Steven Falcone

Andrew Chang and Steven Falcone, Novo Nordisk, explain how FDA-EU GMP mutual recognition and a robust internal signal process drive global regulatory compliance.

How Pharma Companies Navigate GMP Regulatory Inspections

Andrew Chang, senior Director for Quality and Regulatory Affairs, Novo Nordisk, and Steven Falcone, head of the AIR-Q group, Novo Nordisk, discuss how their company navigates the evolving landscape of international GMP regulatory compliance.

Chang explains that the FDA-EU GMP mutual recognition framework allows the two regulatory bodies to recognize each other's GMP inspections, a mechanism primarily used for surveillance inspections but also applied on occasion to pre-license and pre-approval inspections. Falcone adds important context about Novo Nordisk's global manufacturing footprint, noting that the company has significant operations in Denmark, which means European inspections conducted there are frequently leveraged by the FDA under the mutual recognition arrangement.

They discuss how Novo Nordisk maintains compliance across its global network. Falcone describes the company's internal signal-monitoring process, which tracks changes in regulation, industry developments, and guidance documents. "That signal process includes changes in regulation, changes in industry, guidance documents, and of course, 483s and any other kind of observations that occur within our own network," Falcone explaind.

When a regulatory finding is identified at one site, Novo Nordisk uses cross-functional focus groups to evaluate whether similar gaps exist elsewhere in the network, a proactive approach to systemic risk management. As Falcone puts it, "Those groups will evaluate a regulatory finding from one site against the entire network for any other gaps in those local sites."

Steven Falcone

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