GDF2026 - Manufacturing Deficiencies in Liquid Drug Products: The Top Ten Issues
Office of Pharmaceutical Manufacturing Assessment (OPMA), FDA · July 30, 2026
A presenter from the FDAs Office of Pharmaceutical Manufacturing Assessment summarized findings from a review of IQAs and identified filling-and-sealing batch records as the most common manufacturing deficiency, urged applicants to use FDA guidances, and reviewed data and regulatory references.
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