Pharmaceutical Product Recall Readiness Checklist
Pharmaceutical recall readiness is a regulatory requirement and patient safety obligation. This readiness checklist verifies that distribution traceability, notification procedures, and effectiveness check programs meet FDA 21 CFR 7 recall requirements.
- Industry: Pharmaceutical & Life Sciences
- Frequency: Annual Readiness Review / Per Recall Event
- Estimated Time: 30-45 minutes
- Role: QA Director / Regulatory Affairs Director
- Total Items: 31
- Compliance: FDA 21 CFR Part 7 - Enforcement Policy: Recalls, FDA Regulatory Procedures Manual Chapter 7 - Recall Procedures, FDA Guidance for Industry - Product Recalls Including Removals and Corrections, EU GMP Chapter 8.5 - Product Recalls
Distribution Records and Traceability
Verify distribution traceability capability.
- Complete lot-level distribution records accessible for all marketed lots?
- Customer database current with current contact information for all accounts?
- Ability to generate consignee list by lot number within 2 hours?
- Quantity shipped by lot trackable from distribution records?
- Downstream tracing capability to retail or patient level where required?
Health Hazard Evaluation
Verify HHE capability.
- Medical officer or qualified clinician available to lead HHE?
- HHE template and procedure in place for rapid health hazard assessment?
- Recall class determination procedure documented per FDA Class I/II/III criteria?
- Risk assessment methodology for determining recall depth documented?
- Access to medical, toxicological, and regulatory expertise for HHE support?
FDA Notification and Communication
Verify FDA notification procedures.
- FDA District Office contact and reporting procedures documented?
- Field Alert Report (FAR) procedure for 3-day initial notification ready?
- Recall strategy template prepared per 21 CFR 7.42?
- Press release template prepared for Class I/II public recalls?
- Media spokesperson and communications protocol designated?
Customer and Downstream Notification
Verify customer notification capability.
- Recall notification letter template prepared per FDA format requirements?
- Ability to notify all direct accounts within 24 hours for Class I?
- Return/destruction instructions and authorization numbers process documented?
- Process for directing customers to notify their own downstream customers?
- Recall hotline or contact point established for customer inquiries?
Effectiveness Checks
Verify effectiveness check procedures.
- Effectiveness check procedure documented per FDA recall check requirements?
- Effectiveness check depth (Level A-D) selection criteria documented?
- Process for following up with non-responding accounts documented?
- Recall status reporting schedule to FDA (typically every 2 weeks) documented?
- Recall termination criteria and FDA termination letter process documented?
Mock Recall and Training
Verify recall preparedness training.
- Annual mock recall exercise conducted within past year?
- Mock recall completing distribution traceability within 2-hour target?
- Recall team members trained on recall procedures?
- Recall team member list current with alternates for all key roles?
- Lessons from mock recalls or actual recalls incorporated into procedures?
- Annual recall readiness report completed?
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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 qa director / regulatory affairs director professionals, this checklist covers 31 critical inspection points across 6 sections. Recommended frequency: annual readiness review / per recall event.
Ensures compliance with FDA 21 CFR Part 7 - Enforcement Policy: Recalls, FDA Regulatory Procedures Manual Chapter 7 - Recall Procedures, FDA Guidance for Industry - Product Recalls Including Removals and Corrections, EU GMP Chapter 8.5 - Product Recalls. 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: Distribution Records and Traceability, Health Hazard Evaluation, FDA Notification and Communication, Customer and Downstream Notification, Effectiveness Checks, Mock Recall and Training. It is designed for pharmaceutical & life sciences operations and compliance.
How often should this checklist be completed?
This checklist should be completed annual readiness review / per recall event. Each completion takes approximately 30-45 minutes.
Who should use this Pharmaceutical Product Recall Readiness Checklist?
This checklist is designed for QA Director / Regulatory Affairs 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.