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

Overview:

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

The conventional drug 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 resulting in slower time to market, cost over-runs and unproductive delays.

 

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.

 

Author: DPT

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