Quality: Quality by Design (QbD)

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The European Medicines Agency’s scientific guidelines on Quality by Design help medicine developers prepare marketing authorisation applications for human medicines.

If you have comments on a document which is open for consultation, use the form for submission of comments on scientific guidelines.

For a complete list of scientific guidelines currently open for consultation, see Public consultations.

Guidelines


Questions and answers

EMA-FDA pilot program for parallel assessment of Quality-by-Design applications: lessons learnt and Q&A resulting from the first parallel assessment

Questions and answers on Design Space Verification

Questions and answers on level of detail in the regulatory submissions

Questions and answers on improving the understanding of Normal Operating Range (NOR), Proven Acceptable Range (PAR), Design Space (DSp) and normal variability of process parameters

    

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