ICH Q5A
ICH Q5A(R2) — Viral Safety Evaluation of Biotechnology Products · viral safety guideline
ICH guideline on viral safety for biotech products derived from human or animal cell lines — testing, clearance studies, and risk assessment.
ICH Q5A defines a three-tier approach to viral safety for biologics made in cell culture: characterisation of cell-line and raw-material viral risk, in-process testing, and demonstration of viral clearance through dedicated downstream steps. The 2024 R2 revision expanded scope to advanced therapies and continuous bioprocessing.
V5 ties viral-clearance study results, raw-material certificates, and bioreactor lot genealogy into a single biologics dossier surfaced at batch release.
- ICH Q5A(R2)
Free trial, no credit card, onboard in days, not months.