Pharmaceutical Compound Record Review Checklist
Ensure every batch is perfect. Our Pharmaceutical Compound Record Review Checklist streamlines your process, minimizing errors & maximizing compliance. Download now & elevate your quality control.
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Raw Material Verification
Ensuring correct raw materials are used, including lot number and expiry date verification.
Raw Material Status
Raw Material Name
Lot Number
Expiry Date
Quantity Received
Quantity Used
Supplier Name
Received By (Signature)
Equipment Setup and Calibration
Confirmation of correct equipment setup, calibration status, and functionality.
Equipment ID
Calibration Due Date
Calibration Status
Calibration Reading (Before)
Calibration Reading (After)
Calibration Method
Calibrator Signature
Calibration Notes/Comments
Weighing and Measurement Accuracy
Verification of accurate weighing of raw materials and in-process components.
Raw Material Weight (Actual)
Raw Material Weight (Target)
Weight Variance (Actual vs. Target)
Within Tolerance?
Discrepancy Notes (if applicable)
Weighing Date
Weighing Time
Weigher Signature
Mixing and Processing Parameters
Review of mixing times, temperatures, speeds, and other critical process parameters.
Mixing Speed (RPM)
Mixing Time (Minutes)
Temperature (°C)
pH
Start Time
Date of Mixing
Mixing Mode (e.g., Continuous, Intermittent)
In-Process Controls (IPC)
Checking of all in-process controls and adherence to specifications.
pH Value
Temperature (°C)
Particle Size (µm)
Appearance
Reaction Completion Time
Viscosity Characteristics
Additional IPC Observations
Documentation Completeness
Ensuring all steps are documented legibly and completely in the compound record.
Description of any deviations from standard procedure
Operator's initials
Date of compounding
Start time of compounding
Reviewer Signature
Procedure Version Used
Number of revisions
Batch Number and Record Integrity
Verification of correct batch number assignment and overall record integrity.
Assigned Batch Number
Record Creation Date (System Generated)
Record Review Date
Reviewer Signature
Unique Record Identifier (if applicable)
Record Alteration Log (if any)
Record Status
Deviation Handling & Resolution
Documentation of any deviations from standard procedures and their resolutions.
Detailed Description of Deviation
Deviation Category (e.g., Equipment, Material, Process)
Estimated Impact on Product Quality (Scale of 1-5)
Date Deviation Occurred
Root Cause Analysis
Corrective Actions Taken
Date Corrective Actions Implemented
Signature of Person Implementing Corrective Action
Final Product Appearance & Testing
Assessment of final product appearance and pending/completed testing results.
Detailed Description of Final Product Appearance
Visual Defects Observed (select all that apply)
Particle Size (Microns)
Appearance Assessment - Pass/Fail
Testing Completion Date
Photo Documentation of Product Appearance (if applicable)
Record Review & Approval
Review and approval of the complete compound record by designated personnel.
Record Review Date
Reviewer Signature
Reviewer Name
Reviewer Employee ID
Record Status (Approved/Rejected)
Review Comments (if rejected)
Approval Signature (if approved)
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