1. Quality by design (Qbd)
November 14 –15, 2016
Youness AMEUR

2. Summary
I- Definition of Qbd II- Different steps of Qbd III- Traditional approach vs Qbd IV- Qbd’s Impact on the cost V- Conclusion

3. I- Definition
Describe in ICH Q8 (R2) pharmaceutical development (dated August 2009)
Guide the development towards an increased knowledge from the beginning of the product design
Organize this knowledge to monitor later the product and the manufacturing process optimally.

4. II- Different steps of Qbd
1) Quality Target Product Profile (QTPP)
2) Critical Quality Attributes (CQA)
3) Risk Assessment
4) Design Space
5) Control Strategy
6) Product Lifecycle Management and Continual Improvement

5. III- Traditional approach vs. Qbd

6. Fixed Manufacturing Process with fixed parameters
Traditional approach
Fixed Manufacturing Process with fixed parameters
Final Product with the targeted quality
Raw materials

7. Variable Raw materials Adjustable Manufacturing Process
Qbd approach
Variable Raw materials
Adjustable Manufacturing Process
Final Product with the required quality

8. IV- Qbd’s Impact on the cost

9. Cours du Professeur Véronique ANDRIEU - 2015

10. http://www. allfordrugs
(consulted 10/11/2016)

11. V- Conclusion
Qbd is an improved and modern approach to pharmaceutical quality
A better knowledge of the manufacturing process and the product
Flexible process within design space, allowing continuous improvement
Decrease costs and ensure quality of products

12. Thank you for your attention