Pharmaceutical Product Complaint Handling Checklist
Pharmaceutical product complaints are patient safety signals that require systematic investigation. This checklist ensures complaint handling processes comply with FDA 21 CFR 211.198 and EU GMP Chapter 8 requirements.
- Industry: Pharmaceutical & Life Sciences
- Frequency: Per Complaint / Monthly Review
- Estimated Time: 20-30 minutes
- Role: QA Manager / Regulatory Affairs Specialist
- Total Items: 31
- Compliance: FDA 21 CFR 211.198 - Complaint Files, FDA Guidance for Industry - Pharmaceutical Quality Systems, EU GMP Chapter 8 - Complaints, Quality Defects and Product Recalls, FDA Field Alert Report (FAR) Requirements 21 CFR 314.81
Complaint Receipt and Triage
Document complaint receipt and initial triage.
- Complaint recorded in complaint tracking system within required timeframe?
- Complaint source (patient, HCP, distributor, regulatory) documented?
- Medical evaluation for serious adverse event or injury potential completed?
- Complaint urgency classified (critical, major, minor) with timeline assigned?
- Complaint sample requested for testing if applicable?
Lot Traceability
Trace product to manufacturing records.
- Product lot number identified from complaint?
- Batch production record for complaint lot retrieved?
- Product distribution records reviewed for complaint lot?
- Retain samples of complaint lot retrieved for testing?
- Other potentially affected lots identified and assessed?
Complaint Investigation
Document investigation activities.
- Investigation documented with scope, findings, and conclusions?
- Retain or complaint sample testing performed per protocol?
- Manufacturing and QC records reviewed for complaint lot?
- Root cause determination completed or rationale for none documented?
- Related complaints searched and trended?
Regulatory Reportability Assessment
Assess regulatory reporting requirements.
- Field Alert Report (FAR) reportability assessed for US marketed products?
- If FAR required, filed within 3-day initial report timeframe per 21 CFR 314.81?
- Medical Device Report (MDR) assessed for combination products?
- EU Rapid Alert or Field Safety Notice assessed for EU marketed products?
- Product recall assessment completed?
CAPA and Closure
Complete complaint CAPA and closure.
- CAPA initiated if product defect or systemic issue confirmed?
- Response to complainant provided if applicable?
- Complaint investigation closed within required timeframe per SOP?
- Complaint data captured for APQR trending?
- Investigation report signed by QA and filed?
Monthly Complaint System Review
Monthly review of complaint system performance.
- All overdue open complaints reviewed and escalated?
- Complaint trends by product, category, and source reviewed?
- Complaint closure metrics meeting targets?
- No overdue FAR or regulatory notifications?
- Complaint handling team training current?
- Monthly complaint system review report prepared?
Related Pharmaceutical Life Sciences Checklists
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Why Use This Pharmaceutical Product Complaint Handling Checklist?
This pharmaceutical product complaint handling checklist helps pharmaceutical & life sciences teams maintain compliance and operational excellence. Designed for qa manager / regulatory affairs specialist professionals, this checklist covers 31 critical inspection points across 6 sections. Recommended frequency: per complaint / monthly review.
Ensures compliance with FDA 21 CFR 211.198 - Complaint Files, FDA Guidance for Industry - Pharmaceutical Quality Systems, EU GMP Chapter 8 - Complaints, Quality Defects and Product Recalls, FDA Field Alert Report (FAR) Requirements 21 CFR 314.81. Regulatory-aligned for audit readiness and inspection documentation.
Frequently Asked Questions
What does the Pharmaceutical Product Complaint Handling Checklist cover?
This checklist covers 31 inspection items across 6 sections: Complaint Receipt and Triage, Lot Traceability, Complaint Investigation, Regulatory Reportability Assessment, CAPA and Closure, Monthly Complaint System Review. It is designed for pharmaceutical & life sciences operations and compliance.
How often should this checklist be completed?
This checklist should be completed per complaint / monthly review. Each completion takes approximately 20-30 minutes.
Who should use this Pharmaceutical Product Complaint Handling Checklist?
This checklist is designed for QA Manager / Regulatory Affairs Specialist 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.