Category
Implementation Guide
ID
ICCBBA IG-050
Type
Standard
Version
1.0.0
Access
Open
Status
Active
Created
December 2023
This implementation guide is a supplement to the ISBT 128 standard technical specification. It provides guidance for cellular therapy collection and manufacturing facilities in the use of the Chain of Identity Identifier Data Structure [040] and the Chain of Identity Identifier data element ChainOfIdentityIdentifier in compliance with ISBT 128 Standard Chain of Identity (CoI) Identifier (ST-028). The CoI Identifier is used to communicate across the supply chain and maintain the chain of custody over medical products of human origin (MPHO).
Main sections:
- Introduction
- Using the CoI Identifier to link collection(s) associated with a given therapy
- Assignment of the CoI Identifier by an entity
- Using the CoI Identifier on a non-ISBT 128 label
- Becoming a CoI Identifier issuing organisation
- Electronic transmission of the CoI Identifier
- Sample MPHO product XML elements using the ISBT 128 CoI Identifier
Main sections:
- Introduction
- Using the CoI Identifier to link collection(s) associated with a given therapy
- Assignment of the CoI Identifier by an entity
- Using the CoI Identifier on a non-ISBT 128 label
- Becoming a CoI Identifier issuing organisation
- Electronic transmission of the CoI Identifier
- Sample MPHO product XML elements using the ISBT 128 CoI Identifier