The impact of ICH Q8, Q9 and Q10 is changing both the regulatory expectations and the strategies of Pharmaceutical Development, and this impact will continue to grow.
ICH Q8 and Quality by Design have to be seen as an overarching paradigm and
an interdisciplinary approach across the product lifecycle. It also systematically emphasises enhanced product and process understanding throughout the product
Ideally, application of ICH Q8 elements already starts in the early design phase of a drug product where both patient needs and process design are considered. During the design phase, it is important to determine the Critical Quality Attributes (CQAs), identify Critical Process Parameters (CPPs) and Critical Material Attributes (CMAs) and to understand how the process parameters and material attributes affect the CQAs. The relationship between process inputs (material attributes and process parameters) and the CQAs is described in the Design Space and ensured during manufacturing with an enhanced control strategy, leading to greater operational flexibility with reduced regulatory filing requirements.
ICH Q8 will open the door to a powerful era of refined, modern and efficient Pharmaceutical Development for those companies who are ready to invest in this new paradigm.