ICH Q5D Derivation and characterisation of cell substrates used for production of biotechnological/biological products

Current effective version

PDF iconAdopted guideline

Reference numberCPMP/ICH/294/95
Published31/03/1998
Effective from31/03/1998
KeywordsCell bank, master cell bank, working cell bank, cell line, biotechnological product, biological product, identity, purity, stability, tumourigenicity
DescriptionThis document provides guidance on standards for the derivation of human and animal cell lines and microbial cells to be used in biotechnological/biological products. It outlines recommendation for the preparation and characterisation of cell banks to be used for production.


Document history

First version

Current version

PDF iconAdopted guideline In operation: 31/03/1998–present
Superseded document PDF iconAdopted guideline Published: 31/12/1994


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