GMP News - Aseptic / Microbiology

10.04.13

Harmonisation of Bacterial Endotoxin Testing - ICH guideline Q4B Annex 14

In May 2013, the new ICH Q4B Annex 14 for bacterial endotoxin tests in the ICH regions will become effective. More details can be found here.

more

19.12.12

New Method to Directly Sequence Small Genomes Without Library Preparation

For the first time, researchers sequenced DNA molecules without the need for the standard pre-sequencing workflow known as library preparation. Read more here.

more

21.11.12

FDA-approval for Roche’s nucleic acid based (PCR) Rapid Mycoplasma Test (MycoTOOL® PCR Mycoplasma Detection Kit)

On November 1st, 2012, the MycoTOOL® PCR Mycoplasma Detection Kit-based test from Roche Applied Science was approved by the U.S. Food and Drug Administration (FDA) for release testing of a  Roche biopharmaceutical product. More details here.

more

21.11.12

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.

more

21.11.12

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.

more

20.11.12

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.

more

06.11.12

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.

more

06.11.12

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.

more

19.09.12

EMA raises Concerns regarding Sterility Assurance for DepoCyte and gives Recommendations

The European Medicines Agency has today agreed on a number of precautionary measures to deal with manufacturing deficiencies which could affect the sterility of DepoCyte (cytarabine), an anti-cancer medicine used to treat lymphomatous meningitis. Read more.

more

14.08.12

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.

more

14.08.12

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.

more

14.08.12

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.

more

14.08.12

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.

more

14.08.12

FDA publishes Q&A Guidance on Endotoxin and Pyrogen Testing

In June, the FDA has published a new Question and Answer Guidance for Endotoxin and Pyrogen Testing. It should reflect the current thinking of the agency on that topic. Read more here.

more

14.08.12

New Homepage of ECA's Rapid Microbiological Methods Working Group

The new Rapid Microbiological Working Group website is now online - providing additional information about RMM. More details can be found here.

more

GMP Newsletter

Sign up for the free of charge newsletters.

Sign up now!

GMP Conferences by Topics