Quality by Design: Lessons learnt from EMA/FDA Pilot Program

Recommendation
18-20 November 2025
Heidelberg, Germany
GMP and FDA Compliance in Pharmaceutical Development and IMP Manufacturing
In March 2011, the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) launched a joined pilot program on Quality by Design (QbD) applications. The aim was to evaluate a possible parallel assessment by both agencies of certain quality/CMC sections which are relevant to Quality by Design (QbD), such as development, design space and real time release testing.
In the meantime, the first EMA-FDA parallel assessment of an initial marketing authorisation application has been finalised. Both agencies experienced the pilot program as "extremely useful to share knowledge, facilitate a consistent implementation of the ICH guidelines and to harmonise regulatory decisions to the greatest extent possible", as stated in a report published on 20 August 2013 (EMA/430501/2013).
As a result of this pilot program, the EMA and FDA reached agreements on a wide range of QbD aspects, which are summarised in a Q&A section in the report. Questions discussed here are about
- Quality Target Product Profile (QTPP)
- Critical Quality Attributes (CQAs)?
- Classification of criticality for process parameters
- Description of the manufacturing process
- Analytical target profile (ATP)
- Method Operational Design Ranges (MODR)
To get more information please see the "EMA-FDA pilot program for parallel assessment of QbD applications" paper.
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