Quality: Quality by Design (QbD)

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

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

Guidelines

• ICH Q8 (R2) Pharmaceutical development
• ICH Q9 Quality risk management
• ICH Q10 Pharmaceutical quality system
• ICH guideline Q13 on continuous manufacturing of drug substances and drug products
• ICH Q8, Q9 and Q10 - questions and answers
• ICH guideline Q13 on continuous manufacturing of drug substances and drug products
• Real time release testing
• Use of near infrared spectroscopy (NIRS) by the pharmaceutical industry and the data requirements for new submissions and variations - Scientific guideline

Questions and answers

European Medicines Agency-Food and Drug Administration pilot programme for parallel assessment of quality-by-design applications: lessons learnt and questions and answers resulting from the first parallel assessment

Reference Number: EMA/430501/2013

Questions and answers on design-space verification

Reference Number: EMA/603905/2013

Questions and answers on level of detail in the regulatory submissions

Reference Number: EMA/59240/2014

Questions and answers: improving the understanding of normal operating range (NOR), proven acceptable range (PAR), design space (DSp) and normal variability of process parameters

Reference Number: EMA/CHMP/CVMP/QWP/354895/2017 Summary:

Questions and answers: improving the understanding of NORs, PARs, DSp and normal variability of process parameters