Japanese–English glossary
Adventitious agents
外来性因子gairaisei inshi
Microorganisms or other agents introduced unintentionally into a cell bank, raw material or product: viruses, bacteria, fungi, mycoplasma and the agents of transmissible spongiform encephalopathies. Biological materials make it impossible to rule them out entirely, so control combines sourcing of raw materials, cell bank testing, testing of unprocessed bulk and validated virus clearance (ICH Q5A). In Japan, materials of human or animal origin must also meet the Standard for Biological Ingredients, which sets, for example, permitted countries of origin for ruminant-derived materials.