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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Q6B Suggests a Specifications Design Record<br />
for <strong>Impurities</strong><br />
Identify the impurity<br />
Measure the impurity with suitable test methods<br />
Assess safety risks <strong>of</strong> the impurity<br />
Design the process to be capable <strong>of</strong> clear<strong>in</strong>g or at least<br />
reduc<strong>in</strong>g impurities <strong>of</strong> concern<br />
Characterize / validate the process to understand and<br />
demonstrate critical process parameters that yield<br />
impurity control for the product<br />
Submit impurity specifications that reflect an<br />
understand<strong>in</strong>g <strong>of</strong> impurity risk and process capability to<br />
produce a product with safe impurity levels
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