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ICH Q11 Development and Manufacture of Drug Substance slide image

ICH Q11 Development and Manufacture of Drug Substance

ICH Q11 Development and Manufacture of Drug Substance Outline of Q11 1. Introduction 2. Scope 3. Manufacturing Process Development Important to read Q11 as a "whole" NOT individual sections out of context Process Validation/Evaluation Submission in CTD Format 7. 8. 9. Lifecycle Management 10. Illustrative Examples 11. Glossary March 2012 ICH Slide 16
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