Having a robust corrective action and preventive action (CAPA) system in place is essential to ensure that the drug products are safe and effective. Inadequate CAPA procedures, however, continue to be a top compliance observation cited by FDA during inspections and warning letters.
CAPA started as an International Organization for Standardization (ISO) term and has been adopted by FDA as well as other global regulatory authorities. ICH Q10, a global guidance document from the International Conference on Harmonization (ICH) regarding quality systems for the pharmaceutical industry, has been adopted as the standard by most nations’ regulatory authorities. ICH Q10 defines the four elements of a pharmaceutical quality system: process performance and product quality monitoring system; CAPA system; change management system; and a process for management review of quality issues. Core to these four elements is the CAPA system, because this is the source of information for the other three.