ECA Working Groups - Rapid Microbiological Methods

About us

The ECA RMM Working Group was founded on 7 June 2006 at the German Federal Agency for Sera and Vaccines by 11 representatives from the European Pharmaceutical Industry and the German Federal Agency for Sera and Vaccines, the Paul-Ehrlich-Institute (PEI).

During its inaugural meeting the working group reviewed the current situation of RMMs in Europe and defined a work plan.

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 publish Best Practice papers on their website.

Extract of the Activities

2011

• Current survey to the group members about their activities.


• Database increased to 27 systems.


• New course about validation of molecular biological methods


• 4th RMM Conference in Berlin, Germany, in December.

• The Working Group supports EDQM’s survey related to a revision of EP chapter 5.1.6. Around 70 members provide feedback.


• The RMM database now comprises 20 systems.


• Third RMM Conference.

• The group establishes a RMM database and search engine on their website which includes information about different Rapid Micro Methods.


• Second Good Practice Paper: VITEK2 – Microbial Identification.
• Second RMM Conference.