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.
New FDA Interim Guidance for Human Drug Compounding Outsourcing Facilities
Compounding pharmacies in the US haven't been inspected by the FDA over the past years. For the first time, after a number of serious incidents which caused death, the FDA has tried to establish cGMP requirements for the manufacturers of outsourced drug compounding in an interim guidance for Industry. Read more details here.
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.
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.
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.
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.
USP Draft of a newly proposed Chapter – <1115> Bioburden Control of Nonsterile Drug Substances and Products
In the Pharmacopoeial Forum 39(4), USP published the draft of the long time expected chapter on Bioburden Control of Nonsterile Drug Substances and Products. Read more here.
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.
EMA publishes ICH Q4B Annex 14 - Bacterial Endotoxin Tests
The European Medicines Agency (EMA) published ICH guideline Q4B Annex 14 to note for evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on bacterial endotoxins tests". Read more.
With this guidance, the FDA addresses blood establishments that collect Whole Blood and blood components for transfusion or for further manufacture. Read on.
FDA - Testing HCT/P Donors for Relevant Communicable Disease Agents and Diseases
Related to the HCT/Pdonor testing, the FDA/CBER has updated their page with licensed donor screening tests and further information about safety for relevant communicable disease agents and diseases. Read more.
The questions "For an aseptically produced product, where should bioburden monitoring take place?" and "What is the maximum accepted bioburden level?" are answered by EMA on its questions and answers page. Read more.