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FDA Session
What is QbD?
Systematic, holistic and proactive approach to
pharmaceutical development.
Begins with predefined objectives
Emphasizes product and process understanding and
process control
Based on sound science and quality risk management
Ref.: ICH Q8
(R2)
A QbD workflow
Required
Quality target product profile (QTPP) including critical quality attributes (CQAs) of the
drug product and including Product design and understanding
Product design and understanding
Critical material attributes (CMAs) of the drug substance and excipients
Process design and understanding
Critical process parameters (CPPs)
Control strategy, including justification
Optional
Design Space
Process Analytical Technology
QbD example
A:Elution pH B:Conductivity C:Cleavage D:Load Mass E:Wash pH Recovery % Purity %
-1
-1
-1
-1
1
112.6
96.3
1
-1
-1
-1
-1
90.7
96.9
-1
1
-1
-1
-1
104.9
97.1
1
1
-1
-1
1
72.8
97.3
-1
-1
1
-1
-1
99.6
96.1
1
-1
1
-1
1
84.2
97.1
-1
1
1
-1
1
98.4
97.3
1
1
1
-1
-1
104.2
97.8
-1
-1
-1
1
-1
104.3
91.8
1
-1
-1
1
1
79.0
94.9
-1
1
-1
1
1
94.8
96.6
1
1
-1
1
-1
93.7
96.0
-1
-1
1
1
1
95.5
94.4
1
-1
1
1
-1
88.5
93.9
-1
1
1
1
-1
78.7
96.5
1
1
1
1
1
58.7
98.4
QbD example
Purity
1.00
96.6333
0.50
B: Conductivity
96.1792
D es ign-E xpert Sof tw are
Ov erlay P lot
R ec ov ery
P uri ty
X 1 = A : E lut ion pH
X 2 = B : C onduct ivi ty
A c tual F actors
C : C leav age = -1. 00
D : Load Mas s = 0.0 0
E : Was h pH = 0. 00
Overlay Plot
0.00
1.00
95.725
-0.50
95.2708
0.50
-1.00
-1.00
-0.50
0.00
0.50
1.00
A: Elution pH
Des ign-E xpert So ftware
Rec over y
112 .6
58. 7
X1 = A: Elution p H
X2 = B: Conduc t ivit y
Ac t ual F ac tors
C: Cle avage = -1 .0 0
D: Lo ad Mas s = 0.0 0
E: W ash pH = 0. 00
Recovery
1.00
B: Conductivity
94.8167
Recovery: 100
0.00
Recovery: 90
-0.50
B: Conductivity
0.50
-1.00
-1.00
99.8417
95.4875
91.1333
-0.50
0.00
86.7792
0.00
A: Elution pH
104.196
-0.50
-1.00
-1.00
-0.50
0.00
A: Elution pH
0.50
1.00
0.50
1.00
plant
sample
or
characterize
each
dietary