Revolutionizing Drug Manufacturing: A Closer Look At Pending Facility Applications For GMP Inspections

By Connie Leech and Geraldine Carr-Mulry

The pharmaceutical supply chain vulnerabilities and challenges exposed by the COVID-19 pandemic resulted in widespread drug shortages and disruptions. Although certain aspects of the pandemic have subsided, drug shortages have persisted on a global scale. The demand for flexibility in supply chains remains imperative, yet many drug manufacturers hesitate to make significant changes to their processes and facilities due to regulatory hurdles, differing expectations, and implementation timelines that may be imposed by global regulatory changes.

Fortunately, regulatory bodies have recognized the pressing need to fortify and streamline supply chains. Collaborative efforts among global regulators are underway to address challenges related to drug availability, with some promising initiatives currently in the pilot phase.