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

Recommendation

15/16 September 2020
Berlin, Germany

ICH Q12 - Product Life Cycle Management

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.