CAPA stands for Corrective and Preventive Actions. It is an essential component of the quality management system in regulated companies in the life science sector.
CAPA refers to processes that have been developed to:
- Corrective actions: Identify, analyse and correct errors or deviations.
- Preventive actions: Proactively identify and eliminate possible causes of errors or deviations to avoid future problems.
| EU GMP Guidelines, Chapter 1.4 (xiv) | …An appropriate level of root cause analysis is applied during the review of non-conformances, suspected product defects and other issues. This can be determined by utilising quality risk management principles. In cases where the exact cause cannot be determined, consideration should be given to identifying and addressing the most likely cause(s). If a human error is suspected or identified as the cause, this should be justified, taking into account that it has been ensured that procedural or system-based errors, if any, have not been overlooked. Appropriate corrective actions and / or preventive actions (CAPAs) should be identified and taken in response to the review. The effectiveness of such actions should be monitored and evaluated in accordance with the principles of quality risk management. |
| ICH-Leitlinie Q10 zum pharmazeutischen Qualitätssystem 3.2 Elemente des pharmazeutischen Qualitätssystems | … Some of the elements described below may be required by regional GMP regulations. However, the Q10 model aims to improve these elements in order to promote the life cycle approach to product quality. These four elements are: – Process performance and product quality monitoring system – Corrective and preventive action (CAPA) system – Change management system – Process performance and product quality management review. |
| ICH-Leitlinie Q10 zum pharmazeutischen Qualitätssystem 3.2.2.System für Korrektur- und Präventivmaßnahmen (CAPA) | The pharmaceutical company should have a system in place to implement corrective and preventive actions resulting from the investigation of complaints, product rejections, non-conformities, recalls, deviations, audits, regulatory inspections and findings and trends from process performance and product quality monitoring. The investigation should follow a structured approach aimed at identifying the root cause. The effort, formality and documentation of the investigation should be commensurate with the risk in accordance with ICH Q9. The CAPA methodology should lead to product and process improvements and a better understanding of the product and process. |
| GHTF SG3 – Qualitätsmanagementsystem -Medizinprodukte – Leitfaden für Korrektur- und Vorbeugungsmaßnahmen und damit verbundene QMS-Prozesse | Corrective action Action to eliminate the cause of a detected nonconformity or other undesirable situation Note 1 There can be more than one cause of a nonconformity Note 2 Corrective action is taken to prevent recurrence, whereas preventive action is taken to prevent occurrence … Preventive action Action to eliminate the cause of a potential nonconformity or other undesirable situation. Note 1 There can be more than one cause for nonconformity Note 2 Preventive action is taken to prevent occurrence whereas corrective action is taken to prevent recurrence … |
