Q5D: Derivation and Characterisation of Cell Substrates Used for Production of Biotechnological/Biological Products

Regulatory Resource: Q5D: Derivation and Characterisation of Cell Substrates Used for Production of Biotechnological/Biological Products

Description:

The tripartite harmonised ICH guideline was finalised (Step 4) in July 1997. This document provides broad guidance on appropriate standards for the derivation of human and animal cell lines and microbes used to prepare biotechnological/biological products and for the preparation and characterisation of cell banks to be used for production.

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