The ECA Pharmaceutical Microbiology Working Group concentrates on all relevant microbiological questions in the context of the development and manufacturing of pharmaceutical, biopharmaceutical and combination products.
During the last 10 years, the group more and more became the preferential contact point for all microbiological topics, questions from members as well as for requests from authorities. Therefore, the ECA and the Group Advisory Board decided in 2015 to rename the group to Pharmaceutical Microbiology Working Group and to extend its scope and activities. It is now the group's goal to provide advice with regard to all different subjects in pharmaceutical microbiology.
The current issues of the group are:
- Giving guidance in pharmaceutical microbiological best practices by writing guidance documents for subjects not covered by the authorities (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 group was founded as Rapid Microbiological Methods (RMM) Working Group on 7 June 2006 at the Paul-Ehrlich-Institut (PEI - the German Federal Agency for Vaccines and Biomedicines) by 11 representatives from the European pharmaceutical industry and the PEI. The working group reviewed the current situation of RMM in Europe. In the following years it supported group members with current information about the development, implementation and validation of RMM. To move forward to a harmonised thinking, the group provided literature lists, best practice papers and guideline lists on its website. It further organised education courses and conferences on RMM and method validation. Moreover, the group submitted member comments to the regulatory authorities.