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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ICH Q6B Overview<br />
Specifications; Test Procedures; and Acceptance Criteria for<br />
Biotechnology / <strong>Biological</strong> <strong>Products</strong><br />
August 1999<br />
Outil<strong>in</strong>es the nature and extent <strong>of</strong> elements needed to set<br />
mean<strong>in</strong>gful specifications for:<br />
Test Methods<br />
Process<br />
Product<br />
Specifications are the sponsor’s contract with regulatory authorities<br />
Q6B def<strong>in</strong>es the key CMC <strong>in</strong>formation that is required to support the<br />
design <strong>of</strong> specifications throughout the entire product development<br />
cycle<br />
Acceptance Criteria and Specifications are based on:<br />
The capabilities <strong>of</strong> the test methods<br />
The capabilities <strong>of</strong> the process that produces the product<br />
The nature <strong>of</strong> the lots <strong>of</strong> product produced for phase I-II-III cl<strong>in</strong>ical trials<br />
The stability <strong>of</strong> the bulk substance and f<strong>in</strong>al biological product
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