News

Ph.Eur Chapter 2.6.8. Pyrogens Revision open for Comments

In Pharmeuropa issue 26.4, the EDQM published the draft of the revision of chapter 2.6.8. Pyrogens. It is open for comments until 31. December 2014. Read more.

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Question and Answers to Endotoxin Masking and Low Endotoxin Recovery (LER)

Following ECA's webinar on Endotoxin Masking, the speaker summarized the questions related to masking and LER in a Q&A document. Read more here.

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EDQM revises 5.1.10. Guidelines for using the Test for Bacterial Endotoxins

Recently, the EDQM published the revision of 5.1.10. "Guidelines for Using the Test for Bacterial Endotoxins" and added alternative methods like recombinant factorC. More details can be found here.

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RMM Working Group announces Changes on its Board

Due to changes in their careers, to professional re-orientation or due to retirement, four of the RMM board members will step out from their RMM activities and leave the board of the group. Read more about the new members here.

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Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices

FDA published a draft Guideline on Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices. It is a result of FDAs activities to reduce the outbreaks of Toxic Anterior Segment Syndrome (TASS). Read more here.

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Draft USP Chapter 1223 Validation of Alternative Microbiological Methods published

The USP published the draft of the revised chapter 1223 "Validation of Alternative Microbiologiocal Methods." Read more.

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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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