| Summary: | The misapplication of QbD for purposes for which it was not intended for is unwise andlikely to be counterproductive. It would be a shame if, by virtue of such misapplication, the QbD paradigm were to be maligned or abandoned,
because there is no denying that it does bring added value to pharmaceutical manufacturing processes. Ill-conceived and/or improper application of QbD, including any that treat pharmaceutical processes as “modular” and being totally mathematically patterned, must be curbed. The proper application of QbD to establish and optimize the ‘design space’ of thoughtfully developed (i.e. grounded in a sufficient knowledge and understanding of physical and organic chemistry, materials science, process engineering together with experience and judgement) formulations and processes should be increased, so that its full potential may then be realized.
|
|---|