, sent his remarks on some very relevant issues. Those include cut off
values and validation approaches. The MicroSeq has been in use for routine ID at
Novartis Pharma AG since 2001. At first glance, the acceptance criteria Dr
Anders proposes seem to be less stringent.
Both documents are available in the
RMM Working Group members' area on the ECA
website.
We sincerely hope that the publication of this comment will stimulate more
colleagues to take part in the discussion. Please send your contributions to
rmm@gmp-compliance.org.
If you have not registered for ECA's RMM Working Group yet, you can do so here.
Author:
Dr Ulrich Herber
On behalf of the European Compliance Academy (ECA )
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