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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Decision Tree to decide CQAs<br />
Prior<br />
Knowledge<br />
<strong>Quality</strong><br />
Attribute not<br />
a CQA<br />
<strong>Quality</strong> Attribute may not<br />
be a CQA but still be<br />
critical from a business<br />
perspective e.g. tablet<br />
thickness, appearance<br />
No<br />
Start<br />
Brainstorm list <strong>of</strong><br />
<strong>Quality</strong> <strong>Attributes</strong><br />
(potential CQAs)<br />
Is this a CQA<br />
(from a<br />
patient<br />
perspective)?<br />
Yes<br />
Apply suitable<br />
QRA tool to rank<br />
CQAs<br />
List <strong>of</strong> CQAs<br />
Unsure<br />
QTPP<br />
Experimental<br />
work to<br />
increase<br />
knowledge<br />
<strong>Critical</strong> <strong>Quality</strong> Attribute (CQA):<br />
A physical, chemical, biological or microbiological property<br />
or characteristic that should be within an appropriate limit,<br />
range, or distribution to ensure the desired product quality.<br />
Pfizer • 7
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