Quality by Design in Pharmaceuticals allows you to determine Critical Quality Attributes and Critical Process Parameters. Our process Implements QbD for APIs (drug substances) and Drug Products. It is specially adapted to Pharmaceutical Development. It incorporates the best of pharmaceutical Quality Risk Management.

I am Kevin Wall and this is your GMP Minute. Today I will discuss Why I don't do Quality by Design. Many people hear the words "Quality by Design" and cringe. It conjures up images of overly complicated experimental designs, expensive PAT, with a special “QbD” submission Some say“That’s a big pharma thing and not for me.” The truth is ICH principles are for everyone. and they are essential to lower the cost of development. I call my process a “Criticality Analysis”. We identify Critical Quality Attributes and the associated critical variability. Take the data generated during process development and translate that into a risk-based control strategy.
The output grows in detail as you move through development. At each step, the focus narrows onto items that are truly critical to your product and process. It is the basis for specifications and your regulatory submission.
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