Quality by Design

'Quality by Design' (QbD) is one of a series of programs from the FDA that is part of their 'Quality in the 21st Century' initiative. In summary, this program emphasizes the fact that quality cannot be tested into anything, it has to be built in.

In this particular instance the built-in quality is the understanding of the formulation and process limits that can assure the finished medicinal product will consistently deliver the drug in the correct amount, at the correct rate, over the shelf-life of the product. In practice, if one is able to establish the 'Design Space' for the product, there may be significant post approval regulatory savings in terms of supplemental filings. When executed properly, QbD is the foundation for robust medicinal products, and Process Analytical Technologies (PAT).

QbD starts with preformulation, since this underpins all successful formulation projects. While much of QbD implementation will properly focus on scale-up and process development, and probably commercial scale manufacture, it is important to understand that there are elements of QbD that are relevant to formulation and process design. QbD can be regarded as 'Good Development Practice'; good decisions based on good science.

You can watch an interview on YouTube that Chris gave at the USP International Excipients Workshop 2009 responding to the question of the challenges that the pharmaceutical industry faces with the introduction of Quality by Design.


FinnBrit Consulting can advise on how to implement an effective QbD strategy for a particular project.

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