Pharmaceutical Microbiology Group

MicroSeq Chapter of ECA's RMM Good Practice Guide published for discussion

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One of the goals of ECA's RMM Working Group is to provide documented information for its members about the Pro's and Con's of rapid microbiological methods that are emerging in pharmaceutical QC.

Each chapter of the group's Good Practice Guide will be based on the experiences colleagues have gained during implementing, validating and applying these new methods in the pharmaceutical industry.

The RMM Working Group considers the contributions as "living" documents to which many should contribute.

The first chapter on the MicroSeq system which is used for DNA based microbial identification has been published in the member's area of the RMM Working Group.

"Today we are very glad that we are able to release the first draft chapter of our Good Practice Guide." stated Dr Robert Johnson, recently elected Chairman of the RMM Working Group. "I would like to thank Thomas Mikosch and his colleagues at Centocor for sharing the experiences they have gained with the MicroSeq system. DNA based microbial identification is one of the current key issues in microbiological QC."

The ECA RMM Working Group invites all colleagues - members and non-members - interested in alternative microbiological methods to comment the published paper.

If you would like to contribute to other alternative methods please feel free to contact the group's chairman Dr Robert Johnson. Please send your proposals to rmm@gmp-compliance.org.

Author:
Dr. Ulrich Herber
On behalf of the European Compliance Academy (ECA)

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