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.
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.
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.
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.
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.
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.)