Overview
ISO 21973:2020 - Biotechnology - General requirements for transportation of cells for therapeutic use - defines high-level requirements and points to consider for transporting human cells and tissues intended for therapeutic use. The standard covers the transportation phase that begins when packaged cells are handed to the transportation service provider and ends on delivery to the receiver. It applies to autologous and allogeneic cells and focuses on planning, communication, documentation, verification and validation, and maintaining product quality during transport. Note: ISO 21973:2020 does not apply to intra‑facility movement and does not prescribe specific container designs, temperature setpoints or shipping hardware.
Key Topics
The standard addresses practical and technical topics central to safe, compliant cell transportation:
- Transportation plan: development of a formal plan including objectives, roles, responsibilities and acceptance criteria.
- Risk management: risk assessment and risk control covering transport hazards that could affect cell quality, safety and efficacy.
- Verification and validation: proving transportation processes and systems deliver intended conditions and outcomes.
- Chain of custody & traceability: documenting custody, tracking samples and maintaining records throughout transport.
- Shipping container and labelling best practices: guidance on container systems, label content and physical label requirements (standard does not set specific container specs).
- Operational procedures: shipment preparation, monitoring during transit, inspection at delivery, and handling exceptional events and incidents.
- Organization & personnel: supplier qualification, training plans, and quality management system (QMS) considerations.
- Storage facility considerations and documented information requirements.
Applications - Who Should Use It
ISO 21973:2020 is intended for organizations involved in the cell therapy supply chain, including:
- Cell therapy manufacturers and clinical production laboratories
- Transportation service providers and logistics companies handling biological shipments
- Hospital pharmacies and clinical sites receiving cell therapy products
- Quality assurance, regulatory and compliance teams establishing transport SOPs
- Contract development and manufacturing organizations (CDMOs) and 3PLs
Use cases include supplier qualification, creating validated transportation processes, improving chain-of-custody controls, and integrating transport requirements into QMS documentation.
Related Standards
- ISO 13022:2012 (contains guidance for transport of human cells; referenced in ISO 21973:2020)
- ISO/TC 276 (technical committee responsible for biotechnology standards)
Keywords: ISO 21973:2020, cell transportation, cells for therapeutic use, chain of custody, transportation plan, risk management, verification and validation, traceability, shipping container, labelling, QMS.