New EMEA Q&As on ICH Q8, Q9 and Q10

In June 2009, the EMEA published a questions-and-answers document on the ICH topics Q8, Q9 and Q10. This document is meant to help in implementing and interpreting the requirements laid down in the three guidelines in a harmonised way in all three ICH regions.

The document begins with the question if the so-called "minimal approach" is still accepted by regulators. The ICH Q8(R1) Guideline does distinguish between a minimal approach and an enhanced QbD approach, a systematic approach including the use of PAT tools. The answer is that, still today, the minimal approach is perfectly acceptable for a submission. However, the pharmaceutical enterprises are encouraged to choose the new enhanced approach as described in the appendix to ICH Q8(R1).

The questions added in June 2009 include among others:

  • Does a set of proven acceptable ranges alone constitute a design space?
  • What is the relationship between in-process testing and RTR (real-time release) testing?
  • Can surrogate measurement be used for RTR testing?
  • What approaches can be taken in the event of on-line / in-line / at-line testing or monitoring equipment breakdown?
  • What information and documentation of the development studies should be available at a manufacturing site?
  • Can process parameters be adjusted throughout the product lifecycle?
  • Will regulatory agencies expect to see a formal knowledge management approach during inspections?

The complete document can be found here.

ICH Q8, Q9 and Q10 are among the important issues at the University of Heidelberg QbD/PAT Conference 2009 to be held at the Marriott Hotel in Heidelberg from 29 September to 1 October 2009. EMEA's David Cockburn presents and interprets this ICH guideline from a European viewpoint at this conference. You can find the detailed programme at

Dr Günter Brendelberger
On behalf of the European Compliance Academy (ECA)

Conference Recommendations

Go back

GMP Conferences by Topics