FDA adopts Pharmaceutical Development Guidance

The Annex to ICH Q8 Pharmaceutical Development has reached Step 4 in November 2008. The recoded Guidance for Industry Q8(R1) Pharmaceutical Development has now been adopted by the U.S. Food and Drug Administration FDA.

The 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" has been 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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