Pharmaceutical CAPA Review and Effectiveness Check Checklist

CAPA systems are a cornerstone FDA and regulatory requirement for pharmaceutical manufacturers. This checklist guides systematic CAPA quality review ensuring root cause identification, corrective action adequacy, and effectiveness verification per ICH Q10 and 21 CFR requirements.

  • Industry: Pharmaceutical & Life Sciences
  • Frequency: Monthly CAPA Review / Per CAPA Closure
  • Estimated Time: 30-45 minutes
  • Role: QA Manager / Quality Director
  • Total Items: 34
  • Compliance: ICH Q10 Pharmaceutical Quality System Section 3.2, FDA 21 CFR 820.100 Corrective and Preventive Action (Medical Devices), FDA 21 CFR 211 cGMP Requirements for CAPA, EU GMP Chapter 1 Pharmaceutical Quality System, ISO 13485 Section 8.5.2 Corrective Action (Medical Devices)

Problem Investigation and Root Cause

Evaluate quality of root cause investigation.

  • Problem or nonconformance clearly described with scope defined?
  • Structured root cause analysis method used (5-Why, Fishbone/Ishikawa, FMEA)?
  • Root cause specific and actionable (not generic 'human error' without further analysis)?
  • Contributing factors identified in addition to root cause?
  • Similar products, processes, or batches assessed for same issue (breadth)?
  • Immediate or containment actions documented (batch hold, recall assessment)?

Corrective Actions

Evaluate adequacy of corrective actions.

  • Corrective actions directly address the identified root cause?
  • Corrective actions are specific, measurable, and time-bound?
  • Each corrective action has an assigned owner and due date?
  • SOPs, batch records, or other documents updated as part of corrective action?
  • Training on corrective actions performed and documented?
  • Evidence of corrective action completion on file (training records, updated SOPs, validation data)?

Preventive Actions

Evaluate preventive action scope and adequacy.

  • Preventive actions identified to prevent recurrence in other areas?
  • Preventive actions address broader scope beyond the single occurrence?
  • Risk assessment used to prioritize and scope preventive actions?
  • Preventive actions have owners and target completion dates?
  • Evidence of preventive action completion on file?

Effectiveness Check

Evaluate effectiveness check design and results.

  • Effectiveness check planned with specific criteria for success?
  • Effectiveness check timeframe appropriate to allow recurrence detection?
  • Effectiveness criteria specific and measurable (not subjective)?
  • Effectiveness check results documented?
  • Effectiveness check passed - no recurrence of original issue?
  • CAPA reopened if effectiveness check not passed?

Timeliness and Closure

Review CAPA timeliness and closure requirements.

  • CAPA target dates met or extensions formally approved?
  • Overdue CAPAs escalated to senior management?
  • Regulatory reporting assessed for serious defects or field safety issues?
  • CAPA closure requires QA approval?
  • Trend assessed - CAPA type contributing to systemic quality issue?

CAPA Program Metrics

Review CAPA program effectiveness metrics.

  • CAPA backlog within acceptable limits (not accumulating)?
  • CAPA recurrence rate below established threshold?
  • On-time completion rate meeting program target?
  • CAPA metrics reported at management review per ICH Q10?
  • CAPAs from regulatory observations tracked separately with priority?
  • Annual CAPA program assessment completed?

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Why Use This Pharmaceutical CAPA Review and Effectiveness Check Checklist?

This pharmaceutical capa review and effectiveness check checklist helps pharmaceutical & life sciences teams maintain compliance and operational excellence. Designed for qa manager / quality director professionals, this checklist covers 34 critical inspection points across 6 sections. Recommended frequency: monthly capa review / per capa closure.

Ensures compliance with ICH Q10 Pharmaceutical Quality System Section 3.2, FDA 21 CFR 820.100 Corrective and Preventive Action (Medical Devices), FDA 21 CFR 211 cGMP Requirements for CAPA, EU GMP Chapter 1 Pharmaceutical Quality System, ISO 13485 Section 8.5.2 Corrective Action (Medical Devices). Regulatory-aligned for audit readiness and inspection documentation.

Frequently Asked Questions

What does the Pharmaceutical CAPA Review and Effectiveness Check Checklist cover?

This checklist covers 34 inspection items across 6 sections: Problem Investigation and Root Cause, Corrective Actions, Preventive Actions, Effectiveness Check, Timeliness and Closure, CAPA Program Metrics. It is designed for pharmaceutical & life sciences operations and compliance.

How often should this checklist be completed?

This checklist should be completed monthly capa review / per capa closure. Each completion takes approximately 30-45 minutes.

Who should use this Pharmaceutical CAPA Review and Effectiveness Check Checklist?

This checklist is designed for QA Manager / Quality Director professionals in the pharmaceutical & life sciences industry. It can be used for self-assessments, team audits, and regulatory compliance documentation.

Can I download this checklist as a PDF?

Yes, this checklist is available as a free PDF download. You can also use it digitally in the POPProbe mobile app for real-time data capture, photo documentation, and automatic reporting.

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