ICH Q11 Development and Manufacture of Drug Substance

ICH Q11 Development and Manufacture of Drug Substance Outline of Q11 Step 2 document Introduction 1. 2. Scope 3. Manufacturing Process Development 4. Description of Manufacturing Process 5. Selection of Starting Material Format: General Principles What to Submit 6. Control Strategy 7. Process Validation/Evaluation 8. Submission in CTD Format 9. Lifecycle Management 10. Illustrative Examples 11. Glossary ICH March 2012 Slide 15

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