What is Quality by Design (QbD) and Why Should You Care?

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Is your development or manufacturing operation experiencing cost over-runs and unproductive delays? Do you want to optimize your development dollars and ensure a robust commercial process? You are not alone.

The conventional development process uses an empirical approach that requires continuous end product testing and inspection to determine quality. The processes that create the end product are seen as fixed, averse to change, and focus only on process reproducibility. This approach ignores real-world variability in materials and process controls.

There is a different path. It’s called Quality by Design (QbD). With QbD you will get a proactive approach to product development, potential to reduce FDA queries and review time, and the scientific data to quickly get to the root cause and resolution of any deviation.