ABSTRACT
Fundamentally, there are two ways to deal with or handle problems: the first one is to have a corrective approach, and the second is to have a prevention strategy. The corrective approach has many methodologies and tools that may be used. Some of them are indicative of the core business strategy of an organization. Action taken to prevent the recurrence of the present problem, similar problems and systemic problems. Corrective action is incomplete without preventive actions. In the health and pharmaceutical industries, a specific corrective and prevention methodology is used to meet the government requirements of FDA 21 CFR 820.100, and this methodology is known as corrective action and preventive action (CAPA). Verification of CAPA system procedure(s) that addresses the requirements of the quality system regulation. It must be defined and documented. CAPA process actions are effective and verified or validated prior to implementation.
