Quality by design: slowly, but right and together
International Conference on Harmonization Is a hugely influential organization that offers pharmaceutical industry new approaches to drug development and application process and amends old. Any action taken by ICH or any approved recommendation is readily recognized by regulators and governments worldwide and quickly becomes a set of laws and regulations. Back in 2008, Quality by Design (QbD) approach was proposed by ICH in its key guidances Q8, Q9 and Q10. QbD is an approach to development that begins with predefined objectives, product and development process should be clearly assessed on basis of modern science at the beginning of development with risk management strategies considered.
Obviously, such approach seemed logical and was readily implemented into practice by FDA and EMA. So, in 2011 joint program for the parallel assessment of applications containing Quality by Design (QbD) elements was launched. Recently EMA released a report about results of this collaboration where it comes to obvious conclusions that EMA-FDA collaboration in an assessment of QbD applications is mutually beneficial and tells that the agencies developed three sets of questions and answers that clarify some details.
From a regulatory point of view, victory over improprieties is achieved one more time, cooperation is, as always, beneficial and regulatory practices perspective is, not surprisingly, good.
But on the other hand, QbD approach brings some complications into pharma business. Every commercial organization wants to launch a manufacturing process as fast as possible. Yet, work in accordance with QbD strategy – designing and executing studies, then analyzing them to make sense of findings – can take more time before manufacturing can start. Also, QbD can be difficult to implement when operations are geographically or functionally fragmented. For some pharma companies, worldwide QbD acceptance might feel as a pressure because their operation procedures are just not evolved enough yet.
Nevertheless, all the potential issues that may arise during QbD implementation will only stimulate industry to get better. The final report on FDA and EMA cooperation concludes that cooperation will be continued, moreover, further points for joint activities are to be discovered. Also, experts from each other’s agencies will be continuously hosted.
