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FDA analysis: filling-and-sealing batch records top deficiency, agency says applicants should start there
Summary
OPMA—s presenter said filling-and-sealing issues accounted for the largest share of deficiencies in a review of 1,850 IQAs, with batch records and IPCs repeatedly cited; applicants were urged to include supporting batch-level data to avoid delays.
A presenter for the FDA—s Office of Pharmaceutical Manufacturing Assessment said the filling-and-sealing unit operation emerged as the single largest source of deficiencies in OPMA—reviews.
"The filling and sealing unit is the unit operation with the most deficiencies," the Presenter said, and read the ranking that placed filling-and-sealing batch records at number one on the top-10 list. In OPMA——s keyword summary the Presenter reported filling accounted for roughly 20% of keyworded deficiencies and that, within filling-and-sealing, batch records and in-process controls each represented large shares (about 30% each by the Presenter——s account).
The Presenter gave practical guidance for applicants: ensure batch formulas include processing aids when applicable, establish and document IPCs for commercial manufacturing (for example, for an ABC assay), and provide supporting data such as lyo-cycle graphs and evidence from exhibit batches where relevant. He also warned that omissions can prompt repeated information requests and slow approval timelines.
The Presenter concluded by advising manufacturers to make filling-and-sealing the first target for remediation to improve the likelihood of faster regulatory decisions.
