The International Council for Harmonisation (ICH) announced on 8 November the adoption of its Q5A(R2) guideline on viral safety evaluation of biotechnology products as well as a guideline on validating analytical procedures Q2(R2) and a complementary Q14 guideline that aims to harmonize the scientific approaches for analytical method development.
These developments were announced following its 31 October meeting in Prague. All three were adopted as Step 4 documents but have not yet been released on the ICH website. These guidelines now go to regulators for implementation…
