Annex to ICH Q8 Pharmaceutical Development reached Step 5

The Annex to ICH Q8 Pharmaceutical Development reached Step 5. Its implementation date is June 2009.

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 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.

Source: EMEA

Hear about best practices from early development up to efficient IMP-supplies and learn how Quality by Design and faster time to market could be realised at Part 1 of the ECA 3rd Good Development Practice Conference: Pharmaceutical Development and Quality by Design - Important Aspects of efficient Pharmaceutical Development , 26 – 27 May 2009, Copenhagen, Denmark

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

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