International Journal of Pharmaceutical Investigation, 2023, 13, 2, 224-230.
DOI: 10.5530/ijpi.13.2.030
Published: March 2023
Type: Review Article
Authors:
Shantanu S Thakre
Department of Pharmaceutics, Pharmaceutical Regulatory Affairs Group, JSS College of Pharmacy, JSS Academy of Higher Education and Research, Mysuru, Karnataka, INDIA.
MP Venkatesh
Department of Pharmaceutics, JSS College of Pharmacy, JSS Academy of Higher Education and Research, SS Nagar, Mysuru, Karnataka, INDIA and Guest Assistant Professor, Faculty of Pharmaceutical Sciences, UCSI University, Kaula Lampur, MALAYSIA.
Rohit S Gahilod
Department of Pharmaceutics, Pharmaceutical Regulatory Affairs Group, JSS College of Pharmacy, JSS Academy of Higher Education and Research, Mysuru, Karnataka, INDIA.
ABSTRACT
Corrective and Preventive Actions (CAPA) are crucial for enhancing and raising the quality of the finished good or service. It is essential to every industry’s ongoing development. In any pharmaceutical or medical device sector, the main goal of Corrective Action and Preventative Action (CAPA) is to identify any weaknesses, deviations, or failures and conduct an inquiry, and take the necessary corrective action to ensure that these issues don’t recur. An approach known as CAPA also entails taking preventive actions right away to stop any incidence from happening in the first place. In a pharmaceutical company, it is both a legal necessity and a component of the broader Quality Management System (QMS). The corrective and preventive action subsystem is governed by 21 CFR 820.100, which lays out the rules (CAPA).
Keywords: CAPA, Corrective action and Preventive action, Corrective action, Preventive action.