Annex to ICH Q8 Pharmaceutical Development reached Step 4

"The International Conference on Harmonisation (ICH) Steering Committee and its expert working groups met in Brussels from November 8 - 13, 2008. Highlights of the meeting achievements are outlined below.

The Annex to ICH Q8 Pharmaceutical Development reached Step 4 in Brussels. This document builds on key concepts outlined in the core guideline, and shows how tools such as Quality by Design could be put into practice. It is envisaged that greater understanding of pharmaceutical and manufacturing sciences will create a basis for more flexible regulatory approaches. The Quality Implementation Working Group that was established at the Portland meeting, will be developing a Q&A document to answer questions arising from the new Q8, Q9, and Q10 guidelines. These quality guidelines promote a more conceptual and flexible approach to pharmaceutical quality."

The parent guideline “Pharmaceutical Development” is now recoded Q8(R1) following the addition of the Annex to the parent guideline and giving more details on elements like:

  • Quality Target Product Profile
  • Critical Quality Attributes
  • Defining a Control Strategy
  • Risk Assessment
  • Design Space

and how the related information should be submitted in the CTD format.

Compiled by:
Wolfgang Schmitt
On behalf of the European Compliance Academy (ECA)

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