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Upcoming ICH Q11 Guide To Clarify What Constitutes Starting Materials

 
• By Joanne S. Eglovitch

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 Draft guidance that could come later this year will explain the differences between chemicals that are custom-made and those that are commercially available and is expected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.

Pharma manufacturing

A question-and-answer guide the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use, or ICH, is developing on the topic of starting materials for drug substance manufacture will provide more detail on just what information applicants need to provide regulators on starting materials and is expected to better clarify the differences between custom-manufactured chemicals and those that are commercially available.

However, the ICH Q11 Q&A guide will stop short of saying how many synthesis steps must occur after chemicals have...

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