Growing Freedom, Growing Responsibility

Conference season struck with the last of the year's hurricanes, so it's been another month in motion, with great excitement and great things happening in Philadelphia and Nashville, Miami and Madrid.

Douglas McCormick

What makes the travel—and the rapid accumulation of unwanted airport time—worth it, of course, is the people we meet when we land. And everywhere I've gone lately, I've found people with a passion for quality that goes beyond strict self-interest and professional requirements. Certainly, they are concerned about economic impacts on their companies and career impacts on themselves. But, I saw, too, an over-riding concern for the welfare of the patient and a conviction that our products help people live better lives.

I've also seen the way new ideas about defining quality and designing processes are percolating through the industry. We've written about these developments a lot over the past year (For more detail on the cases-in-point mentioned here, please see this month's "In the Field" reports and our most recent online newsletters, archived at www.pharmtech.com under the menu selections for ePT: the Weekly Newsletter and ePT Live, which includes Pharmaceutical Technology's very first onsite coverage of a major meeting). It seems, however, that the brightly colored, disconnected bits are beginning to fall into place, making a coherent mosaic of the future.

At the Institute of Validation Technology's Validation Week conference in Philadelphia, PA, US Food and Drug Administration Guidance and Policy Team leader Kristen Evans spoke at length about FDA's emerging science- and risk-based approach to quality, underlining once again that dynamic controls based on solid process understanding are replacing 1980s-vintage cookbook approaches. As Pharmaceutical Technology has reported consistently, this change in thinking is both exciting and unsettling, and the human beings involved—not only in the industry, but also among the varied cultures inside the FDA—need some time to get used to it. We're in a period of dynamic change, and things will be in flux for a while.

Down in Miami, pharmaceutical compliance professionals gathered for the Validation and Compliance Summit (part of Worldwide Business Research's Pharmaceutical Manufacturing 2005 conference). The city was still digging out and sweeping up after Hurricane Wilma the week before, and storm damage was a mainstay of conversation (the 45-story office building across from the conference hotel had no intact glass above the 30th floor). But the conferees were also abuzz about the previous week's decision by the US District Court for the District of Utah, which found in favor of device-maker Utah Medical Products (Midvale, UT, www.utahmed.com) in its dispute over FDA's interpretation of what constitutes compliance with Quality System Regulation (QSR, 21 CFR 820).

According to the decision handed down by District Court Judge Bruce S. Jenkins:

"The fact that the road chosen by Utah Medical may be different in degree than that thought to be appropriate by a regulator, does not mean that it is wrong, or in violation of the regulations... "

Again, this principle seems to open up broad new options for attaining quality, and threatens to sweep away the old, comfortable regulatory prescriptions.

And in Nashville, at the American Association of Pharmaceutical Scientists annual meeting, we found again that new, dynamic notions of quality assurance were embedded everywhere. Continuous manufacturing—common in other process industries but non-existent in pharmaceuticals—goes hand-in-hand with quality-by-design, process understanding, and process analytical technologies (PAT). Industry scientists linked continuous processing with a host of benefits ranging from tighter product uniformity to lower costs, and an FDA representative showed how they all fit together to make up the future regulatory "desired state" of "a maximally efficient, agile, flexible pharmaceutical manufacturing sector that reliably produces high-quality drug products without extensive regulatory oversight." (With all the discussion of PAT, continuous processes, and real-time product release, it's worth noting that FDA has yet to receive its first continuous processing application, and has okayed only one real-time release application.)

And time after time, the folks I spoke with, on both sides of the FDA–Industry divide, emphasized this: in this time of change, the key to progress, perhaps even survival, is communication. Because many pharmaceutical manufacturers regard the periodic discussions with the FDA with the same optimism, joy, and openness with which any of us would greet an opportunity to sit down with the Internal Revenue Service, this may be the greatest challenge of all. We have an abiding dread that anything we say may be taken down and used in evidence against us, and we may not have built up the faith that frank communication will build trust and help secure the degree of freedom that FDA theoreticians now offer and the new paradigms demand.

Douglas McCormick is editor in chief of Pharmaceutical Technology, dmccormick@advanstar.com