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 www.pat-conference.org. 

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