Traceability is the ability to track and document the complete history, origin, location, and application of a biological product, raw material, starting material, or manufacturing component throughout the entire supply chain and product lifecycle — from raw material sourcing through manufacturing, quality control, batch release, and distribution to the patient. In GMP-compliant biomanufacturing, traceability is a fundamental regulatory requirement enforced by agencies such as the EMA and FDA, underpinning batch record integrity, deviation investigation, recall management, and audit readiness. For CDMOs manufacturing ATMPs, viral vectors, and cell therapies, robust traceability systems are particularly critical given the patient-specific nature of many autologous products and the stringent chain of identity (CoI) and chain of custody (CoC) requirements.
