Innovation in the pharmaceutical industry doesn’t stop with the medicines themselves. Manufacturers must also examine processes, facilities, and the supply chains for opportunities to ensure the most efficient production and delivery of drugs to patients. One such innovation that sparks the imagination of regulators and industry alike is Distributed/Decentralized Manufacture (DM). In DM the traditional model of a single, large capacity manufacturing site with a large complex distribution network, is transformed to encompass multiple, highly similar manufacturing sites, across different locations or regions. In this Expert Xchange we bring together all who have a stake, to share the latest regulatory positions and pathways to enable DM, and discuss the remaining challenges, including proposals for how one might take a risk-based approach to DM.
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