Role of Corrective and Preventive action (CAPA) in Pharmaceutical Quality Management System

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

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Publication Details

Journal
International Journal of Advanced Research in Science Communication and Technology
Published
2025-09-22
DOI
https://doi.org/10.48175/ijarsct-28977
Primary Topic
Quality and Safety in Healthcare
Type
article
Field-Weighted Citation Impact
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article

Role of Corrective and Preventive action (CAPA) in Pharmaceutical Quality Management System

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Role of Corrective and Preventive action (CAPA) in Pharmaceutical Quality Management System

Maroti Deshmukh, Ms. Bhakti Santosh Gurav, Sachin Vitthal Datkhile, Ms. Komal Gaikwad, Mr. Omkar Rajaram Gosavi, Ms. Komal Naresh Aher
article en

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

International Journal of Advanced Research in Science Communication and Technology
Openalex Percentile: Top 53%
Quality and Safety in Healthcare
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