FDA 21 CFR 211.137 Expiration Dating Requirements Audit Checklist
This checklist covers FDA 21 CFR 211.137 Expiration Dating Requirements Audit Checklist requirements under applicable federal and industry regulations. Violations may result in civil penalties up to $15,625 per violation per day and potential operational suspension.
- Industry: Manufacturing
- Frequency: Quarterly
- Estimated Time: 20-30 minutes
- Role: Quality Manager
- Total Items: 20
- Compliance: 21 CFR Part 211, ICH Q10, FDA cGMP Guidelines
Regulatory Documentation & Compliance Status
Verify current regulatory compliance status and required documentation is in order.
- Are all batch production and control records complete and accurate?
- Has the Quality Control Unit reviewed and approved all deviations?
- Are equipment cleaning records current and complete for all product-contact equipment?
- Attach photo of equipment cleaning log and labels:
Safety Equipment & Inspection Records
Verify safety equipment condition and inspection record currency.
- Are all required safety inspections current and documented?
- Is personal protective equipment available, maintained, and used correctly?
- Number of open deficiencies from previous inspection:
- Attach photo of safety equipment and inspection records:
Work Practices & Housekeeping
Evaluate worker compliance with safe work practices and housekeeping standards.
- Are workers following established safe work procedures and using required PPE?
- Is housekeeping adequate with no trip hazards, blocked egress, or unsecured materials?
- Work area safety and housekeeping assessment:
- Attach photo of work area conditions and housekeeping:
Laboratory Records & CAPA
Verify laboratory record completeness and CAPA system effectiveness.
- Are laboratory records complete with all required data, instrument calibration, and analyst signatures?
- Is the CAPA system effectively identifying and resolving quality system issues?
- Number of open OOS investigations:
- QC Director or Quality Manager release certification:
Corrective Actions & Inspector Sign-Off
Document all deficiencies and assign corrective actions. POPProbe auto-assigns these to team members, generates a signed PDF report instantly, and tracks compliance status across all locations. -> Start free, no credit card required
- List all deficiencies identified in this inspection:
- Overall compliance status?
- Corrective actions assigned to (name and department):
- Inspector digital signature and date:
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Why Use This FDA 21 CFR 211.137 Expiration Dating Requirements Audit Checklist?
This fda 21 cfr 211.137 expiration dating requirements audit checklist helps manufacturing teams maintain compliance and operational excellence. Designed for quality manager professionals, this checklist covers 20 critical inspection points across 5 sections. Recommended frequency: quarterly.
Ensures compliance with 21 CFR Part 211, ICH Q10, FDA cGMP Guidelines. Regulatory-aligned for audit readiness and inspection documentation.
Frequently Asked Questions
What does the FDA 21 CFR 211.137 Expiration Dating Requirements Audit Checklist cover?
This checklist covers 20 inspection items across 5 sections: Regulatory Documentation & Compliance Status, Safety Equipment & Inspection Records, Work Practices & Housekeeping, Laboratory Records & CAPA, Corrective Actions & Inspector Sign-Off. It is designed for manufacturing operations and compliance.
How often should this checklist be completed?
This checklist should be completed quarterly. Each completion takes approximately 20-30 minutes.
Who should use this FDA 21 CFR 211.137 Expiration Dating Requirements Audit Checklist?
This checklist is designed for Quality Manager professionals in the manufacturing 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.