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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Outline<br />
� Define product goal via establishment <strong>of</strong> <strong>Quality</strong> target product<br />
Pr<strong>of</strong>ile (QTPP)<br />
� Determination <strong>of</strong> <strong>Critical</strong> <strong>Quality</strong> <strong>Attributes</strong> (CQAs)-Identify the<br />
CQAs based on prior knowledge and QTPP<br />
� Use prior knowledge and risk assessment to identify the critical<br />
parameters or attributes. Establish link between CPP & CQAs. Use<br />
risk management techniques to prioritize the parameters to study.<br />
� Establishment <strong>of</strong> <strong><strong>Critical</strong>ity</strong>- CPP & CQA<br />
� Provide key learning from company experience and future<br />
directions<br />
1<br />
Pfizer • 1
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