Role of Corrective and Preventive action (CAPA) in Pharmaceutical Quality Management System
Year: 2025
Type: article
Abstract: Corrective and Preventive Action (CAPA) forms an essential element of the Pharmaceutical Quality Management System (QMS). Its primary aim is to drive continuous improvement by systematically identifying, analyzing, correcting, and preventing quality issues in processes and products. This review explains the importance of CAPA within pharmaceutical QMS, covering regulatory perspectives, implementation approaches, common challenges, and overall benefits. It also highlights how CAPA strengthens compliance with Good Manufacturing Practices (GMP) and emphasizes the need for effective root cause analysis, proper documentation, and verification of outcomes to ensure success
Authors: Ms. Bhakti Santosh Gurav, Dr. Sachin V Datkhile, Ms. Komal Gaikwad, Mr. Omkar Gosavi, Ms. Komal Aher, Ms. Divya Deshmukh
Language: English
Subfield: Strategy and Management
Domain: Social Sciences
Open Access status: diamond
OpenAlex ID: W4414383909