ICH Q11 Valued for Bringing Clarity on Starting Materials, Risk Ranking
This article was originally published in The Gold Sheet
Executive Summary
ICH Q11 outlines a set of principles for choosing starting materials, illustrates how a risk assessment can be used to evaluate process changes, and demonstrates how prior knowledge can be used to develop new drug substances, according to members of the working group that wrote the guideline. They also discussed what the guideline does and does not do.