Common CMC (Quality) Issues and How to Avoid Them Part I (12of16) Generic Drugs Forum
Автор: U.S. Food and Drug Administration
Загружено: 2020-05-01
Просмотров: 7145
Simin Hassannejad Tabasi and Pei-I Chu from the CDER Office of Pharmaceutical Quality discuss common drug product quality issues and CMC issues for manufacturing process and facility reviews.
Hassannejad Tabasi discusses ANDA applications related to Solid Oral Drug Products (SODP), identifies the most common areas of quality gaps in the ANDA submission, and possible resolutions.
Chu shares the key elements of process and facility review, commonly seen deficiencies for various dosage forms, and considerations for information to be included in the submission.
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