Biomedical Engineering Reference
In-Depth Information
TABL E 10.1. QbD Risk Assessment Scorecard Example for Focus Area 3
Quality Attribute/Rank
10
7
7
10
10
7
7
7
10
10
5
Process
Parameter
Concentration
of Active
Content
Uniformity
Process
Time
Experimental
Strategy
Deamidation Oxidation Aggregation
pH Color
Clarity
Fragmentation
Bioactivity
SCORE
Temperature
1
10
10
10
1
7
7
10
1
10
1
543
DOE1
Excipient
weight accuracy
1
7
7
10
10
1
7
5
1
7
7
514
DOE1
Drug substance
solution pH
1
10
1
7
10
5
1
10
1
5
7
464
DOE1
Hold time of bulk
drug substance
1
7
7
7
1
5
5
10
1
7
10
458
DS stability
Drug substance
weight accuracy
10
1
1
1
7
5
1
5
1
10
10
431
FMEA1
Mixing Time
1
5
5
5
1
1
5
1
10
5
10
389
OFAT1
Mixing Speed
1
1
5
5
1
1
5
1
10
5
7
346
OFAT1
Excipient handling
1
1
10
5
1
1
1
5
1
5
1
261
FMEA2
pH meter accuracy
1
1
1
1
10
1
1
1
1
1
10
225
FMEA3
Operator/analyst
training
1
1
1
5
1
1
1
1
7
1
5
210
on-the-
job-training
Excipient quality
1
1
5
1
5
5
1
1
1
1
1
186
FMEA4
Order of excipient
addition
1
1
1
1
1
1
1
1
5
1
1
130
FMEA5
