Achieving Quality by Design

Packagers can step up quality and address inevitable variations through a better-informed product development process.

Product quality has been suffering as of late, with recalls of FDA-regulated products skyrocketing. Recalls for products overseen by all FDA centers totaled 9288 in 2011, compared with 4266 in 2006.

Speakers at the Pharmapack North America conference in May argued that product quality could be better ensured through better product and process understanding and better risk management.

Interestingly, current pharmaceutical packaging development efforts may be taking “a shotgun approach that leads to overpackaging,” which can be “inherently inefficient,” explained Peter Schmitt, managing director of Montesino Associates, in “Achieving Quality by Design.”

Schmitt compared the current approach, which he calls “Quality by Testing,” with an approach he says FDA has shown considerable interest in, “Quality by Design,” as defined in ICH Q8.

In “QbT,” packaging engineers “test to document quality, investigate out-of-specification materials and products, and avoid risk at all costs,” Schmitt explained.

Conversely, QbD entails “designing quality into the package from the beginning and continually improving processes while managing risk.”

To do so, engineers must identify up front what is needed to maintain a product’s given “critical quality attributes” and determine the “edge of failure” to understand the required range of process control.

“Under a QbD approach, closure and container systems are designed to meet those critical attributes and continually evaluated and updated over time,” Schmitt said. “There is a threshold for a step change, if needed.”

And changes happen frequently in packaging materials, despite industry’s attempts to prevent them, Schmitt said. “We pretend things don’t change. But just as the earth is rotating 920 mph today here in Philadelphia as I speak yet we do not feel it, change continues to happen under our feet in the industry, even though we do not feel it,” he told the Pharmapack North America audience.

Through QbD, change can be managed, and perhaps even appreciated. “If we really understand what we are doing, we can reduce the need for restrictive tolerances in parameters,” Schmitt added. “If you understand the edge of failure, you don’t have to have perfect control over everything. But you do need to know exactly when pressure or temperature is too high or too low, for instance.”

Schmitt explained that engineers can often determine the necessary process ranges through simulations.

Successful risk management requires an understanding of three spaces: “control, design, and knowledge,” said Schmitt. “If you are working within the design space, nothing can go wrong. It can be argued that there is regulatory flexibility, so modifications may not be considered ‘changes’,” he said. “I believe that the design space will become part of regulatory filings in the future.”
“QbD is not a burden, but a relief!” said Schmitt. “It allows for continuous learning.”

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