FDA has been advocating process knowledge and understanding for a long time now. The Agency's statements always generate "hear, hear's" and motherhood-and-apple-pie type assents and approvals among industry types...."Of course, we need to understand our processes."

But at times I wonder: Is everyone paying attention? Is anyone? Must full-out production always trump product quality and patient safety?

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.)

Yesterday, I wrote on PharmaQbD.com about a new Morgan Stanley report which suggests that small-molecule drug manufacturers (and to a lesser degree biologics manufacturers) have very little financial incentive to perform their own research and development activities. The old arguments about keeping certain core competencies in-house and managing risks don't hold water anymore, the report says.

Emil Ciurczak continues his reporting from IFPAC in Baltimore:

There were many sessions today, but the one that captivated me and held me in my seat was on imaging. The session, organized by Carl Anderson (Duquesne University) and Steve Hammond (Pfizer), consisted of nine disparate talks tied together by the theme of imaging. Some of the highlights:

Emil Ciurczak reports on Tuesday at IFPAC 2010 in Baltimore:

The talks started in earnest today, with five concurrent sessions. Most were dedicated to pharmaceutical applications, so it was “interesting” to try to cover many of them. One session, in particular, caught my attention: "New Directions and Modeling". Since it made numerous references to chemometrics/multivariate modeling, I had to check it out. In the interest of brevity, I will merely highlight a few of the better talks throughout the day.

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:

Most of you have had it up to your eyeballs in digital requests (take our survey, join our webcast, read this whitepaper!), and so we at Pharmaceutical Manufacturing take our requests seriously. We try to make sure that what we push out to you has purpose and value for you as well.

If you're looking for a model of business/government/academic cooperation in preparing the youth of today for careers in biotechnology and the life sciences, look no further than North Carolina. The state has myriad well-funded, integrated programs at the high school and community-college levels in particular.

The Emerson Global Users Exchange held each fall always has a healthy and engaging life sciences track, with many presenters from within the industry and, as at last year's Exchange, key FDA representatives as well. A call for presentations is now open for this year's event, to be held in San Antonio. Some of the general topic areas you may be interested in, as a presenter or participant:

Process Optimization

Nice article in Financial Times yesterday. It covers water recycling and other efforts underway in pharma, with a quick discussion of overall manufacturing issues. "The middle" of drug manufacturing is under control, the article points out, but the two ends (raw materials and packaging) need to improve.

AMS