GDF2025 – D2S13 - Navigating Challenges in Drug Manufacturing скачать в хорошем качестве

GDF2025 – D2S13 - Navigating Challenges in Drug Manufacturing

The presentation provided an overview of common deficiencies observed in drug manufacturing process and the critical observations form pre-approval inspections that significantly impact generic drug applications. By examining the broad trends, the attendees will gain a dapper understanding of the key areas that require attention to ensure compliance and quality in drug manufacturing. Timestamps 01:05 – USA Marketed Generic Drugs 02:41 – CRL Deficiencies 03:56 – Major CRL Deficiencies 05:00 – Collection and Analysis of Data 06:11 – Major CRL Manufacturing Process Deficiencies for FY23 by Dosage Form 08:09 – Resources for Major Manufacturing Process Deficiencies for FY23 09:27 – Facility Deficiencies 18:28 – Summary Speaker: Andrew Idzior Chemist Office of Pharmaceutical Manufacturing Assessment (OPMA) Office of Pharmaceutical Quality (OPQ) | CDER 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 - https://www.fda.gov/cdersbia SBIA Listserv - https://public.govdelivery.com/accoun... SBIA 2024 Playlist -    • 2024 CDER Small Business and Industry Assi...   SBIA 2025 Playlist -    • 2025 CDER Small Business and Industry Assi...   SBIA LinkedIn -   / cder-small-business-and-industry-assistance   SBIA Training Resources - https://www.fda.gov/cdersbialearn Twitter -   / fda_drug_info   Email - CDERSBIA@fda.hhs.gov Phone - (301) 796-6707 I (866) 405-5367