Regulators have greater confidence in the quality of drug products developed and manufactured using QbD techniques. And even though the pharma industry is making a great effort to develop processes based on QbD, it needs to update its thinking.

"The area that needs more work is the development of a modern quality strategy that is appropriate for these new technologies, rather than relying on the old checklist approach to control strategies," says Moheb Nasr, director for FDA's Office of New Drug Quality Assessment, in PharmTech.

Another area with room for improvement is aligning existing quality systems with a QbD approach and new technologies, says Nasr. For this task, manufacturers can follow the International Conference on Harmonization's Q10 quality system guidance.

- see the interview

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