ICH Q5D Derivation and Characterisation of Cell Substrates Used For Production of Biotechnological/Biological Products
Title:
ICH Q5D Derivation and Characterisation of Cell Substrates Used For Production of Biotechnological/Biological Products
Origin/Publisher:
Document Type:
ICH Guideline
Content:
This guideline 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.