The purpose of this document is to provide a mechanism to validate software reading bar-coded labels. Regulatory and compliance staff, as well as software developers, may find this guidance document helpful when developing certain validation test plans.

The purpose of this document is to provide guidance to help users implementing standardized labeling of collection products for further manufacture in compliance with the ISBT 128 Standard Labeling of Collection Products for Cellular Therapy Manufacturing (ST-018)

The purpose of this document is to provide a toolbox of commonly used items essential for implementing ISBT 128. It also provides guidance and recommended steps for consideration when planning out one’s ISBT 128 implementation.

The purpose of this document is to provide guidance for the use of the Chain of Identity Identifier Data Structure [040] and the Chain of Identity Identifier data element ChainOfIdentityIdentifier in compliance with the ISBT 128 Standard Chain of Identity (CoI) Identifier (ST-028).

This document provides an overview of the ISBT 128 Standard and how it applies to cellular therapy products. It also describes the elements needed to achieve standardization and how the standard is used to encode information into machine-readable form.