Pharmaceutical Batch Record Review Checklist
Ensure batch record accuracy and compliance! Our Pharmaceutical Batch Record Review Checklist streamlines your process, minimizes errors, and guarantees adherence to GMP guidelines. Download now and strengthen your quality control.
This Template was installed 2 times.
Batch Header Verification
Confirm accuracy and completeness of batch header information (batch number, manufacturing date, expiry date, etc.).
Batch Number
Manufacturing Date
Expiry Date
Batch Size (Units)
Manufacturing Site
Batch Record Notes (if applicable)
Raw Material Traceability
Verify raw material lot numbers, supplier details, and certificate of analysis (CoA) alignment.
Raw Material Name
Lot Number
Receipt Date
Supplier
Certificate of Analysis (CoA)
Supplier Reference Number
Quantity Received
Equipment Log Review
Assess equipment usage, cleaning records, and calibration status for each step.
Equipment ID
Calibration Date
Calibration Result
Calibration Status
Calibration Notes
Last Maintenance Date
Technician Signature
In-Process Control (IPC) Data Validation
Confirm IPC results are within specifications and documented correctly.
Temperature (deg C)
pH Value
Viscosity (cP)
Appearance
Appearance Notes (if applicable)
IPC Test Date
IPC Tester Signature
Manufacturing Process Adherence
Validate adherence to established manufacturing procedures and instructions.
Step Number Verified
Step Procedure Followed?
Detailed Observations/Comments on Process Adherence
Date of Procedure Execution
Time of Procedure Execution
Critical Process Parameters Monitored
Operator Signature
Deviation & Change Control Review
Check for any deviations from the approved process and associated change controls.
Deviation Report Number
Deviation Occurrence Date
Summary of Deviation
Root Cause Identified?
Root Cause Investigation Details
Corrective Action Plan Approved?
Corrective Action Plan Description
Corrective Action Completion Date
Quality Control (QC) Testing Verification
Confirm QC testing has been performed and results are within specifications.
Sample Size (n)
Result - Assay
Result - Impurity 1
Result - Impurity 2
Pass/Fail Status
Failure Investigation (if applicable)
QC Release Date
QC Analyst Signature
Documentation Completeness & Accuracy
Ensure all process steps, observations, and signatures are documented completely and accurately.
Reviewer Signature
Review Date
Comments/Observations (if any)
Document Legibility
Number of Pages Reviewed
Required Signatures Present
Batch Release Approval
Verify proper review and authorization for batch release based on completed record.
Quality Assurance Reviewer Signature
Review Date
Batch Number (Confirmation)
Release Status
Release Notes/Comments (if applicable)
Release Authorizer Signature
Pharmaceutical Management Solution Screen Recording
See how ChecklistGuro streamlines pharmaceutical management! This quick screen recording showcases how our BPM platform helps you track medications, manage inventory, and ensure compliance - all in one place. Learn how to save time and reduce errors. #pharmaceutical #pharmacy #bpm #checklistguro #medicationmanagement #compliance
Related Checklist Templates
Pharmaceutical Out-of-Specification (OOS) Investigation Checklist
Pharmaceutical Container Closure Integrity Testing Checklist
Pharmaceutical Cleaning Deviation Investigation Checklist
Pharmaceutical Annual Product Review (APR) Checklist
Pharmaceutical CAPA Management Checklist
Pharmaceutical Deviation Trend Analysis Checklist
Pharmaceutical Continuous Improvement Checklist
Pharmaceutical Overage Evaluation Checklist
Pharmaceutical Transport Validation Checklist
Pharmaceutical Process Validation Checklist Template
We can do it Together
Need help with Checklists?
Have a question? We're here to help. Please submit your inquiry, and we'll respond promptly.