Blogs

PAT Won't Be Mandated (But Don't Look for Any New Incentives Either): CDER Deputy Director Webber

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.

"Ajaz the Avenger" on the Need for Unity: For PAT and QbD, Pharma Must Learn from Bioprocessing

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.

Big Tobacco and the PAT Brain Drain

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.

Ali Afnan to Leave FDA

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...

Dialogue with FDA: Can You Speak the Language?

Ever get stuck behind a loud bore on an airplane? I had that misfortune last week. Eventually tuned him out, but couldn’t help but pity his quiet seat-mate, who didn’t know a peptide from a Pepsi, as he got sucked deeper and deeper into a one-sided verbal black hole,...

Raman and the Quest for a Standard Spectroscopic Library

Raman spectroscopy, particularly hand-held Raman, is gaining favor as a pharmaceutical QC tool, given its convenience, speed and accuracy.  A number of presentations at USP’s annual science meeting in Toronto discussed how hand-held Raman is being successfully used as part of pharmaceutical anticounterfeiting toolkits.

Excipient Inspection and Standard-Setting: A New Role for a High-Level FDA Alumnus?

At the USP science meeting in Toronto, I met Janeen Skutnik of Pfizer, currently chair of IPEC Americas, and former IPEC chair, Colorcon's David Schonecker. (Also met incoming chair,  William Dale Carter of JM Huber, who will start his new role next year).

FDA Commissioner Hamburg on Enforcement: "My Own Naivete May Move Things Forward"

FDA Commissioner Margaret Hamburg, whose speech on enforcement objectives and public health was just videocast live by the FDLI., appears  to be the kind of leader this Agency has needed for a long time, one who communicates equally effectively to the public, politicians, industry and to colleagues within  the Agency.

Will PAT Become Mandatory?

Even though we now have incontrovertible evidence that nobody reads blogs anymore, couldn't condense this one into a chirp or tweet. Please bear with me.