To change the unfavourable competitive situation for the European
pharmaceutical industry the European Compliance Academy (ECA) initiated a
Rapid Microbiological Methods (RMM) Working Group. The group brought
together 11 representatives from the European Pharmaceutical Industry and
the German Federal Agency for Sera and Vaccines, the Paul-Ehrlich-Institute
(PEI); the European authorities will also participate. To accomplish its
goals it will support the industry to increase drug quality and reduce costs
by implementing new technologies as rapidly as possible. On the other side
the group will also provide regulatory agencies sufficient information
within a documented framework on the new technologies to allow a rapid and
simplified decision making process.
In its inaugural meeting in early June at the PEI in Langen, Germany, the
working group reviewed the current situation of RMMs in Europe and defined a
The photo shows from left to right:
Dr Paul Newby, GlaxoSmithKline; Dr Christina Bruntner, Pall Life Sciences;
Dr Robert Johnson, Dialogue; Dr Thomas Lukow, Novartis Behring; Elisabeth
Jander, Pall Life Sciences; Mike Edgington, Director for Regulatory Affairs
(ECA); Dr Thomas Mikosch, Centocor; Dr Klaus Haberer, Compliance Advice and
Services in Microbiological; Dr Thomas Montag, Paul-Ehrlich-Institut; Dr
Sven Deutschmann, Roche Diagnostics; Dr Ulrich Herber, Concept Heidelberg
One of the current issues the group identified is the lack of
standardisation for the submission of RMMs. The group also considers the
integration of certain methods into the European Pharmacopoeia chapter 5.1.6
as critical because it possibly sets a wrong focus on these tests only. In
addition, the use of RMMs for marketed products is discouraged by the Type
II Change effort. The group also voiced concerns about the inappropriate
methods occasionally requested by the authorities - like classical EP
sterility tests for cell therapy products. In general it sees a clear
forward path for using RMMs for new submissions.
To develop a work plan also representing the industry's point of view the
group conducted a survey in one of ECA's Masterclasses and over the internet.
The result representing close to 40 major European pharmaceutical companies
and biotech start-ups across Europe showed that many companies plan on
introducing RMMs in the next 1-3 years, and that most of them want to apply
them for environmental monitoring and to focus on quantitative methods. Most
companies also expressed that there's not enough regulatory support to drive
a change quickly and that a clearer regulatory guidance would accelerate
methods introduction. According to the survey companies also perceive the
approval process as complex, thus delaying introduction. In that respect a
clear expectation for adopting RMMs on the authorities' side would strongly
influence many companies' thinking.
To help both authorities and industry get a better understanding of the
requirements for the introduction of RMMs and to provide them with guidance
based on case studies and available experience, the group will establish a
Best Practice Guide. In two main chapters the guide will concentrate on
traditional drugs and new drugs with their particular aspects and
requirements. "We also want national agencies and inspectorates to be
involved. We'll thus plan on discussing first drafts with representatives
from EMEA, EDQM and national authorities", said Mike Edgington, Director for
Regulatory Affairs, ECA. To share information from the guide with both sides
the ECA will also organise webinars and courses. In addition the group plans
on publishing articles in European pharmaceutical industry publications.
find out more about the Working Group, a GMP Webinar was recorded on 7
July 2006 at the ECA Advisory Board Meeting. You can watch the recorded
Webinar for free. All you need is a fast internet connection, a sound card
in your PC and a Media Player like Windows Media Player or the RealPlayer.
Mike Edgington's presentation.
Further, learn more about current developments in microbiological quality
control in the ECA Webinar Harmonisation
of EP, USP and JP
on 8 November 2006 from 13.30 -15.00 p.m.
Dr. Ulrich Herber
On behalf of the European Compliance Academy (ECA)
If you are interested in contributing to the RMM Working Group, please send
a mail to
info (at) gmp-compliance (dot) org.