Corrective and Preventive Actions (CAPA) – is systematic approach to identifying, addressing, and preventing issues or non-conformities that may arise during the conduct of a clinical trial.
Definitions
ISO 9000:2015 Quality management systems
- 3.12.2 corrective action:
- action to eliminate the cause of a nonconformity (3.6.9) and to prevent recurrence [1].
- 3.12.1 preventive action:
- action to eliminate the cause of a potential nonconformity (3.6.9) or other potential undesirable situation [1].
Goals of CAPA
Corrective actions are steps taken to eliminate the root cause of an existing issue or non-conformity. These actions aim to resolve the immediate problem and prevent its recurrence in the future.
Preventive actions, on the other hand, are proactive measures implemented to prevent the occurrence of issues in the first place. These actions are based on risk assessment and aim to mitigate risks before they lead to problems.
CAPA processes
CAPA is an essential component of quality management in clinical studies, ensuring that trials are conducted in compliance with regulations, protocols, and quality standards, thereby maintaining the integrity and validity of study data. CAPA typically includes:
- Identification of issues or non-conformities through quality control measures, audits, inspections, or other monitoring activities
- Investigation to determine the root cause of the issues
- Development and implementation of corrective actions to address the root cause and resolve the issue
- Implementation of preventive actions to reduce the probability of similar issues occurrence in the future
- Monitoring and verification of the effectiveness of the actions taken
See also
Another relevant pages
Links to this page
- Quality assurance (← links)
- Corrective and Preventive Actions (redirect page) (← links)
- CAPA (redirect page) (← links)
References
- ↑ 1.0 1.1 ISO, 2015, ISO 9000:2015 Quality management systems – Fundamentals and vocabulary, https://www.iso.org/obp/ui#iso:std:iso:9000:ed-4:v1:en:term:3.3.7 Accessed May 2024
External links
- FDA, 1999, Guide to Inspections of Quality Systems, Corrective and Preventive Actions (CAPA) https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-guides/corrective-and-preventive-actions-capa Accessed May 2024
- "The FDA group" blog, 2023, Corrective and Preventive Action (CAPA): The Definitive Guide https://www.thefdagroup.com/blog/definitive-guide-to-capa Accessed May 2024