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Criticality Assessment- Identification of Critical Quality Attributes ...

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Input (Raw) Material Characterization<br />

� Understanding the impact <strong>of</strong> raw materials on product<br />

performance.<br />

� Sources <strong>of</strong> variability in excipients<br />

� Functionality or functional properties <strong>of</strong> excipients<br />

� Important excipient properties and associated physical<br />

test methods.<br />

� Potential impacts <strong>of</strong> excipient properties against tests<br />

that might be carried out<br />

Pfizer • 9

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