Criticality Assessment- Identification of Critical Quality Attributes ...
Criticality Assessment- Identification of Critical Quality Attributes ...
Criticality Assessment- Identification of Critical Quality Attributes ...
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Risk <strong>Assessment</strong>: Pareto Chart-Relative Importance<br />
<strong>of</strong> Inputs<br />
Percent Importance<br />
16.00%<br />
14.00%<br />
12.00%<br />
10.00%<br />
8.00%<br />
6.00%<br />
4.00%<br />
2.00%<br />
0.00%<br />
POLYMER<br />
CONCENTRATION<br />
POROSITY/ ROLL<br />
FORCE/ ROLL GAP<br />
COMPRESSION<br />
MACHINE SPEED<br />
ROLLER<br />
COMPACTOR<br />
FEEDER SPEED<br />
COMPRESSING<br />
FORCE<br />
<strong>Quality</strong> Compliance Priority<br />
Manufacturing Priority<br />
FINAL BLEND<br />
LUBRICATION TIME<br />
API PARTICLE SIZE<br />
PSD OF INTRA-<br />
GRANULAR BLEND<br />
PRIMARY BLEND<br />
TIME<br />
EXCIPIENT PARTICLE<br />
SIZE<br />
PRE-COMPRESSION<br />
FORCE<br />
Pfizer • 31
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