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FDA CDER staff outline common manufacturing deficiencies in complex drug dosage forms
Summary
CDER presenters reviewed frequent process weaknesses found in transdermal systems, dry‑powder inhalers and metered‑dose inhalers, urging sponsors to provide development‑backed critical process parameters, in‑process tests and sampling plans to reduce review cycles.
Amit Kokate of the Office of Pharmaceutical Manufacturing Assessment at the FDA’s Center for Drug Evaluation and Research said the presentation would examine recurring problems the agency has seen in complex dosage forms. "The topic of our presentation today is common manufacturing process deficiencies that we've observed for complex dosage forms," he said.
Kokate summarized TDS manufacturing steps (mixing, coating, drying, laminating, slitting and converting) and said a treemap compiled from about 16 applications over the last five years shows most process deficiencies cluster in coating and mixing operations. He emphasized that sponsors should set justified critical process parameters (CPPs) based on development work and provide adequate in‑process controls and sampling strategies to demonstrate control and detect variability.
The presentation continued with dry‑powder and metered‑dose inhaler topics; presenters urged that submissions include specific sampling plans, calibration and verification details for net‑fill weight or blend uniformity tests, and theoretical plus empirical support for propellant compensation in MDIs. The presenters said stronger development evidence and sampling would reduce information requests and back‑and‑forth review cycles with FDA.
