A survey that came out late last year attempted to put an actual figure on the cost of pharma quality problems.  Should make it easier for some of you to get funding for those QbD/PAT/process control projects. We hope. For more, read on.

AMS

Opinions are like noses . . . everybody's got one. (That's the polite version of the maxim, of course.) Never has this been more true than about what to expect in pharma and the life sciences for 2012. We've been trolling the blogs and media outlets, and here is what 13 "experts" are saying about the coming year:

A speaker at last week’s AIChE annual meeting joked about the nitty-gritty, technical nature of the conference’s Quality by Design topical track. QbD talks at some shows are a bit like Las Vegas, he said—more superficial than substantial—whereas at AIChE they were “more like M.I.T.”

I spoke yesterday with Rutgers' Fernando Muzzio, just to catch up on what's happening with the C-SOPS (Center for Structured Organic Particulate Systems) project that his institution, as well as Purdue, NJIT, and PR Mayaguez, are heading up. C-SOPS continues to expand in partners, grants, and technologies that it hopes to license, Muzzio said, and we'll share more on this in the next month or two on PharmaManufacturing.com.

At this week's FDA meeting on PAT and QbD, someone in the audience asked CDER Deputy Director Keith Webber, who had spoken about PAT, QbD, process validation (old vs. new) and real time release vs. end of line testing, whether FDA would ever require PAT.

At this week’s PAT/QbD meeting, sponsored by FDA and the University of Rhode Island’s College of Pharmacy, there was no question that the speaker everyone was waiting to hear from was Ajaz Hussain, former PAT team leader, Sandoz executive and now VP at Philip Morris International.

He burst energetically up to the podium, briefly recapping the history of why PAT was advanced. At the time, he said, FDA was resisting ICH Q8, although Europe and Japan were embracing it.

Last week, Gawayne Mahboubian-Jones, one of the key thought leaders of the pharmaceutical PAT movement, left a position at Optimal Industrial Automation, whose SynTQ software is finding more users in life sciences, to join Philip Morris International as Program Manager, Excellence in Science and Design.

This week, the FDA will lose its most eloquent advocate for process analytical technologies (PAT): Ali Afnan, senior staff fellow at CDER's OPS. who leaves the Agency this Friday to pursue a career in independent consulting. A member of the original PAT team led by Ajaz Hussain, Dr. Afnan had pioneered the use of PAT at AstraZeneca in Europe.

Recent postings in the WSJ blog and elsewhere have asked the troubling question: Does Lean Manufacturing, by definition, lead to quality control problems? Click here for an interesting read. (For something that doesn't require registration, click here.)

Our intrepid contributor Emil Ciurczak is covering this week’s IFPAC 2010 show in Baltimore. What follows is his first installment, a brief summary of pre-conference activities: