The importance of pulling the generics industry more directly into the QbD/ICH Q8-10 implementation process was stressed by key regulatory and industry officials during the concluding session at the ICH Quality Implementation Working Group (IWG) workshop in Tallinn, Estonia in early June.
The workshop was sponsored by the associations PDA and ISPE, with PDA’s European office, headed by Georg Roessling having primary responsibility for Tallinn.
Among the prominent voices speaking up for the importance of generics industry inclusion in QbD implementation was MHRA Expert Inspector Ian Thrussel. Innovator firms may now be on the QbD bandwagon, but generics are the medicines most people take and a way needs to be found to drive the new manufacturing paradigm forward in this industry group, he asserted.
Thrussel pointed out that “it will be many years before the people in this room and their families take quality-by-design medicines…. Big pharma may well have been the innovators, but they are not the major providers of the medicines” taken by patients today.
[More on the discussion in Estonia regarding the importance of QbD application by the generics industry is available to subscribers here.]
