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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Where It Is Written<br />
FDA has no specific guidance<br />
ICH Web Site:<br />
http://www.ich.org/cache/compo/276-254-1.html<br />
ICH Q3 Series on <strong>Impurities</strong> <strong>in</strong> Pharmaceutical <strong>Products</strong><br />
excludes Biotechnology / <strong>Biological</strong> <strong>Products</strong> from scope<br />
ICH Q6B – Specifications; Test Procedures; and Acceptance<br />
Criteria for Biotechnology / <strong>Biological</strong> <strong>Products</strong><br />
ICH Q5C – Quality <strong>of</strong> Biotechnology <strong>Products</strong>: Stability Test<strong>in</strong>g<br />
<strong>of</strong> Biotechnology / <strong>Biological</strong> <strong>Products</strong><br />
ICH Q5D – Derivation and Characterization <strong>of</strong> Cell Substrates<br />
Used for Production <strong>of</strong> Biotechnology / <strong>Biological</strong> <strong>Products</strong><br />
ICH Q5E – Comparability <strong>of</strong> Biotechnology / <strong>Biological</strong> <strong>Products</strong><br />
Subject to Changes <strong>in</strong> Their Manufactur<strong>in</strong>g Processes
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