Abstract

The primary objective behind corrective action and preventive action (CAPA) in any pharmaceutical or medical device industry is to determine the weakness, deviation or failures and to carry out its investigation with appropriate actions so that such problems are not repeated again. CAPA is also a method in which preventive measures are taken in the beginning itself so that occurrence of any incidence can be prevented. It is a part of overall Quality Management System (QMS) and also a regulatory requirement in a pharmaceutical company.

Keywords: Corrective action, preventive action, corrective action and preventive action (CAPA), action plan, root cause determination.