Scientists at the U.S. Food and Drug Administration (FDA) have confirmed that plasma specimens are well-suited for detecting the genetic material of hepatitis C virus (HCV) in potential blood donors who are infected with the virus. Read more.
The RMM Working Group's database with Rapid Microbiological Methods Systems is continuously growing. Please see the information on just added and updated systems.
Scott Suttion and Radhakrishna Tirumalai issued a review of the published activities of the Microbiology and Sterility Assurance Expert Committee (MSA EC) of the United States Pharmacopeial Convention (USP) Council of Experts for the 2005–2010 revision cycle. Read more here.
A new rapid microbiology method is being marketed for endotoxin testing. The EndoLISA has been developed by a company called Hyglos and was launched on 1st September 2011. Read on.
The FDA published a scientific poster on "Identifying faster Sterility tests for Biological Products - Regulatory Research Seeks to Reduce the Time Needed to Ensure the Safety of Critical Products". Read more.
In August, the FDA published a Strategic "Plan to Advancing Regulatory Science at FDA". This plan includes statements to amend microbial safety of products with modern microbiological methods. Read more.
Effective since 1 September Geert Verdonk from MSD in Oss/Netherlands and Sandra Gay from bioMérieux in Lyon/France become members of the advisory board of ECA's Rapid Microbiological Methods Working Group. Learn more about the new board members.
Private and governmental quality control laboratories may undergo a standardised quality assessment by the WHO to prove their compliance with the WHO requirements and therefore to be in a position to take over contracts for the UN. Read more here.
The WHO Expert Committee published their Technical Report on specifications for pharmaceutical preparations. In its Annex 2 his report includes the "WHO good practices for pharmaceutical microbiology laboratories". More details can be found here.
