With the new draft the US FDA wants to replace the guidance document "Revised Recommendations for the Prevention of Human Immunodeficiency Virus (HIV) Transmission by Blood and Blood Products," issued in 1992. Learn more about the draft Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products.
Measures for contamination control are one of the basic requirements for the manufacturing of medicinal products. Still, contamination control issues got back in the TOP TEN List of 21 CFR 211 Citations. Read more about contamination control as an issue during inspections.
With the new biocidal products regulation from 2013 in-situ generated ozone now also falls into the scope of this directive. Ozone generation systems with a biocide application (such as disinfection of pharma water) thus require an approval after the transitional period expires in the September 2017. The ozone registration group is active for this purpose. Read more about the Ozonization of Pharmaceutical Water and the Biocidal Products Regulation.
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.
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.
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.
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.
