In chemical manufacturing, the process involved in creating a breakthrough new solvent or substance often takes years, or even decades, with ongoing tests that may be based on trial and error as much as specifically applied knowledge. One area of development that is particularly important in the chemical industry is creating new substances called plasticizers that can help resins or polymers retain a more supple or flexible nature.
Using a Quality by Design (QbD) approach for DOE supports ICH Q8 compliance
In pharmaceutical development, manufacturers must be able to demonstrate product robustness and deliver the intended quality of the product within allowable ranges for the claimed shelf-life period. Both international and country specific regulatory agencies, such as the FDA, pay close attention to these claims.