Skip to main content
Category
Implementation Guide
Standard
ICCBBA IG-050
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
Access Implementation guide: Using the ISBT 128 Chain of Identity (CoI) identifier v1.0.0

By accessing this content, you are leaving this website. The Agency takes no responsibility for the accuracy of content on the destination page.