Corrective and Preventive Actions (CAPAs) are critical elements within a quality management system (QMS).
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According to the FDA website, the “purpose of the corrective and preventive action subsystem is to collect information, analyze information, identify and investigate product and quality problems, and take appropriate and effective corrective and/or preventive action to prevent their recurrence.”
When an FDA investigator inspects a GMP site, they expect to see a robust CAPA process integrated within the QMS. Lack of an effective CAPA process can result in 483 observations and other enforcement actions.
Want to learn more about building a robust CAPA process? Here are some carefully curated articles on the topic:
- Can Quality Culture Prevent GMP Issues Such as Data Integrity?
A good CAPA program requires a strong quality culture within an organization: an industry leader covers how quality culture relates to data integrity.
- Process Capability in Focus in FDA Device Inspections
Measuring how a manufacturing process consistently produces a product that meets specifications is critical. Failing to implement CAPAs greatly impacts process capability.
- ORA Targets CAPA Effectiveness Check Deficiencies
Find out why FDA Office of Regulatory Affairs field investigators are following up on CAPAs with appropriate effectiveness checks.
- FDA Takes Quality Systems Approach to CGT Inspections
Problematic CAPAs are some of the 483 observations related to quality systems seen by FDA investigators at cell and gene therapy manufacturing sites.
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