Batch Record Review Checklist - FREE PDF
Review batch records for completeness and compliance before product release.
- Industry: Pharmaceutical
- Frequency: Each batch
- Estimated Time: 1-4 hours per batch
- Role: QA Reviewer
- Total Items: 30
- Compliance: FDA 21 CFR 211, ICH Q7, EU GMP Annex 11
Pre-Inspection Setup
Verify conditions before proceeding.
- Proper authorization obtained?
- Required documentation available?
- Safety precautions in place?
Inspection Items
Detailed inspection per FDA 21 CFR 211.
- Overall condition acceptable?
- Regulatory compliance verified?
- Safety features functional?
- Documentation current?
Deficiencies & Corrective Actions
Document findings and required actions.
- Inspection Result
- Deficiencies Description
- Corrective Actions Required
- Follow-up Date
- Inspector Signature
Initial Setup & Documentation
Complete initial documentation and preparation
- Inspector / Assessor Name
- Date
- Location / Area
- Inspection Type
- Previous findings reviewed?
Safety & Compliance Verification
Verify all safety requirements are met
- All safety protocols being followed?
- Emergency exits clear and accessible?
- First aid supplies available and stocked?
- All hazards identified and controlled?
- Required PPE being worn correctly?
Operational Standards Check
Verify operational standards and procedures are maintained
- Standard operating procedures being followed?
- All equipment in proper working condition?
- Maintenance schedule current?
- All staff training current and documented?
Quality Assessment
Evaluate quality standards and performance metrics
- Quality standards met for all items checked?
- Any deficiencies or non-conformances identified?
- Root cause analysis completed for issues?
- Continuous improvement opportunities identified?
Related Pharmaceutical Checklists
- Equipment Validation Protocol - FREE PDF
- Deviation Investigation Checklist - FREE PDF
- Pharmaceutical Gmp Batch Record Review Checklist
- Pharmaceutical Cleanroom Environmental Monitoring Checklist
Why Use This Batch Record Review Checklist?
This batch record review checklist helps pharmaceutical teams maintain compliance and operational excellence. Designed for qa reviewer professionals, this checklist covers 30 critical inspection points across 7 sections. Recommended frequency: each batch.
Ensures compliance with FDA 21 CFR 211, ICH Q7, EU GMP Annex 11. Regulatory-aligned for audit readiness and inspection documentation.
Frequently Asked Questions
What does the Batch Record Review Checklist cover?
This checklist covers 30 inspection items across 7 sections: Pre-Inspection Setup, Inspection Items, Deficiencies & Corrective Actions, Initial Setup & Documentation, Safety & Compliance Verification, Operational Standards Check, Quality Assessment. It is designed for pharmaceutical operations and compliance.
How often should this checklist be completed?
This checklist should be completed each batch. Each completion takes approximately 1-4 hours per batch.
Who should use this Batch Record Review Checklist?
This checklist is designed for QA Reviewer 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.