New Orientation for ECA Foundation RMM Working Group

Recommendation

6/7 February 2024

Microbiology for Non-Microbiologists - Live Online Training
Understand the "true" meaning of microbiological findings

The ECA Foundation RMM Working Group was initially founded with the goal to help both authorities and industry get a better understanding of the requirements for the introduction of RMMs and to provide them with guidance. For that purpose it provided current information about the development, implementation and validation of RMM. To move forward to a harmonised thinking, it also initiated literature lists, best practice papers and guideline lists on its website. The group comprised of 11 representatives from the European pharmaceutical industry and the PEI also organised education courses and conferences on RMM and method validation and conducted survey among its members to submit comments to the regulatory authorities.

In the recent past members as well as authorities increasingly contacted the industry-wide well-known RMM Working Group with microbiological topics and questions beyond the scope it had originally defined for itself. Therefore, the ECA and the Group Advisory Board decided to rename it to "Pharmaceutical Microbiology Working Group" and to extend its scope and activities. It is now the Group's goal to concentrate on all relevant microbiological questions in the context of the development and manufacturing of pharmaceutical, biopharmaceutical and combination products. In particular it focuses on current issues like:

• Writing guidance documents for subjects not covered by the authorities - through developing pharmaceutical microbiological best practices (e.g. guideline for deviation handling in non-sterile production facilities and bacterial endotoxin testing).
• Providing information on successful growth media concepts
• Promoting the standardisation for the submission of alternative microbiological methods and pushing the integration of certain RMM methods into the European Pharmacopoeia chapter 5.1.6. 
• Presenting an up-to-date website covering current problems and summarizing relevant publications for pharmaceutical microbiology
• Organising education courses, conferences and trainings on relevant microbiological contents

The ECA Foundation's new Pharmaceutical Microbiology Working Group today counts close to 450 members and is led by Dr Sven Deutschmann, who also already headed the RMM Working Group. He has been with Roche Diagnostics since 1995 and is now Director of the Micro- and Cellbiology QC Department in the Pharma Division. He is also member of several national and international Pharmacopoeial Expert Groups. As member since the RMM Group's foundation back in June 2006 he was appointed as its third Chairman in 2008.

Further members of the Working Group's leadership team are:

• Olivier Guenec, Sartorius, France
• Barbara Gerten, Merck, Germany
• Dr David Roesti, Novartis Pharma, Switzerland
• Dr Ulrich Herber, Charles River, Germany
• Dr Björn Breth, bioMérieux, Germany
• Dr Marcel Goverde, MGP Consulting, Switzerland
• Marja Claassen, MSD, The Netherlands

Moreover, two representatives from authorities support the Working Group in the ECA Foundation's Independent Authority Advisory Board (IAB):

• Priv.-Doz. Dr Claudius Micha Nübling, World Health Organization (WHO), Geneva, Switzerland
• Dr Isabelle Bekeredjian-Ding, Paul-Ehrlich-Institut (German Federal Institute for Vaccines and Biomedicines), Germany