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ICH Demystifies Q11 Guide On Selection Of Starting Materials

Executive Summary

A new Q&A document finalized by the International Council for Harmonisation aims to clarify and harmonize the information that companies should include in their marketing applications on the selection of starting materials for manufacturing drug substances.

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Draft ICH Q11 Q&A Guidance Would Clarify Starting Materials Selection

ICH regulatory members have agreed to request comment on draft Q11 Q&A guidance that is meant to clear up ambiguities on starting materials selection that have fueled debate between industry and regulators for years. The guidance also clarifies the difference between custom-manufactured and commercially available chemicals.

Upcoming ICH Q11 Guide To Clarify What Constitutes Starting Materials

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