PHARMACEUTICAL BATCH RECORD REVIEW CHECKLIST

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--- BATCH HEADER VERIFICATION ---
[ ] Batch Number
[ ] Manufacturing Date
[ ] Expiry Date
[ ] Batch Size (Units)
[ ] Manufacturing Site (Site A, Site B, Site C)
[ ] Batch Record Notes (if applicable)

--- RAW MATERIAL TRACEABILITY ---
[ ] Raw Material Name
[ ] Lot Number
[ ] Receipt Date
[ ] Supplier (Supplier A, Supplier B, Supplier C)
[ ] Certificate of Analysis (CoA)
[ ] Supplier Reference Number
[ ] Quantity Received

--- EQUIPMENT LOG REVIEW ---
[ ] Equipment ID
[ ] Calibration Date
[ ] Calibration Result
[ ] Calibration Status (Pass, Fail, NA)
[ ] Calibration Notes
[ ] Last Maintenance Date
[ ] Technician Signature

--- IN-PROCESS CONTROL (IPC) DATA VALIDATION ---
[ ] Temperature (deg C)
[ ] pH Value
[ ] Viscosity (cP)
[ ] Appearance (Clear, Turbid, Milky, Other)
[ ] Appearance Notes (if applicable)
[ ] IPC Test Date
[ ] IPC Tester Signature

--- MANUFACTURING PROCESS ADHERENCE ---
[ ] Step Number Verified
[ ] Step Procedure Followed? (Yes, No, N/A)
[ ] Detailed Observations/Comments on Process Adherence
[ ] Date of Procedure Execution
[ ] Time of Procedure Execution
[ ] Critical Process Parameters Monitored (Temperature, Pressure, pH, Humidity, Agitation Speed)
[ ] Operator Signature

--- DEVIATION & CHANGE CONTROL REVIEW ---
[ ] Deviation Report Number
[ ] Deviation Occurrence Date
[ ] Summary of Deviation
[ ] Root Cause Identified? (Yes, No)
[ ] Root Cause Investigation Details
[ ] Corrective Action Plan Approved? (Yes, No)
[ ] Corrective Action Plan Description
[ ] Corrective Action Completion Date

--- QUALITY CONTROL (QC) TESTING VERIFICATION ---
[ ] Sample Size (n)
[ ] Result - Assay
[ ] Result - Impurity 1
[ ] Result - Impurity 2
[ ] Pass/Fail Status (Pass, Fail, Pending)
[ ] Failure Investigation (if applicable)
[ ] QC Release Date
[ ] QC Analyst Signature

--- DOCUMENTATION COMPLETENESS & ACCURACY ---
[ ] Reviewer Signature
[ ] Review Date
[ ] Comments/Observations (if any)
[ ] Document Legibility (Excellent, Good, Fair, Poor)
[ ] Number of Pages Reviewed
[ ] Required Signatures Present (Manufacturing Lead, Quality Assurance, Packaging Lead)

--- BATCH RELEASE APPROVAL ---
[ ] Quality Assurance Reviewer Signature
[ ] Review Date
[ ] Batch Number (Confirmation)
[ ] Release Status (Approved, Rejected, Conditional Approval)
[ ] Release Notes/Comments (if applicable)
[ ] Release Authorizer Signature

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