Staying on top of regulatory standards is a must in pharmaceuticals, biotech, and medical devices. When quality issues pop up, companies turn to Corrective Action and Preventive Action better known as CAPA. It’s not just a checkbox, either. CAPA forms the foundation of quality management systems, and regulators everywhere expect to see it in action.
A methodical procedure called Corrective Action and Preventive Action (CAPA) is used to find, look into, and fix quality-related problems.
- Eliminating the underlying cause of an existing issue or non-conformance is the main goal of corrective action.
- Eliminating a problem’s possible cause before it arises is the goal of preventive action.
- When combined, CAPA guarantees both regulatory compliance and ongoing improvement.
When Is CAPA Required?
Usually, CAPA is started in reaction to:- Regulatory examinations and audit conclusions
- Non-conformances and deviations
- Consumer grievances
- Trends of adverse events
- Out-of-specification (OOS) outcomes
CAPA is required under regulations such as ICH Q10, FDA 21 CFR, EU GMP, and ISO standards.
Key Steps in the CAPA Process
Identification of Issues Record quality events, audit results, or deviations. Analysis of Root Causes Utilizing techniques like Fishbone diagrams and the Five Whys to determine the root causes. Planning and Execution of Action Establishing precise roles and deadlines for corrective and preventive measures. Evaluation of Effectiveness Confirming that the problem has been fixed and that it won’t happen again.Importance of CAPA in Regulatory Compliance
An effective CAPA system demonstrates a company’s commitment to quality, risk management, and continuous improvement. Poor CAPA management is a common cause of regulatory observations and warning letters.
How Masuu Global Supports CAPA Management
Masuu Global helps businesses maintain inspection-ready quality systems by offering professional assistance with CAPA development, remediation, documentation, and regulatory readiness.