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 1<br />
Is the nature and source <strong>of</strong> the impurity known?<br />
Have sensitive and broad detection methods been<br />
used to discover impurities?<br />
Yes- go to question 2<br />
No<br />
Demonstrate your impurity screen<strong>in</strong>g methods are not<br />
<strong>in</strong>sensitive and/or have narrow vision<br />
Categorize the nature and source <strong>of</strong> the impurity<br />
Process-Related, Product-Related, Contam<strong>in</strong>ant<br />
Inorganic, organic, biochemical, microbiological, physical<br />
Cell substrate, cell culture, down-stream, adventitious
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