Pharmaceutical Product Recall Readiness Checklist
Pharmaceutical product recalls protect public health when a product is defective or potentially harmful. This readiness checklist ensures recall capabilities meet FDA 21 CFR Part 7 requirements and can be rapidly mobilized when needed.
- Industry: Pharmaceutical & Life Sciences
- Frequency: Annual
- Estimated Time: 30-45 minutes
- Role: Regulatory Affairs Manager / Quality Director
- Total Items: 31
- Compliance: FDA 21 CFR Part 7 - Enforcement Policy (Recalls), FDA 21 CFR 314.81 - NDA Post-Marketing Reports (Field Alerts), EU Regulation No. 726/2004 - Post-Authorization Safety Measures, ICH E2D Post-Approval Safety Data Management
Recall SOPs and Procedures
Verify recall procedures are current and tested.
- Written recall and market withdrawal SOP current and approved?
- Recall classification criteria (Class I, II, III) documented with decision framework?
- 24/7 emergency contact list for recall team maintained and current?
- Field Alert Report (FAR) SOP including 3-day reporting timeline?
- Press release, consignee notification, and FDA letter templates prepared?
Product Traceability and Distribution Records
Verify traceability and distribution record availability.
- Distribution records maintained enabling lot-level traceability to consignees?
- Current consignee database with contact information maintained?
- Distribution records accessible within 24 hours for any lot?
- DSCSA track-and-trace system implemented for prescription drug traceability?
- International distribution records available for exported products?
Mock Recall Exercises
Review mock recall performance.
- Annual mock recall exercise completed?
- Mock recall timed with trace-back to 100% lot accountability within required time?
- Mock recall tested realistic scenario including regulatory notification process?
- Mock recall lessons learned documented with improvements implemented?
- 3-calendar-day Field Alert Report timeline achievable per mock exercise?
FDA and Regulatory Notification
Verify notification procedures.
- FDA district office and recall coordination contacts current?
- Field Alert Report (FAR) requirements understood - 3-day initial, 15-day written?
- Recall strategy template (depth, public warning, effectiveness check) prepared?
- Legal review process for press releases and public communications established?
- International regulatory notification procedures for ex-US markets?
Recall Effectiveness Checks
Verify effectiveness check procedures.
- Recall effectiveness check SOP defining methodology and success criteria?
- Status report schedule for recall progress to FDA defined?
- Returned product tracking and reconciliation process defined?
- Recalled product destruction documentation and FDA notification process?
- Recall closure criteria and FDA closeout request process defined?
Documentation and Readiness
Verify recall documentation readiness.
- Recall readiness file organized with all required documentation?
- Product liability insurance current and covering recall costs?
- Regulatory legal counsel identified and engaged?
- Crisis communications plan for media and customer inquiries?
- Any prior recalls analyzed for systemic issues to prevent recurrence?
- Annual recall readiness assessment report prepared?
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Why Use This Pharmaceutical Product Recall Readiness Checklist?
This pharmaceutical product recall readiness checklist helps pharmaceutical & life sciences teams maintain compliance and operational excellence. Designed for regulatory affairs manager / quality director professionals, this checklist covers 31 critical inspection points across 6 sections. Recommended frequency: annual.
Ensures compliance with FDA 21 CFR Part 7 - Enforcement Policy (Recalls), FDA 21 CFR 314.81 - NDA Post-Marketing Reports (Field Alerts), EU Regulation No. 726/2004 - Post-Authorization Safety Measures, ICH E2D Post-Approval Safety Data Management. Regulatory-aligned for audit readiness and inspection documentation.
Frequently Asked Questions
What does the Pharmaceutical Product Recall Readiness Checklist cover?
This checklist covers 31 inspection items across 6 sections: Recall SOPs and Procedures, Product Traceability and Distribution Records, Mock Recall Exercises, FDA and Regulatory Notification, Recall Effectiveness Checks, Documentation and Readiness. It is designed for pharmaceutical & life sciences operations and compliance.
How often should this checklist be completed?
This checklist should be completed annual. Each completion takes approximately 30-45 minutes.
Who should use this Pharmaceutical Product Recall Readiness Checklist?
This checklist is designed for Regulatory Affairs 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.