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CDER: coating controls, membrane defects and sampling gaps found in transdermal submissions
Summary
Presenters said reviewers frequently encounter undefined critical coating parameters, inadequate coat‑weight sampling and missing defect assessments for rate‑controlling membranes; they urged comprehensive defect analysis and justified sampling to ensure dose control.
Kokate told attendees that the coating or serial operation is ‘‘probably the most critical’’ unit operation for TDS and is a frequent source of deficiencies. He said CPPs such as line speed, zone temperature and airflow are often not defined or are left as "TBD" in batch records and should instead be set and justified using development studies.
He also pointed to coat‑weight sampling problems and shortcomings in defect assessment for rate‑controlling membranes, warning that pinholes or tears could cause dose‑dumping. "If that happens, the defect should be identified and the root cause should be addressed in your package," he said. The presenter recommended sampling that covers the entire coating line and adequate sample counts to characterize variability across rolls.
