ISPE Quality Management System Standard Operating Procedure Template: CAPA Management

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$500.00

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$850.00

Published: July 2025
Pages: 12

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Corrective Action and Preventive Action (CAPA) is a critical component of the Quality Management System (QMS) and is essential for ensuring compliance with regulatory requirements such as current Good Manufacturing Practices (cGMP), as well as maintaining safety, efficacy, and quality of pharmaceutical products. The CAPA process aims to address both the root causes of identified non-conformances and deviations and to implement measures that prevent recurrence.

This Standard Operating Procedure (SOP) includes a template that defines the process for the identification, documentation, evaluation, and resolution of quality issues through CAPA within a pharmaceutical company’s operations to ensure quality issues are systematically resolved and that corrective actions and preventive actions are tracked, evaluated, and closed in accordance with regulatory guidelines and internal quality standards.

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