Without Fanfare or Formal Announcement, ICH Q11 Now Available for Comment

The release of ICH Q11 has been anticipated for some time now. The purpose of Q11 is to take the Quality by Design concepts mapped out in ICH Q8, Q9, and Q10 and apply them more clearly and specifically to the development and manufacture of drug substances (as opposed to drug products). And so the release of the draft document is a cause for fanfare.

And yet when the Expert Working Group overseeing Q11 signed off on the draft last week, no major announcement was made. This past Monday, at DIA 2011 in Chicago, I sat in on a session that featured two key figures from the ICH working groups--FDA's Moheb Nasr and Betsy Fritschel of Johnson & Johnson. In his talk, Nasr mentioned almost as an aside that, oh, by the way, the draft document is now available. Fritschel confirmed this news in her talk. Strangely, the ICH document appears first on EMA's website but not yet on the ICH site (that I can find).

For a bit of history and a look ahead, here is a summary of Fritschel's talk about the origins of Q11, its inherent flaws, and when it might be finalized.

--Paul Thomas