Pharmaceutical Microbiology Group

Results of the ECA Survey on Rapid Microbiological Methods RMMs

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

We have received 37 filled in questionnaires. The participating microbiologists work for major pharmaceutical companies as well as biotech start-ups.

Read the detailed results.

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 strongly influence
    many companies' thinking.

Apart from the desired clearer regulatory expectations, there are two other very interesting points. It seems that most companies do not want to start with RMMs using them for release testing, but want to gain more experience with them during less critical applications as environmental monitoring. The wish to employ quantitative RMMs sets high requirements on the validation of these methods.

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

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

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