CAPA

Corrective and Preventive Action (CAPA) was first formally introduced by the U.S. FDA in 2006 as a component of the Quality Systems Guidance. This guidance would go on to form the basis of the ICH Guideline Q10. Since then, it’s found its way into the EU GMP Guide, laying out the CAPA process within the pharmaceutical space.

For medical device companies, CAPA is addressed in ISO 13485, which, unlike Q10, divides the concept into its two concepts: “Corrective measures” (addressed in Chapter 8.5.2 是正措置) and “Preventive measures” (addressed in Chapter 8.5.3 予防措置). Despite separating these processes, both must be documented and evaluated to demonstrate improvement and preventive action, making CAPA the practical process by which both are united. With this in mind, we’ll treat it as one concept here.