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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<strong>1.</strong> Introduction<br />
2. Scope<br />
Outline <strong>of</strong> Q11<br />
3. Manufacturing Process Development<br />
4. Description <strong>of</strong> Manufacturing Process<br />
5. Selection <strong>of</strong> Starting Materials & Source Materials<br />
6. Control Strategy<br />
7. Process Validation/Evaluation<br />
8. Submission in CTD Format<br />
9. Lifecycle Management<br />
10. Illustrative Examples<br />
1<strong>1.</strong> Glossary
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