this needs to happen now is that the science that’s done in process development needs to be so solid and so well communicated that it forms the basis for the process in commercial operations,” says Neway. “And it’s a continuum. You don’t suddenly do something new because you’re in commercial manufacturing. You draw on the science that was done up to that moment.”

Further, the QbD approach encourages continuous feedback as well as feedforward of pertinent information. “If process development comes up with a process, and manufacturing operations learns something about it when they’re running it on a commercial scale, then that information has to come back and factor into what you do on the next cycle for the next drug that’s in a similar class,” Neway observes.

Aegis offers a software suite called Discoverant that is designed to facilitate the bi-directional flow of information needed throughout a drug product lifecycle. The package integrates pharma industry-specific analytics together with data connectivity technology that can provide users with real-time access to data from multiple systems and sources. This includes even the paper records that remain common throughout the pharma industry, through a Discoverant component designed to efficiently capture that data.

Despite what some might call a slow start for the pharma industry in adopting new QbD approaches, the FDA’s Nasr says he has been pleased with the progress to date.

Today, there is general agreement around the industry that the QbD approach is a better regulatory approach than that of the past, and that it makes good business sense, Nasr says. When the FDA began its big push for the QbD approach starting in 2004, questions from industry centered on what QbD meant and whether or not it was needed, Nasr observes. But today, he says, the questions center on how to go about implementing QbD for a particular drug product, delivery system or manufacturing process. Now, “its more about how do I do it, rather than is it needed or not,” Nasr says. “So I would consider that big progress.”

Bits and pieces

The FDA official says that even prior to the FDA launch of the QbD initiative, some pharma companies had already been using “bits and pieces” of the approach. This became evident beginning in 2005, when Nasr’s Group launched a pilot program by which it encouraged companies to submit QbD information they had, and to share their QbD approaches related to the Chemistry Manufacturing and Controls, or CMC, portion of new drug applications. That program, which ended in 2008, ultimately resulted in a dozen applications from major pharmaceutical companies, 11 of which have already been approved, says Nasr. “So we do have products in the market now that were developed and evaluated based on Quality by Design approaches.”

While these products were not necessarily developed using the “complete systematic approach” that QbD calls out, the Agency has since developed a process to encourage companies to continue the QbD approach throughout their entire new product submissions. QbD-based submissions today are not yet the norm, Nasr concedes. But the number of applications that include QbD principles today is on the rise, he says.

To listen to a Podcast of the complete interview with the FDA’s Dr. Moheb Nasr, please visit www.automationworld.com/podcast-5545.

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