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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Question 5<br />
Is the level <strong>of</strong> the impurity throughout the<br />
process known?<br />
Yes – Question 6<br />
No<br />
Measure the impurity at appropriate process po<strong>in</strong>ts<br />
Determ<strong>in</strong>e the reproducibility at the appropriate<br />
process po<strong>in</strong>ts<br />
Is the stability <strong>of</strong> the impurity impacted by different<br />
process variables? Adjust approach based on data.
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