Quality by Design (QbD) in Pharmaceutical Development
Explore key concepts of Quality by Design including QTPP, CQA, CMA, CPP, risk assessment, design space, and control strategy in pharmaceutical formulation development.
Learning Objectives
At theend of the lecture, students should be able to:
•Define Quality by Design (QbD)
•Explain the need and importance of QbD
•Differentiate traditional development and QbD
•Describe the major elements of QbD
•Explain:
◦QTPP
◦CQA
◦CMA
◦CPP
◦Risk Assessment
◦Design Space
◦Control Strategy
•Describe a basic QbD development workflow
•Apply QbD concepts to a simple pharmaceutical formulation
Dr.
Chinmaya
Mahapatra
I::I::I
CM
Pharma
World
B.
Pharm
7th
Semester