Topic 1. Challenges and Considerations for Implementation of ICH ...
Topic 1. Challenges and Considerations for Implementation of ICH ...
Topic 1. Challenges and Considerations for Implementation of ICH ...
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Breakout Session Overview<br />
Example 5: Summary <strong>of</strong> Control Elements <strong>for</strong><br />
Select CQA’s<br />
� Illustrates how part <strong>of</strong> a drug substance control<br />
strategy might be summarized in tabular <strong>for</strong>m.<br />
� Illustrates examples <strong>of</strong> upstream control, CQA <strong>and</strong><br />
specifications (<strong>and</strong>/ or drug substance specification).
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