CORRECTIVE AND
PREVENTIVE ACTION
PRESENTED BY : AKASH YADAV
M PHARMA 1st YEAR
SGT COLLEGE OF PHARMACY
WHAT IS CAPA ?
• • CAPA stands for Corrective and Preventive Action.
• • It is a key element of Pharmaceutical Quality Management Systems
(QMS).
• • Purpose: To identify, investigate, and eliminate causes of non-
conformities and prevent recurrence.
OBJECTIVE OF CAPA
• • Ensure product quality, safety, and efficacy.
• • Eliminate root causes of deviations or failures.
• • Promote continual improvement.
• • Maintain compliance with regulatory standards (FDA, WHO, EMA).
TYPES OF CAPA
• 1. Corrective Action: Actions taken to eliminate the causes of
detected non-conformities.
• Example: Investigating and fixing a failed batch.
• 2. Preventive Action: Actions taken to eliminate the causes of
potential non-conformities.
• Example: Implementing training or process improvement.
STEPS OF CAPS
CAPA WORKFLOW IN PHARMA
• 1. Identification of issue (Deviation, Complaint, Audit finding, etc.)
• 2. Evaluation and risk assessment.
• 3. Root Cause Analysis (RCA).
• 4. Implementation of Corrective and/or Preventive Action.
• 5. Effectiveness verification.
• 6. Documentation and closure.
SOURCES OF CAPA
• • Deviation Reports
• • Internal/External Audits
• • Product Complaints
• • Stability Failures
• • Change Control
• • Supplier Quality Issues
• • Regulatory Inspections
CORRECTIVE ACTION PROCESS
• • Identify immediate correction to contain the problem.
• • Define corrective steps to remove root cause.
• • Implement process changes or retraining.
• • Document and review implementation results.
Preventive Action Process
• • Analyze trends and risk data.
• • Identify potential areas of failure.
• • Develop preventive measures such as SOP revisions, automation, or
training.
• • Monitor outcomes to ensure effectiveness.
REGULATORY EXPECTATIONS
• • WHO GMP: Requires investigation and documentation of deviations
and corrective actions.
• • FDA 21 CFR Part 211: Emphasizes CAPA in quality systems.
• • ICH Q10: Integrates CAPA within Pharmaceutical Quality System.
• • EMA: Requires continual improvement through CAPA.
DOCUMENTATION IN CAPA
• • CAPA record must include:
• - Problem description
• - Investigation report
• - Root cause analysis
• - Actions taken
• - Verification results
• - Closure approval
• • Must be traceable and auditable.
CHALLENGES IN CAPA IMPLEMENTATION
• • Poor root cause identification.
• • Inadequate documentation.
• • Lack of management support.
• • Delayed implementation.
• • Failure to verify effectiveness.
• • Overlapping responsibilities.
BEST PRACTICE FOR EFFECTIVE CAPA
• • Encourage a quality culture.
• • Train personnel regularly.
• • Use data-driven decision-making.
• • Ensure timely closure of CAPA.
• • Link CAPA with risk management and continuous improvement.
MAJOR KEY POINTS
• Proper strategy
• Excetive management
• QA receive progress report
• Site Meeting
• Training
• Management delegates someone to drive capa
resolution
CONCLUSION
• • CAPA is a critical component of quality assurance in pharma.
• • Effective CAPA ensures compliance, prevents recurrence, and
promotes continuous improvement.
• • A well-implemented CAPA system strengthens regulatory trust and
product reliability.
“Quality is never an accident; it is always the result of
high intention, sincere effort, intelligent direction and
skilful execution . it represents the wise choice of
many alternatives.
William A. Foster
THANK YOU
