Drug product (DP)

The finished dosage form: drug substance combined with excipients, filled into its container closure system and, where relevant, freeze-dried. For biologics, drug product manufacturing usually means formulation, sterile filtration, aseptic filling, inspection and packaging. The Japanese word also means 'formulation' or 'preparation' in a general sense, so context decides. Japanese CMC documents follow the CTD structure, with separate drug substance and drug product sections in Module 3. Problems that start upstream, such as residual host cell protein or aggregation, often show up only at the drug product stage.