EUGMP, Annex 16 require that for Medicinal products complete manufacturing and distribution chain to be documented as a comprehensive diagram and available for audits. For each drug product, this should map Excipients, Packing materials, Key components, APIs, GMP intermediates, their suppliers and Intermediaries like EU Importer, Warehouse, EU Testing labs, QP. Qvents post Supply Chain Traceability of Medicinal Products provides useful templates for Supply Chain Traceability Mapping and a tool for creating a Visual Map. (https://qvents.in/eugmp-eudralex-annexure16-supply-chain-traceability-mapping-tool/)
EUGMP, Annex 16 require that for Medicinal products complete manufacturing and distribution chain to be documented as a comprehensive diagram and available for audits. For each drug product, this should map Excipients, Packing materials, Key components, APIs, GMP intermediates, their suppliers and Intermediaries like EU Importer, Warehouse, EU Testing labs, QP. Qvents post Supply Chain Traceability of Medicinal Products provides useful templates for Supply Chain Traceability Mapping and a tool for creating a Visual Map. (https://qvents.in/eugmp-eudralex-annexure16-supply-chain-traceability-mapping-tool/)