Conflicts over API Starting Materials Persist Despite ICH Q11 Guide
This article was originally published in The Gold Sheet
API manufacturers in the U.S. and the EU say the ICH Q11 guidance lacks specific direction on when chemicals become starting materials, and as a result there are differing interpretations on designation among regulators. A member of ICH Q11 group advised industry to focus on supply chain, not steps.
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EMA has issued a revised reflection paper that clarifies where in the CTD information on starting materials should go and says that manufacturers can submit certificates of suitability for justifying their use of starting materials under ICH Q11.
There will be no easy answers on starting materials for drug substance manufacture, an ICH working group is finding. Draft guidance that could come later this year will explain the differences between chemicals that are custom-made and those that are commercially available and is expected to outline in more detail the information needed in submissions for starting materials.
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.