An Overview on Corrective Action and Preventive Action Regarding Pharmaceutical Industry
Year: 2025
Type: article
Abstract: The pharmaceutical industry enforces strict rules to ensure the safety and quality of medicines. One crucial aspect of these rules is the Continuous Actions (CAPA) system, which aims to fix and prevent problems in the production of medicines and medical devices. This paper explains the importance of CAPA, highlighting its benefits, including improved medicines, reduced legal issues, and increased trust in the company. However, setting up CAPA can be challenging due to the complexity of the rules, limited resources, and resistance to change. The paper proposes a step-by-step approach, focusing on a strong quality system, maintaining good records, and regularly checking the effectiveness of CAPA. In the USA, CAPA rules are outlined in 21 CFR 820.100.
Author: Shailesh Solanke*, Pawan Survase, Gauri Solanke, Pratiksha Sonawane, Siddhi Shinde
Language: English
Topic: Healthcare Regulation
Subfield: Health Information Management
Field: Health Professions
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W6930730540
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