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

02 Dec 2016

• By Joanne S. Eglovitch

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.

The regulatory members of the International Council on Harmonization have endorsed additional Q11 guidance that answers some questions on when industry must begin applying good manufacturing practice controls to active pharmaceutical ingredient manufacturing processes.

The US, the EU, Japan and other regulatory members will seek comment on the draft Q11 Q&A guidance in their...