The ICH Quality Implementation Working Group (Q-IWG) has issued volume 4 of the ICH guideline Q8, Q9 and Q10 - Questions and Answers Document. This document has now been published on the EMA website (EMA/CHMP/ICH/265145/2009).
The first volume was issued late 2008 with the aim to further describe and interpret details of the three existing guidelines and to facilitate the implementation of for example Design Space, Real Time Release Testing or Knowledge Management
In the latest update, the question is discussed if the outer limits of the Design Space should be evaluated during process validation studies at the commercial scale?
The answer is no. "There is no need to run the qualification batches at the outer limits of the design space during process validation studies at commercial scale. The design space must be sufficiently explored earlier during development studies."
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)
P.S. You will be updated on the latest regulatory developments and learn how to apply the respective paradigms to be better able to design strategies for the implementation of ICH Q8 and Quality by Design in the ECA ICH Q8 Master Class in Berlin, Germany, from 5-6 May 2011.