Quality by Design is decried as a theoretical, academic and complex system. In the meantime, it is set as a standard in the US pharmaceutical industry. In Europe, the concept is slowly accepted. Fact is: Development based on QbD will be safer, faster and more agile.
The term Quality by Design (QbD) is less than ten years old in the pharmaceutical industry but it gained a lot of attention especially from companies supplying the US market because FDA has defined the concept as part of the “desired state” of where pharmaceutical development and manufacturing should be heading. It became popular after the ICH quality guide Q8 for Pharmaceutical Development was approved in its final iteration in 2009 and since that, it became a pharmaceutical “buzz term” for several years.
ObD is a Cornerstone of a New Paradigm
It is not really a pharmaceutical concept, but a broader and very useful concept related to product and process development in general. QbD is one of the cornerstones of the new paradigm of science- & risk-based regulation that is the next generation quality management paradigm in the US, EU and Japan.
It is part of the basis of the “tripartite” ICH guidelines of Q8, Q9 and Q10, later followed by Q11 and hopefully soon Q12. But since the launch of the concept, there has been significantly less hype about it. Some may even have forgotten about the concept, but QbD is not dead as a concept — it is just living a quiet life with less attention in the public debates.
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