Results of the ECA Survey on Rapid Microbiological Methods - RMMs

GMP News No. 748

GMP News
19 June 2006
 

Results of the ECA Survey on RapidMicrobiological Methods – RMMs

 
ECA would like to thank all colleagues who took part in the survey onRMMs.

We have received 37 filled in questionnaires. The participatingmicrobiologists work for major pharmaceutical companies as well as biotechstart-ups.

The conclusions may be summarised as follows:

  • Many companies plan to introduce RMMs within the next 1-3 years.
  • Clearer regulatory guidance would accelerate introduction.
  • Most companies plan to apply RMMs for Environmental Monitoring.
  • Many companies focus on quantitative methods.
  • Introduction of RMMs often delayed by perceived complexity
    of regulatory approval.
  • Not enough regulatory support to drive a change quickly.
  • A clear regulatory expectation to adopt RMMs would stronglyinfluence
    many companies' thinking.

Apart from the desired clearer regulatory expectations, there are twoother very interesting points. It seems that most companies do not want tostart with RMMs using them for release testing, but want to gain moreexperience with them during less critical applications as environmentalmonitoring. The wish to employ quantitative RMMs sets high requirements onthe validation of these methods.

The outcome of the survey has helped ECA very much to define the workplan for its RMM Working Group which held its inaugural meeting onWednesday, 7th June 2006, at the Paul-Ehrlich-Institut, FederalAgency for Sera and Vaccines. Further information about this group and itsfirst meeting will be published soon via the ECA GMP-News.

  

Microbiology is also the centre of interest in the two following ECAEducation Courses:

Microbiology forNon-Microbiologists,
on 19/20 October in Berlin, Germany and

MicrobialContamination – Corrective Actions, Preventive Actions
on 23/24 November in Vienna, Austria.

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

 

 

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