6 December 2011

At its meeting in Seville in November 2011, the ICH Quality Implementation Working Group finalised three Points to Consider topics covering: Role of Models in Quality by Design (QbD); Design Space; and Process Validation/Continuous Process Verification. The three topics were added to the three existing Points to Consider topics which were released in June 2011. This additional material, relevant to the implementation of ICH Q8(R2), Q9 and Q10, further complements the existing Questions & Answers and workshop training materials already produced by this group.

The updated Points to Consider document is available from the Q8/Q9/Q10 Implementation Section under Q8, Q9 and Q10 on the Quality Guideline page.