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FDA presenter summarizes OPMA review, says filling-and-sealing defects top concern
Summary
A presenter from the FDA—s Office of Pharmaceutical Manufacturing Assessment summarized analysis of 1,850 IQAs and more than 6,500 information requests, urging applicants to prioritize filling-and-sealing issues and to use FDA guidances to speed approvals.
A presenter from the Food and Drug Administration—s Office of Pharmaceutical Manufacturing Assessment (OPMA) told attendees the office—s review of internal assessment documents shows filling-and-sealing problems are the most frequent manufacturing deficiency.
"Everyone deserves confidence in their next dose of medication," the Presenter said, framing the analysis as a patient-safety and availability issue. OPMA reviewed more than 2,000 integrated quality assessments and used 1,850 from January 2019 to June 2023, which the Presenter said produced more than 6,500 information requests or deficiencies.
The Presenter gave a ranked list of the top 10 deficiencies observed across liquid drug products (injectables, oral dosage forms, topicals and insufflates), saying applicants should prioritize filling-and-sealing batch records and in-process controls but also address mixing, filtration, and drug-substance attributes. The Presenter read the top-10 list out loud and said the data-driven review was intended to help manufacturers focus remediation where it will most affect approval timelines.
OPMA recommended applicants consult FDA guidances and standards (including ICH Q8—Q10 and relevant USP standards) and to include data such as lyo cycle graphs, equipment loads and IPCs in submissions where applicable. The office also described recent procedural changes intended to speed reviews, such as sending discipline letters and additional information requests later in the assessment cycle under GDUFA 3 and PDUFA 7—era processes.
The Presenter closed by encouraging applicants to address filling-and-sealing issues first and to use the referenced guidances to reduce review cycles.
