In 2004 US Food and Drug Administration (FDA), as part of the Process Analytical Technology Guidance,introduced the idea of Quality by Design (QbD). The core objective was to design quality into the process andproduct rather than try to check quality of the product at the end of production. It has been known since long timethat “quality by testing” is a low-yield and costly strategy. ICH, in 2005, outlined the concept of design space in itsQ8 guideline related to development of pharmaceuticals. Since that time, pharmaceutical companies, despitedepending on innovation for their livelihood, have been adopting QbD for new drug applications (NDA) and aswell as for Abbreviated New Drug applications (ANDA). In nutshell it has been observed that, now QbD isbecoming mainstay of development of pharmaceutical products.

In 2004 US Food and Drug Administration (FDA), as part of the Process Analytical Technology Guidance,introduced the idea of Quality by Design (QbD). The core objective was to design quality into the process andproduct rather than try to check quality of the product at the end of production. It has been known since long timethat “quality by testing” is a low-yield and costly strategy. ICH, in 2005, outlined the concept of design space in itsQ8 guideline related to development of pharmaceuticals. Since that time, pharmaceutical companies, despitedepending on innovation for their livelihood, have been adopting QbD for new drug applications (NDA) and aswell as for Abbreviated New Drug applications (ANDA). In nutshell it has been observed that, now QbD isbecoming mainstay of development of pharmaceutical products.