Standard operating procedure (SOP)

A written procedure that tells staff how to carry out a specific task. Japanese sites use the abbreviation alongside the native word for procedures (手順書), which is also the word the GMP Ministerial Ordinance uses for the written procedures it requires, for example for change control, deviations and batch disposition. Japanese GMP also has a product-specific master document (製品標準書) that collects the approved manufacturing method, specifications and other product information; it is not an SOP. Inspectors check both that the SOP exists and that people follow it. A foreign site supplying Japan should make sure its SOPs include Japan-specific steps, such as informing the MAH before a change.