From the Editor: Think Like An Engineer

Chemists, pharmacists and biologists need to bridge the divide.

By Agnes Shanley, Editor in Chief

At a recent pharmaceutical industry meeting, a speaker referred several times to S88, the standard for open process control that is changing the way more pharmaceutical manufacturing plants are designed and operated. After the applause died down and hands went up for questions, one brave soul asked, “What is S88?”

At least he asked! A good percentage of our readers are engineers, and up on such things. But it seems that many nonengineers working in the industry aren’t aware of the engineering initiatives that are about to transform drug manufacturing. Despite nearly incessant hype about Process Analytical Technologies (PAT), a surprising number of people working for pharmaceutical companies don’t even know what it is.

That a chemist working in pharmaceutical quality control today wouldn’t know about PAT is unbelievable. But why should he or she care about S88, COPA, or Fieldbus? Or concepts like “metadata”? The answer is simple: In the future, quality will depend more closely, as it does in other industries, on process control, instrumentation and mathematical modeling. Like it or not, nonengineers, the era of the geek is dawning.

Your eyes may glaze over at all the acronyms, but the concepts behind them are as beautiful as any work of art. Consider the work of the New Sampling and Sensor Initiative (NeSSI), which will miniaturize analytical devices, empowering the lab. Or take the electronic notebooks and e-compliance technology that some quality and R&D professionals are already using to eliminate recordkeeping drudgery. And good news! This technology will soon be applied to batch recordkeeping at a plant near you.

We all know the reasons why — fear of regulatory change, validation concerns — but process control remains under-explored in the pharmaceutical industry today. Control experts tell us that most drug manufacturers aren’t using over 90% of the capabilities resident in the advanced sensors in their plants. One also wonders: are they utilizing all the expertise of their engineers?

In this issue, we salute the engineers whose efforts promise to move drug manufacturing from three to six sigma levels of quality over the next few years. In our cover story, Ajaz Hussain, Deputy Director of FDA’s CDER, discusses how ASTM’s engineering standards and ICH will help move pharmaceutical manufacturing to a “desired state,” where a science-based framework drives quality decision making. Other articles focus on S88 and how it is transforming batch manufacturing, CIP, and even WFI operations at companies including Sanofi-Aventis, Pfizer, and BMS.

Engineering is such a revered profession in the rest of the world that I’ve never understood why it is so undervalued in the U.S. I discovered engineering after studying liberal arts. Growing up in a musical household, opera and literature had topped the agenda 24/7. Then came an epiphany in college when I saw an integral sign in someone else’s text book and had absolutely no idea what it was. I finally realized that, whether Domingo took the high C or opted for the B-flat that night, there was an ocean of knowledge out there that I knew absolutely nothing about. And engineers were navigating that ocean every day and using to solve important problems, quietly and without fanfare.

If you are an engineer, you have reason to be proud. And if you’re not an engineer, you’ll be doing your career, and your company, a real service by delving behind the acronyms and reading up on what engineers are doing. Not only is it interesting, it may directly affect you, and sooner than you think. And it can only help you work more effectively with the engineers on your teams.



Editor’s Note: Our magazine has one of the most talented art directors around, Steve Herner, whose work has just won three ASBPE awards for graphic design. The June issue’s cover pays respectful homage to the ideals of Buddhism. While all of the world’s great religions aspire to help humans achieve enlightenment, Buddhism has articulated, perhaps more clearly than any, the need to aspire to higher states of knowledge, a perfect symbol for the industry’s goal of reaching the “desired state.” We were shocked to hear that our cover graphics offended some. What is your opinion? Please let me know (ashanley@putman.net).

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