Corrective and Preventive Action (CAPA) is a quality system process used to investigate, correct, and prevent the recurrence of quality issues such as deviations, complaints, audit findings, or inspection observations.
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Corrective Action: Addresses the cause of an existing problem to prevent recurrence.
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Preventive Action: Addresses the potential cause of a possible problem to prevent occurrence.
⚙️ Step-by-Step Implementation of CAPA in Pharmaceuticals
1. Identification of the Issue
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Source of issues: Deviation reports, out-of-specification (OOS) results, audit findings, complaints, product recalls, trend analyses.
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Record the issue in a CAPA log or quality management system (QMS).
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Assign a unique CAPA reference number for tracking.
Tools: Deviation reports, complaint logs, quality risk management data.
2. Evaluation and Risk Assessment
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Determine the impact of the issue on product quality, safety, efficacy, and compliance.
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Use Quality Risk Management (QRM) principles as per ICH Q9.
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Classify the issue based on severity, frequency, and detectability (e.g., using risk matrix).
Goal: Decide if a full CAPA process is necessary or if a simpler fix suffices.
3. Investigation and Root Cause Analysis
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Perform a thorough root cause analysis (RCA) to identify why the issue occurred.
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Use structured methods:
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5 Whys
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Fishbone Diagram (Ishikawa)
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FMEA (Failure Mode and Effects Analysis)
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Tip: Focus on systemic causes, not just symptoms.
4. Develop Corrective and Preventive Actions
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Corrective Action: Fix the root cause and any affected product, process, or system.
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Examples: retraining, updating SOPs, equipment repair, software validation.
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Preventive Action: Modify systems to prevent future occurrences.
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Examples: design changes, policy changes, increased monitoring, automation.
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Ensure actions are measurable, realistic, and time-bound.
5. Implementation of Actions
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Assign responsibilities and deadlines.
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Update SOPs, documentation, and training records as required.
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Implement the changes in production or quality systems.
All changes must follow change control procedures per GMP.
6. Effectiveness Check
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After implementation, verify that the CAPA was effective in eliminating the root cause.
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Methods:
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Repeat audits or inspections
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Trend analysis
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Batch reviews or product re-testing
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If ineffective, revisit the root cause or modify the action plan.
7. Documentation and Closure
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Document all stages: identification, investigation, actions, and effectiveness check.
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Use CAPA forms or electronic QMS platforms.
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Ensure QA review and final approval before closing CAPA.
Retain CAPA documentation for regulatory inspections and audits.
