Quality by Design — A Useful Tool or Death by Statisitics?


Incognito considers the usefulness and scope of the Quality by Design approach to HPLC method development through a question and answer format.

I have to say I’m a fan of statistics if it helps me to better understand or control my analyses. I am not a fan of statistics or process management methods that are imposed to comply with the latest process control or manufacturing quality initiatives and lend nothing but bureaucracy to chemical analysis.

Quality by design (QbD), as a method of process modelling and control may, without more careful consideration, fall into the second of these categories, however, I wanted to find out more about the principles behind the philosophy before consigning it to the ‘death by statistics’ draw. Further, the FDA are recommending this approach to chromatographic method development, validation and on-going process control - always a compelling reason to take a closer look!

In the following discussion, I have attempted to answer questions elicited from industry colleagues to better define the scope, principles and usefulness of the QbD approach to chromatographic method development. If there are any factual discrepancies within this piece or you hold an alternative view, I strongly recommend that you contact me at [email protected]

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