As stated in a recent guidance from the FDA, "Quality by design means designing and developing manufacturing processes during the product development stage to consistently ensure a predefined quality ...

And regulators like the FDA and the European Medicines Agency encourage industry to gather manufacturing data to help ensure the quality of the medicines they produce the so-called quality-by ...

Quality by Design (QbD) is a concept first outlined in 1992 by the renowned quality management expert Dr. Joseph M. Juran in his book Juran on Quality by Design: The New Steps for Planning Quality ...

Quality by Design Approach. The QbD approach, as described in the ICH guidelines 1 ICH Q8, Q9, and Q10, ensures that the developed product will consistently meet the intended performance criteria ...

With a quality-by-design approach, robust processes consistently deliver quality product. Small drug manufacturers looking to adopt a quality-by-design (QbD) approach aim to scientifically determine ...

Figure 1: When is it too late to adopt a quality-by-design approach to your product at a CDMO? (Ref. 4). In a 2008 survey, 58% of the respondents said that their QbD initiatives were only in the ideas ...

The FDA’s Quality-by-Design initiative holds potential to transform the pharmaceutical industry’s approach to drug development and manufacturing. In some ways, it’s like trying to turn a battleship.

The aim of their recent work has been to apply quality-by-design principles to build in a more scientific and risk-based, multifactorial strategy in the development of a new UHPLC methods. In this ...

Indoor air quality has always been a bit of a niche subject, even in environmental circles, but over the last few years, a growing number of people have come to realise how vital it is to our ...