Quality by Design ppt

1. A Seminar on...
Quality-by-Design in Pharmaceutical Development
1
Presented by-
Vijay verma
M.Pharm 2nd Semester
Roll No. 8561013
University Institute Of Pharmacy

2. • Introduction to Quality
• Quality by Design (QbD)
• Significance of Quality by Design
• QbD frame (in ICH docs)
• Use of QbD approach
• Target product quality profile
• Critical quality attributes
• Material attributes
• Process parameter
• Design space & determination
• Control strategy
• Risk assessment
• Importance of QbD for Formulation and Development
• Conclusion
• References
Content
2

3. The suitability of either a drug substance or a
drug product for its intended use.
The term include such attributes as the
identity, strength & purity
It also refer to product free of contamination
and reproducibly delivers the therapeutic
benefit promised in the label to consumer
Quality
3

4. A systematic approach to development that begins
with predefined objectives and emphasizes
product and process understanding and process
control, based on science and quality risk
management
Quality by Design is emerging to enhance the
assurance of safe, effective drug supply to
consumer and also offer promise to significantly
improve manufacturing quality performance.
Quality by Design
4

5. 5

6. 6

7. 7

8. 8

9. 9

10. 10

11. 11

12. 12

13. 13

14. 14

15. 15

16. 16

17. • Quality target product profile
• Critical quality attributes
• Initial risk assessment for drug formulation
1. Selection of Excipients
2. Excipients compatibility studies
3. Development of formula for initial formulation development
• Design development strategies
• Scale up from lab to pilot scale and then
commercial scale
Importance of QbD for Formulation and
Development
17

18. 18

19. 19