Chain of Custody

Chain of Custody refers to the documented process of tracking the handling, transfer, storage, and processing of materials or samples to ensure traceability, integrity, and accountability throughout their lifecycle. In biopharma, this concept applies to clinical trial samples, manufacturing raw materials, drug substances, and advanced therapy products, particularly where identity preservation is essential. Chain of custody records typically include timestamps, personnel identifiers, storage conditions, and transfer documentation ensuring that every handoff is verifiable.

The biopharmaceutical industry treats chain of custody as a core requirement for quality assurance and regulatory compliance, especially for patient-specific therapies such as autologous cell treatments. Breakdowns in traceability can lead to severe consequences including sample mix-ups, invalidated trial data, or patient safety risks. Robust chain of custody systems integrate barcode tracking, electronic records, temperature monitoring, and controlled access procedures. Regulatory inspections often review chain of custody documentation to confirm adherence to Good Clinical Practice and Good Manufacturing Practice expectations. As personalised medicine expands and supply chains become more distributed, chain of custody frameworks continue strengthening through digital tracking technologies and end-to-end visibility models supporting secure, compliant product journeys.