This week, the FDA opened applications for its Expedited IND Pilot, quality experts presented at the PDA/FDA Joint Regulatory Conference, and Hovione expanded its spray drying capacity.
News|Articles|May 17, 2019
FDA Accepts TraceLink DSCSA Pilot Submission
Author(s)Pharmaceutical Technology Editors
TraceLink will participate in the agency’s Pilot Project Program under the Drug Supply Chain Security Act.
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TraceLink
The company’s project will include a diverse set of industry stakeholders such as large pharmaceutical manufacturers, biopharmaceutical companies, contract manufacturers, repackagers, wholesale distributors, retail pharmacy chains, healthcare systems, third-party logistics providers, and returns processors. It will also explore approaches to interoperable information sharing and verification and notification of patient safety.
The blockchain network solution will bring together end-to-end supply chain stakeholders to evaluate how blockchain can be used to meet DSCSA transaction information gathering requirements. It will leverage the company’s Trace Histories tool, a distributed ledger network, to develop a blueprint for industry “for an open, interoperable network to fulfill the requirements for a full unit level traceability across the supply chain,” the company stated.
The product recalls workstream will evaluate and enhance current recall verification and notification processes in the drug supply chain using lot level and serialization data on a digital supply-chain network. TraceLink stated in the press release that the current industry manual recall processes are time consuming and create inefficiencies. “In working toward the objectives of this workstream, pilot participants will evaluate different methods of effectively exchanging information on a network and coordinating with supply-chain partners to prevent recalled product from reaching patients,” the company stated.
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