ICH Q5A (R1) Quality of biotechnological products: viral safety evaluation of biotechnology products derived from cell lines of human or animal origin
| Current effective version |
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| Reference number | CPMP/ICH/295/95 |
| Published | 01/03/1997 |
| Effective from | 01/10/1997 |
| Keywords | Viral safety, cell lines qualification, biotechnology, virus clearance |
| Description | This document considers testing and evaluation of the viral safety of biotechnology products derived from characterised cell lines of human or animal origin. It outlines data that should be submitted in the marketing application/registration package. |
