Compliance

ICH Q5A

ICH Q5A(R2) — Viral Safety Evaluation of Biotechnology Products · viral safety guideline

In short

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.

Regulatory anchors

ICH Q5A(R2)

Where this term comes up

Pharmaceutical Blood & Tissue

How V5 handles it

eBMR / eDHR — the batch record fills in as the work is done.

When operators record their work at the step, the batch record no longer has to be assembled afterwards. People review it and decide release.

Related terms

ICH Q9 Donor eligibility ICH Q7 ICH Q6

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