What ICH Q5A(R2) Viral Safety Evaluation of Biotechnology-Derived Products 2024 - Viral Clearance Studies, Testing Strategy and Risk Assessment Framework requires
This regulation requires manufacturers of biotechnology-derived products to conduct viral clearance studies using validated methods to demonstrate removal or inactivation of potential viral contaminants, particularly for products derived from human or animal cell lines. Key requirements are specified in ICH Q5A(R2), Section 3.2 on viral clearance validation.
Pillar: Biotech & Genomics · Authority: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) · Version: 1.0.0 · Last updated:
Primary source: https://database.ich.org/
SHA-256 integrity: 8f0ce4f050b111447e4cacd8286d9a7a66c1405d14a37669b1cfce1ccde2c4eb
Primary Citations — 5 traced to source
- ICH Q5A(R2), Section 3.2 - Viral Clearance Studies: Demonstration of Removal and Inactivation
- ICH Q5A(R2), Section 3.3 - Selection of Spiking Agents (Model Viruses)
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