Common CMC (Quality) Issues and How to Avoid Them Part I (12of16) Generic Drugs Forum скачать в хорошем качестве

Common CMC (Quality) Issues and How to Avoid Them Part I (12of16) Generic Drugs Forum

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. Learn more at https://www.fda.gov/drugs/news-events... _______________________________ FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research. Upcoming training and free continuing education credits: https://www.fda.gov/cdersbia CDER SBIA 2020 Playlist:    • 2020 CDER Small Business and Industry Assi...   LinkedIn:   / cder-small-business-and-industry-assistance   Training resources: https://www.fda.gov/cderbsbialearn Twitter:   / fda_drug_info   CDER small business e-mail update subscription: https://updates.fda.gov/subscriptionm... Email: CDERSBIA@fda.hhs.gov Phone: (301) 796-6707 I (866) 405-5367