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.
In the latest edition of the Federal Register, FDA announced proposed changes in the requirements on sterility testing of biological products. Get the details here.
