Whenever there is a need to address quality-related issues CAPA is initiated, examples of quality-related issues include deviations, non-conformances, market complaints, deficiency during internal audits, product recalls, etc. CAPA aims to address the issue in such a way that, there is no such occurrence in the future. CAPA is an important aspect of GMP & Regulatory compliance.

CAPA – CORRECTIVE & PREVENTIVE ACTION Is a systematic approach for resolving quality-related issues in the pharmaceutical industry or any other industry that needs to solve the issues and improve the quality of the products they produce.

Corrective Actions (CA): It is the immediate action taken to correct the issue and prevent its occurrence. These actions are taken to eliminate the root cause(s) of an existing issue or deviation.

Preventive Actions (PA): These are Foresighted measures taken to prevent issues or nonconformances occurring in the future.  Preventive actions are taken based on past experiences, risk assessments, and as a part of continuous improvement of the process.

Steps for a successful CAPA

1. Issue Identified – If the Product or process fails to meet the requirements and there is a high risk, then we need to initiate CAPA
2. Initiation- CAPA is formally initiated according to the company process either through CAPA form or through the QMS system.
3. Investigate the root cause – This can be done by collecting the data related to the issue by checking batch records and use of techniques like the 5why technique, fishbone diagram, etc. to find the root cause of the problem.
4. Impact Identification – Identify the impact of the issue or non -non-conformance on the product quality, and regulatory adherence, this will give an idea of what corrective actions should be taken
5. Implement Corrective action – Correct the issue by enhancing the process by making necessary corrections, wherever required, training personnel on the changes made, and taking necessary quality measures.
6. Implement preventive action to prevent future occurrence of the issue
7. Verify the effectiveness of CAPA – A CAPA effectiveness check should be done by monitoring the implemented corrective and preventive actions and ensuring that the process runs smoothly without the reoccurrence of the resolved issue.
8. Document all the CAPA activities in CAPA form or record.