Spring Intro 2023

03/03/2023

Quality by Design (QbD)

• Is a Design Space being proposed? • ICH Q8, ICH Q9 and Q11 Guidelines • Has the relationship between the process inputs (material attributes and process parameters) and the critical quality attributes of the active substance and/or drug product been established in a multivariate manner? • Validation and manufacturing process development included

03/03/2023

47

47

Quality by Design (QbD) - continued

• Is a Design Space being proposed or not? • Principles of ICH Q8, ICH Q9 and Q11 Guidelines followed and presented in Pharmaceutical Development – large amount of data submitted in order to present scientific knowledge • However DS not proposed for commercial manufacturing

03/03/2023

48

48

24