News

New guideline for DNA Sequences could prevent erroneous Data

A international team of researchers, with it’s core at the University of Gothenburg, Sweden, has prepared a guide to assist the scientific community in the quality control process. Find out more.

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Revision of USP 1223 - current Status

The Vice-Chair of the USP General Chapters – Microbiology Expert Committee, Tony Cundell, recently provided an update to the chapter’s revision process and what we should see when the draft is published in a future issue of the Pharmacopeial Forum. Read more.

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Rapid Micro Biosystems announces Availability of Growth Direct System

New applications should improve the efficiency of microbial quality control processes while significantly reducing the time-to-result. More details can be found here.

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EMA Assessment Report - on detected genomic fragments from endogenous and adventitious viral agents in live attenuated vaccines

The EMA/CHMP published an assessment report - on detected genomic fragments from endogenous and adventitious viral agents in live attenuated vaccines. More details can be found here.

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Literature and publications list are updated with 11 publications

The new literature and publication list on the RMM Group website was completed with new interesting reports and publications. Read more here.

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RMM database updated with new systems

The Rapid Microbiological Methods database in the member area of our working group was updated with 4 new systems, e.g. for sterility testing and Endotoxin detection. More details can be found here.

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Dr. Claudius Micha Nübling becomes Member of the RMM Group Advisory Board

Dr Claudius Micha Nübling from the Paul-Ehrlich-Institut became member of the RMM Group Advisory Board. He will follow our longstanding Member Dr Thomas Montag. Read more here.

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New Additions to the Literature List on ECA's RMM Website

The ECA Rapid Microbiological Methods working Group added new reports and articles to the literature list on its website . More can be found here.

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Rapid Methods - CBER's Strategic Plan for Regulatory Science and Research

The FDA's CBER published their strategic plan for regulatory science and research 2012 -2016. A possible further step for implementation of modern microbiological methods? Read more.

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More Flexibility in Sterility Testing of biologic Products – FDA Amendments

Within FDA's scope - to review and, as necessary, update biologics regulations, to keep pace with technological developments and to boost regulatory science, the US authority published amendments to the sterility testing rule. Read more about the background and contents.

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