Japanese–English glossary
Viral safety evaluation
ウイルス安全性評価uirusu anzensei hyōka
The overall case that a biological product made in animal or human cells is free of infectious viruses. ICH Q5A builds it on three complementary elements: selecting and testing cell lines and raw materials, testing unprocessed bulk and intermediates for adventitious and endogenous viruses, and demonstrating that the purification process removes or inactivates viruses. Its revision, ICH Q5A(R2), updated the testing approaches and product scope. Japanese CMC documents follow the same structure, and materials of human or animal origin add a sourcing review under Japan's Standard for Biological Ingredients.