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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.
Please click here to
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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