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Complying with Chemistry Manufacturing and Controls (CMC) Requirements
Interactive Elements
Adults and professionals learn better when the classroom is a vibrant, stimulating place. That's why we incorporate discussions, exercises and quizzes into all of our courses. These activities reinforce training and foster a practical, hands-on educational experience.
The following is one of several interactive exercises included in Complying with CMC Requirements. Refer to the course agenda on pages 4 and 5 for additional examples.
Determing the Appropriate Post-Approval Filing Category and Supporting Chemistry Documentation to Support a Post-Approval Change
Determine the chemistry information, dissolution data, in-vivo bioequivalence requirements, and submission type to support the following changes:
- Change the manufacturing site to another company
- Equipment change:
- equipment is the same design and operating principle
- no process changes
-
Batch size change from 250,000 tablets to 100,000 tablets
-
Product marketed for 4 years
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