News

RMM Homepage - Update and new Structure of Literature List

During the first months of 2014, the literature part of the RMM homepage was re-structured. More about the new structure of the subpages with the regulatory background, literature reports and articles about the different types of Rapid Microbiological Methods can be found here.

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Revision of the EU GMP Annex 15 for Qualification and Validation published

The EU Commission has published the revision of the GMP Annex 15. Compared to the currently valid version the document has been revised extensively. Read more about the most important changes.

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New system added - Rapid Microbiological Methods Database updated

The Rapid Microbiological Methods database in the member area of our working group was once again updated with new systems. Find out more.

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NAT Testing of West Nile Virus from Human Cells and Tissues

As a part of their continuous review of new data related to West Nile Virus, the FDA published a Draft Guidance for Industry: Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). Read more.

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FDA publishes ICH Q4B Annex 14 for Interchangeable Endotoxin Testing between ICH Regions

The US FDA adopted the "ICH Guideline Q4B Annex 14 to note for evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on bacterial endotoxins tests - general chapter". Read more.

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PDA TR33 Evaluation, Validation and Implementation of Alternative and Rapid Microbiological Methods

The Parenteral Drug Association published the revised Technical Report No. 33 on Alternative and Rapid Microbiological Methods. Read more here.

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U.S. FDA Clearance for Mass Spectrometry

bioMérieux announces U.S. FDA Clearance for VITEK® MS, a revolutionary technology which reduces microbial identification from days to minutes. Further details can be found here.

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Rapid Microbio Methods Database updated with new systems

The Rapid Microbiological Methods database in the member area of our working group was updated with 3 new systems. For more information please see this news.

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Use of Nucleic Acid Tests

With this guidance, the FDA addresses blood establishments that collect Whole Blood and blood components for transfusion or for further manufacture. Read on.

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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.

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