The Institute of Validation Technology (IVT) has released an article that discusses quality-by-design (QbD) as an approach which can be applied to analytical procedures, as well as for production processes.
QbD is: “A systematic approach to development that begins with predefined objectives and emphasises product and process understanding and process control, based on sound science and quality risk management.”
The analytical procedure can be viewed as a process with a reportable result as its output. To better apply QbD to analytical procedures; it is useful to compare the application of QbD in the two areas. (See image).
To read the full article “Quality-by-design for analytical procedures” please click here.
