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CAPA stands for Corrective and Preventive Action, and is a quality management system that involves identifying, analyzing, correcting, and preventing issues. It’s an important part of a pharmaceutical company’s quality management system, and helps to prevent problems from recurring.
CAPA is critical to the success of the pharmaceutical industry, and is used to mitigate non-conformances that arise during production or in the field.
CAPA systems must be implemented for handling Complaints, Product rejections, Non conformances, and Recalls.
Step-by-step overview of the CAPA process
Issue Investigation
Once an issue is identified, a thorough investigation is conducted to determine its root cause(s). This typically involves gathering data, analysing process parameters, conducting laboratory tests, and reviewing documentation to understand why the issue occurred.
Root Cause Analysis (RCA)
Root cause analysis is a critical step in the CAPA process. It involves systematically identifying the underlying factors or systemic weaknesses that contributed to the quality issue or deviation. Common tools and techniques used for RCA include Fishbone diagrams, 5 Whys, Fault Tree Analysis, and Failure Mode and Effects Analysis (FMEA).
Corrective Action (CA)
Based on the findings of the root cause analysis, corrective actions are developed and implemented to address the immediate issue and prevent its recurrence. Corrective actions may involve process adjustments, equipment repairs, procedural changes, or additional training for personnel.
Preventive Action (PA)
In addition to addressing the immediate issue, preventive actions are identified and implemented to eliminate or mitigate potential future risks. Preventive actions aim to strengthen processes, systems, or controls to prevent similar issues from occurring in the future.
CAPA Plan Implementation
Once corrective and preventive actions are developed, they are implemented according to a predefined CAPA plan. This plan outlines specific actions, responsibilities, timelines, and milestones for implementation.
Verification and Effectiveness Monitoring
After implementing corrective and preventive actions, their effectiveness is monitored and verified to ensure that they have successfully addressed the identified issues and prevented their recurrence. This may involve follow-up inspections, performance monitoring, trending analysis, and periodic reviews of CAPA effectiveness.
Documentation and Reporting
All CAPA activities, including issue identification, investigation, root cause analysis, action plans, and verification activities, are documented in detail.
