ICH Q14 101: Applying AQbD to CMC for Regulatory Success

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q14 is a new quality document describing analytical procedure development. Previously, no ICH guidance specifically covered analytical method development, resulting in a lack of clarity on what to present to regulators. It was difficult to present a scientific basis for methods and justify post-approval changes. ICH Q14 has been issued in draft form at the time of writing this e-book.