ICH Demystifies Q11 Guide On Selection Of Starting Materials
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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ICH quality reflection paper outlines slate of guidelines to be adopted in near future, as well as a longer-term focus on training and implementation of its guidelines among a growing list of member countries around the world.
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.
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 Draft guidance that could come later this year will explain the differences between chemicals that are custom-made and those that are commercially available and is expected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.