We’ve all heard that quality by design and science/risk-based approaches to pharmaceutical manufacturing require a paradigm shift among industry. Well, that message was reinforced again today at the 3rd Annual Pharmaceutical Technology Conference in Philadelphia, PA.

Christine Moore, acting deputy director of the Office for New Drug Quality Assessment at FDA, said that industry needs to be more willing to share information with regulators. In the past, industry may have been afraid to share details for fear of receiving more questions from the agency. But with the quality initiatives being undertaken by FDA, said Moore, it’s now okay to say, “There are risks with our product.” FDA just wants to know that you can control those risks, she said.

It’s also important to make sure your company has the financial and management support it needs to implement quality by design and quality systems. You have to be able to colloborate with and work with other departments and functions involved in your product’s life cycle, including with other regions in our growing global pharma market, explained Moore.

Gerry Migliaccio, vice president of quality at Pfizer Global Manufacturing, added to Moore’s point. Pfizer, says Migliaccio, has seen first hand all the benefits that can come from using QbD-based manufacturing, including saved cost and time. But to accomplish this, the company had to change its thinking. For example, instead of approaching a problem with corrective action, they focus on continuous improvement throughout the product’s full life cycle. Instead of analyzing proven acceptable ranges, they focus on design space. Instead of working toward blind compliance (i.e., doing what works to obtain regulatory approval), they work toward science- and risk-based compliance, which satisfies the regulators and can be justified scientifically.

This shift in process and thought is not expected overnight but it is taking over the industry. Moore reported that FDA is now receiving more QbD-based applications than it received during the CMC pilot program, which began in 2005. But, added Migliacchio, more culture changes are pending. With fading blockbusters, increasing costs, and additional IP challenges and safety concerns, industry also needs to be rethinking its full supply chain and examining it in ways it never has before. For example, said Migliaccio, Pfizer is now sending its ICH Q8 managers on site to ensure that suppliers are using and following a quality system. The company is also working to monitor pricing and supply gaps and working to help emerging markets that have immature regulatory systems to learn how a process and quality management system should work.

FDA and industry worked together the past several years to draft, approve, and implement the ICH quality guidances, Q8, 9, and 10. But today, much more work is outsourced to markets outside of the ICH region, such as India and China. It’s up to industry, says Migliacchio, to train the companies we outsource to. And if they don’t comply, we have to avoid buying from them or contracting with them. This requires yet another cultural change among pharma. But all of these changes—this re-education if you will—are critical to keeping our supply chains and products safe.