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

PDF iconRevision 1 - Adopted guideline

Reference numberCPMP/ICH/295/95
Published01/03/1997
Effective from01/10/1997
KeywordsViral safety, cell lines qualification, biotechnology, virus clearance
DescriptionThis 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.


Related content


How useful was this page?

Add your rating