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>: Conclusions<br />
<strong>Identification</strong> <strong>of</strong> CPP & CQA<br />
Process Parameter <strong>Quality</strong> <strong>Attributes</strong><br />
Raw Material<br />
<strong>Attributes</strong><br />
Bin Blend<br />
Roller Compaction<br />
Bin Blend<br />
Compression<br />
Film Coating<br />
Polymer Viscosity,<br />
Polymer Functionality<br />
Blending time / end point<br />
Roll force<br />
Roll gap<br />
Roll speed<br />
Feed screw rate<br />
Milling conditions<br />
Blend time/end point<br />
Compression force<br />
Press speed<br />
Feeder speed<br />
Pan Speed<br />
Environmental<br />
Efficiency Factor (EEF)<br />
Blend Uniformity<br />
Ribbon <strong>Attributes</strong><br />
• Porosity<br />
Granule <strong>Attributes</strong><br />
• psd<br />
Tablet Hardness<br />
Blend Uniformity<br />
Tablet <strong>Attributes</strong><br />
• Hardness<br />
• Dissolution<br />
Appearance,<br />
Tablet weight gain<br />
Clinical relevance<br />
Pfizer • 33
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