Regulatory Aspects of Impurities in Biological Products - IIR
Regulatory Aspects of Impurities in Biological Products - IIR
Regulatory Aspects of Impurities in Biological Products - IIR
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Process-Related Impurity Decision Tree and<br />
Specifications Inspired by Q6B<br />
Heather Simmerman <strong>of</strong> Amgen first suggested a<br />
decision tree format at the CMC Strategy Forum,<br />
July 2004<br />
Basis <strong>in</strong> Q6B<br />
Identify Impurity<br />
Develop a suitable assay to measure the impurity<br />
Assess the safety risk <strong>of</strong> the impurity<br />
Understand the capability <strong>of</strong> the process to control the<br />
impurity<br />
Set mean<strong>in</strong>gful specifications from the understand<strong>in</strong>g<br />
<strong>of</strong> critical process parameters that produce a product<br />
with appropriate impurity characteristics
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