Corrective and preventive action (CAPA)

Actions that remove the cause of a detected problem (corrective action) and stop the same or a similar problem from occurring (preventive action). Japanese quality records use the abbreviation CAPA as often as the Japanese term. CAPA is triggered by deviations, out-of-specification results, complaints, audit and inspection findings, and product quality review, and it is one of the pharmaceutical quality system elements described in ICH Q10, whose concepts the 2021 revision of the GMP Ministerial Ordinance took in. A Japanese deviation report typically runs from the event to root cause analysis to CAPA and an effectiveness check. Reviewers look at whether the action removed the cause or only treated the symptom.