After five years, working group members of the International Conference on Harmonization have adopted its Q11 guideline on drug substance development and manufacture, which advances QbD principles for drug substance development, especially for biotechnology products, endorses the use of prior knowledge, and establishes a harmonized definition for starting materials. Even though not everyone is happy with this definition, ICH members say that a harmonized definition is better than a non-harmonized one.

It’s time to comment on ICH Q11

A guideline the International Conference on Harmonization will soon release on drug substance quality attempts to better define regulators’ expectations for drug substance development and to better harmonize these expectations among the ICH regions within the quality by design framework.