Biomedical Engineering Reference
In-Depth Information
Identity
Potency
QTPP
CQAs
Purity
Others
Figure 5.3 Example to illustrate the principles behind the output of a risk assessment
and its potential impact on the patient. ( See insert for color representation of the figure .)
One of the major benefits of diagrams such as Figure 5.3 is that they paint
a clear picture of where potential risks might be and are useful, particularly at
an early stage, to establish which areas should be subject to further investigation
and analysis.
A useful risk assessment approach in relation to QbD is FMEA or FMECA
and the output from one of these is illustrated in Figure 5.4.
Safety
Efficacy
Quality
Potential CQA 1
Potential CQA 2
Potential CQA 3
Potential CQA 4
Potential CQA 5
Low impact
Medium impact
High impact
Figure 5.4 To show an example of the output of an initial risk assessments, e.g. based
on prior knowledge. ( See insert for color representation of the figure .)
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