Japanese–English glossary
Starting material
Also called raw material
出発原料shuppatsu genryō
Also written 原材料
A material that enters manufacturing at its beginning and becomes part of, or contributes to, the drug substance. For small molecules, the API starting material marks where GMP begins (ICH Q7 and Q11). For biologics and cell therapies, the term covers cell banks, donor cells, plasmids and other biological inputs. Japanese documents also use a broader word for raw materials (原材料). Materials of human or animal origin must conform to Japan's Standard for Biological Ingredients (MHLW Notification No. 210 of 2003), which also covers materials used in manufacturing as additives and culture medium components.