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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Output Example 5- Summary <strong>of</strong> Control Elements-<br />
Control Strategy<br />
� Specification <strong>of</strong> API is just a part <strong>of</strong> control strategy.<br />
� Not all CQA’s need to be included in spec or tested in API<br />
� Upstream control along with purging allows <strong>for</strong> higher levels <strong>of</strong> impurities than those defined<br />
in spec.<br />
� Certificate <strong>of</strong> Analysis vs specification- does this cause confusion?<br />
� CS table is presented in S4.5 (Justification <strong>of</strong> Spec)
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