Industry, Regulators Divided Over Q11 Definition of API Starting Materials
This article was originally published in The Gold Sheet
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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.