QbD Pioneer Afnan to Leave FDA

One of the true thought leaders behind pharma's PAT and Quality by Design movement, Ali Afnan, PhD, has decided to leave his post at FDA. In today's On Pharma blog, Agnes Shanley looks back at Afnan's key role within FDA, and muses about his reasons for moving on.

IFPAC: Analyze This

If you're into PAT and QbD, you'd be hard-pressed to find a trade show with more relevant sessions and productive discussion than the annual IFPAC show. Over the years IFPAC has gotten more and more pharma-centric, and this year's Baltimore event is no different, with GSK's Theodora Kourti getting things started, followed by FDA's Vincent Vilker and Helen Winkle, and then a host of other pharma presenters over the next few days. Click on the preliminary program link on the IFPAC home page.

Looking Ahead to IFPAC

As PAT and QbD have taken hold, IFPAC (the International Forum for Process Analytical Technology) has become an increasingly relevant, and well attended, trade show, and has become increasingly dominated by pharma-focused content. 2010's show begins January 31 in Baltimore, and the agenda is now available online.

ICH Guidelines Show Their Age (and Difficulty)

Throughout this year, our contributing editor Emil Ciurczak has undertaken a series of articles on the need to update ICH guidances--as, he points out, most of them were developed before the PAT/QbD era in pharma. Emil looks at the guidances through a PAT/QbD lens and offers up ways that they'll need revising (when ICH has time to get around to it).

Thus far he has tackled Q2 (R1), Q7A, and Q6A.

His latest analysis is of ICH Q8. We know what you're thinking--Q8 is one of the seminal documents of QbD. True, says Ciurczak: It's not so much that it needs revising, but that it needs ongoing interpretation. Few in the industry read Q8 in full, he notes, and it seems that few interpret it in quite the same way.

If Ciurczak is game, to be continued . . .

--Paul Thomas

For QbD and PAT, Are You Part of the In-Crowd (or Outside Looking In)?

Consultant Jack Carroll (one of our editorial advisors) sent in this commentary on a few things that are holding back PAT and QbD, based upon what he's gleaned from the people attending his training courses. From the attendance at these courses, Carroll says, it's clear that there are currently two factions operating in the QbD/PAT sphere--the mavens and learners. In other words, the in-crowd and the outsiders who are looking in (but may have little financial or corporate support for their initiatives).

Carroll writes: "We find a big disconnect between the PAT and QbD in-crowd and those trying to learn the “art.” The principles are sound, obviously, but the buzz-words are understood differently between the mavens and learners."

--Paul Thomas