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QUALITY BY DESIGN (QbD)
Dr. Chinmaya Mahapatra
Learning Objectives
At the end 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
Dr.
Chinmaya
Mahapatra
I::I::I
CM
Pharma
World
B.
Pharm
7th
Semester
Dr.
Chinmaya
Mahapatra
I::I::I
CM
Pharma
World
B.
Pharm
7th
Semester
Dr.
Chinmaya
Mahapatra
I::I::I
CM
Pharma
World
B.
Pharm
7th
Semester
Dr.
Chinmaya
Mahapatra
I::I::I
CM
Pharma
World
B.
Pharm
7th
Semester
Dr.
Chinmaya
Mahapatra
I::I::I
CM
Pharma
World
B.
Pharm
7th
Semester
Dr.
Chinmaya
Mahapatra
I::I::I
CM
Pharma
World
B.
Pharm
7th
Semester
Dr.
Chinmaya
Mahapatra
I::I::I
CM
Pharma
World
B.
Pharm
7th
Semester
Dr.
Chinmaya
Mahapatra
I::I::I
CM
Pharma
World
B.
Pharm
7th
Semester
Dr.
Chinmaya
Mahapatra
I::I::I
CM
Pharma
World
B.
Pharm
7th
Semester
Dr.
Chinmaya
Mahapatra
I::I::I
CM
Pharma
World
B.
Pharm
7th
Semester
Dr.
Chinmaya
Mahapatra
I::I::I
CM
Pharma
World
B.
Pharm
7th
Semester
Dr.
Chinmaya
Mahapatra
I::I::I
CM
Pharma
World
B.
Pharm
7th
Semester
Dr.
Chinmaya
Mahapatra
I::I::I
CM
Pharma
World
B.
Pharm
7th
Semester
Dr.
Chinmaya
Mahapatra
I::I::I
CM
Pharma
World
B.
Pharm
7th
Semester
Dr.
Chinmaya
Mahapatra
I::I::I
CM
Pharma
World
B.
Pharm
7th
Semester
Dr.
Chinmaya
Mahapatra
I::I::I
CM
Pharma
World
B.
Pharm
7th
Semester
Dr.
Chinmaya
Mahapatra
I::I::I
CM
Pharma
World
B.
Pharm
7th
Semester
Dr.
Chinmaya
Mahapatra
I::I::I
CM
Pharma
World
B.
Pharm
7th
Semester
Dr.
Chinmaya
Mahapatra
I::I::I
CM
Pharma
World
B.
Pharm
7th
Semester
Dr.
Chinmaya
Mahapatra
I::I::I
CM
Pharma
World
B.
Pharm
7th
Semester
Dr.
Chinmaya
Mahapatra
I::I::I
CM
Pharma
World
B.
Pharm
7th
Semester
Dr.
Chinmaya
Mahapatra
I::I::I
CM
Pharma
World
B.
Pharm
7th
Semester
Dr.
Chinmaya
Mahapatra
I::I::I
CM
Pharma
World
B.
Pharm
7th
Semester
Dr.
Chinmaya
Mahapatra
I::I::I
CM
Pharma
World
B.
Pharm
7th
Semester
Dr.
Chinmaya
Mahapatra
I::I::I
CM
Pharma
World
B.
Pharm
7th
Semester
Dr.
Chinmaya
Mahapatra
I::I::I
CM
Pharma
World
B.
Pharm
7th
Semester
Dr.
Chinmaya
Mahapatra
I::I::I
CM
Pharma
World
B.
Pharm
7th
Semester
Dr.
Chinmaya
Mahapatra
I::I::I
CM
Pharma
World
B.
Pharm
7th
Semester
Dr.
Chinmaya
Mahapatra
I::I::I
CM
Pharma
World
B.
Pharm
7th
Semester
Dr.
Chinmaya
Mahapatra
I::I::I
CM
Pharma
World
B.
Pharm
7th
Semester
Dr.
Chinmaya
Mahapatra
I::I::I
CM
Pharma
World
B.
Pharm
7th
Semester
Dr.
Chinmaya
Mahapatra
I::I::I
CM
Pharma
World
B.
Pharm
7th
Semester
Dr.
Chinmaya
Mahapatra
I::I::I
CM
Pharma
World
B.
Pharm
7th
Semester
Dr.
Chinmaya
Mahapatra
I::I::I
CM
Pharma
World
B.
Pharm
7th
Semester