Input for ECA's RMM Best Practice Guide Chapter from Leading Industry Expert

GMP News
2 November 2007
 

Input for ECA's RMM Best Practice Guide Chapter from Leading Industry Expert

 
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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