On 29 October 2009, the Quality Implementation Working Group on ICH Q8, Q9 and Q10 published the Q&A document with questions and answers on these guidelines with new, additional questions.

The questions added in October 2009 include:

What is an appropriate approach for process validation using ICH Q8, Q9 and Q10?

How can information from risk management and continuous process verification provide for a robust continual improvement approach under ICH Q8, Q9 and Q10?

What is the relationship between Real-Time Release (RTR) testing and Parametric Release?

Are product specifications different for minimal versus QbD approaches?

How is control strategy approved in the application and evaluated during inspection?

Together with the answers of April 2009 and of June 2009, the answers to all of the above questions can be found in this document: http://www.ich.org/LOB/media/MEDIA5783.pdf

Author:
Dr Günter Brendelberger

On behalf of the European Compliance Academy (ECA)

PS: Budapest will be the venue for the upcoming Training Course on ICH Q9 and ICH Q10