FDA GMP Inspection Readiness Audit Checklist
FDA GMP inspections require systematic advance preparation. This readiness audit reviews all high-risk GMP systems likely to be inspected and prepares personnel and documentation for PAI, surveillance, or for-cause inspections.
- Industry: Pharmaceutical & Life Sciences
- Frequency: Annual / Pre-Inspection
- Estimated Time: 90-120 minutes
- Role: QA Director / Regulatory Affairs Director
- Total Items: 31
- Compliance: FDA 21 CFR Parts 210/211 cGMP for Finished Pharmaceuticals, FDA Systems-Based Inspection Approach (Quality System Model), FDA Pre-Approval Inspection (PAI) Guidance, EMA GMP Inspection Program
Quality System
Review quality system readiness.
- No overdue CAPAs from previous inspections or audits?
- CAPA metrics showing improving trends?
- Annual Product Quality Review (APQR) complete for all products?
- Self-inspection program current with no critical open findings?
- Quality Manual and site SOP hierarchy current and accessible?
Laboratory Controls
Review laboratory GMP readiness.
- No critical instruments with overdue calibration?
- All OOS investigations complete with no unresolved results?
- Data integrity review completed with no open vulnerabilities?
- All compendial and in-house methods validated with current reports?
- 5 years of laboratory records accessible and retrievable?
Production and Process Controls
Review production GMP readiness.
- No unresolved production deviations or investigations?
- Batch records for last 5 years accessible and complete?
- Process validation current for all marketed products?
- Cleaning validation current for all shared equipment?
- All manufacturing areas in clean, GMP-compliant condition?
Personnel and Training Readiness
Prepare personnel for FDA inspection.
- Subject matter experts identified for each GMP system?
- Key personnel trained on how to respond to FDA investigator questions?
- Escort plan established for facility walkthrough?
- All personnel training records current with no gaps?
- Senior management committed to prioritizing inspection over production schedule?
Facility and Equipment Readiness
Ensure facility is in inspection-ready condition.
- All manufacturing and laboratory areas in GMP-compliant condition?
- All equipment with current status labels?
- No loose, unsecured, or unofficial documents in production areas?
- Pest control program current with no active issues?
- All critical utilities (water, HVAC, compressed air) operating within specs?
Document Retrieval and War Room
Prepare document retrieval and inspection management.
- Document inventory prepared for likely inspection requests?
- Back room (document review team) plan established?
- Prior 483 responses and Warning Letter commitments status documented?
- Legal counsel identified and available if needed?
- Escalation process for unexpected inspection issues defined?
- Complete readiness audit report prepared with gap remediation plan?
Related Pharmaceutical Life Sciences Checklists
- Annual Product Quality Review (APQR) Preparation Checklist
- Pharmaceutical Product Complaint Handling Checklist
- Pharmaceutical Product Recall Readiness Checklist
- GxP Training Compliance and Competency Audit Checklist
- Pharmaceutical Cleanroom Environmental Monitoring Checklist
- Pharmaceutical Daily Manufacturing Area Inspection Checklist
- Sterile Manufacturing Area Audit Checklist
- Batch Production Record Review Checklist
Related Regulatory Readiness Checklists
- GxP Training Compliance and Competency Audit Checklist - FREE Download
- FDA Inspection Readiness Assessment Checklist - FREE Download
- Pharmaceutical Product Recall Readiness Checklist - FREE Download
- Annual Product Quality Review (APQR) Preparation Checklist - FREE Download
- Pharmaceutical Product Complaint Handling Checklist - FREE Download
- Pharmaceutical Product Recall Readiness Checklist - FREE Download
Why Use This FDA GMP Inspection Readiness Audit Checklist?
This fda gmp inspection readiness audit 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 / pre-inspection.
Ensures compliance with FDA 21 CFR Parts 210/211 cGMP for Finished Pharmaceuticals, FDA Systems-Based Inspection Approach (Quality System Model), FDA Pre-Approval Inspection (PAI) Guidance, EMA GMP Inspection Program. Regulatory-aligned for audit readiness and inspection documentation.
Frequently Asked Questions
What does the FDA GMP Inspection Readiness Audit Checklist cover?
This checklist covers 31 inspection items across 6 sections: Quality System, Laboratory Controls, Production and Process Controls, Personnel and Training Readiness, Facility and Equipment Readiness, Document Retrieval and War Room. It is designed for pharmaceutical & life sciences operations and compliance.
How often should this checklist be completed?
This checklist should be completed annual / pre-inspection. Each completion takes approximately 90-120 minutes.
Who should use this FDA GMP Inspection Readiness Audit 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.