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 7<br />
Would the impurity pose a significant safety risk if<br />
present or does it affect the stability <strong>of</strong> the drug<br />
substance?<br />
Yes<br />
Set acceptance criteria for impurity <strong>in</strong> drug substance<br />
Base on pre-cl<strong>in</strong>ical and cl<strong>in</strong>ical safety studies and the process<br />
capability to remove<br />
Consider regulatory compendial requirements and guidance<br />
documents<br />
Establish mass balance for toxic additives<br />
No<br />
Consider sett<strong>in</strong>g <strong>in</strong>-process acceptance criteria or limits to<br />
ensure control <strong>of</strong> process removal<br />
If the impurity co-purifies, b<strong>in</strong>ds-to, or modifies the drug<br />
substance, these controls are more important
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