Pharmaceutical Deviation Management Checklist
This comprehensive pharmaceutical GMP checklist supports regulatory compliance with FDA 21 CFR Part 210, FDA 21 CFR Part 211, ICH Q7. Use it to document inspections, verify controls, and address nonconformities before audits or incidents.
- Industry: Pharmaceutical
- Frequency: Weekly
- Estimated Time: 30-45 minutes
- Role: QA Manager / GMP Compliance Officer
- Total Items: 35
- Compliance: FDA 21 CFR Part 210, FDA 21 CFR Part 211, ICH Q7, EU GMP (where applicable)
Documentation & Permits
Confirm required permits, procedures, and records are current and accessible.
- All required procedures and checklists available and in use?
- Controls and equipment in safe working order?
- Notes / observations
- Photo evidence (optional)
- Corrective action required?
Controls & Equipment
Verify critical equipment, safeguards, and monitoring devices are operational.
- All required procedures and checklists available and in use?
- Critical temperature reading
- Notes / observations
- Photo evidence (optional)
- Corrective action required?
Hazard Identification & Exposure Controls
Check that hazards are identified and exposure controls are implemented.
- All required procedures and checklists available and in use?
- Controls and equipment in safe working order?
- Notes / observations
- Photo evidence (optional)
- Corrective action required?
Training & Competency
Confirm required training, competency, and authorizations for the work scope.
- All required procedures and checklists available and in use?
- Controls and equipment in safe working order?
- Notes / observations
- Photo evidence (optional)
- Corrective action required?
Housekeeping & Storage
Verify housekeeping, labeling, segregation, and storage practices reduce risk.
- All required procedures and checklists available and in use?
- Controls and equipment in safe working order?
- Notes / observations
- Photo evidence (optional)
- Corrective action required?
Emergency Preparedness
Confirm emergency equipment, communications, and response procedures are ready.
- All required procedures and checklists available and in use?
- Controls and equipment in safe working order?
- Notes / observations
- Photo evidence (optional)
- Corrective action required?
Corrective Actions & Evidence
Document issues, assign actions, and capture evidence for closure.
- All required procedures and checklists available and in use?
- Controls and equipment in safe working order?
- Notes / observations
- Photo evidence (optional)
- Corrective action required?
Related Pharmaceutical Checklists
- Pharmaceutical Change Control Checklist
- Pharmaceutical Capas Management Checklist
- Pharmaceutical Supplier Qualification Checklist
- Pharmaceutical Raw Material Receiving Testing Checklist
- Pharmaceutical Labeling Packaging Control Checklist
- Pharmaceutical Temperature Mapping Storage Checklist
- Pharmaceutical Cold Chain Receiving Checklist
- Pharmaceutical Water System Sampling Checklist
Related Pharmacy Operations Checklists
- Pharmaceutical Gmp Batch Record Review Checklist - FREE Download
- Pharmaceutical Cleanroom Environmental Monitoring Checklist - FREE Download
- Pharmaceutical Aseptic Processing Checklist - FREE Download
- Pharmaceutical Equipment Cleaning Validation Checklist - FREE Download
- Pharmaceutical Process Validation Checklist - FREE Download
- Pharmaceutical Change Control Checklist - FREE Download
- Pharmaceutical Capas Management Checklist - FREE Download
- Pharmaceutical Supplier Qualification Checklist - FREE Download
- Pharmaceutical Raw Material Receiving Testing Checklist - FREE Download
- Pharmaceutical Labeling Packaging Control Checklist - FREE Download
Why Use This Pharmaceutical Deviation Management Checklist?
This pharmaceutical deviation management checklist helps pharmaceutical teams maintain compliance and operational excellence. Designed for qa manager / gmp compliance officer professionals, this checklist covers 35 critical inspection points across 7 sections. Recommended frequency: weekly.
Ensures compliance with FDA 21 CFR Part 210, FDA 21 CFR Part 211, ICH Q7, EU GMP (where applicable). Regulatory-aligned for audit readiness and inspection documentation.
Frequently Asked Questions
What does the Pharmaceutical Deviation Management Checklist cover?
This checklist covers 35 inspection items across 7 sections: Documentation & Permits, Controls & Equipment, Hazard Identification & Exposure Controls, Training & Competency, Housekeeping & Storage, Emergency Preparedness, Corrective Actions & Evidence. It is designed for pharmaceutical operations and compliance.
How often should this checklist be completed?
This checklist should be completed weekly. Each completion takes approximately 30-45 minutes.
Who should use this Pharmaceutical Deviation Management Checklist?
This checklist is designed for QA Manager / GMP Compliance Officer professionals in the pharmaceutical 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.