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

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Current effective version

Adopted guideline

Reference numberCPMP/ICH/294/95
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

Adopted guidelineIn operation: 31/03/1998–present
Superseded documentAdopted guidelinePublished: 31/12/1994

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