PHARMACEUTICAL COMPOUND RECORD REVIEW CHECKLIST

Created by ChecklistGuro (https://checklistguro.com)


--- RAW MATERIAL VERIFICATION ---
[ ] Raw Material Status (Approved, Quarantine, Rejected)
[ ] Raw Material Name
[ ] Lot Number
[ ] Expiry Date
[ ] Quantity Received
[ ] Quantity Used
[ ] Supplier Name (Supplier A, Supplier B, Supplier C)
[ ] Received By (Signature)

--- EQUIPMENT SETUP AND CALIBRATION ---
[ ] Equipment ID
[ ] Calibration Due Date
[ ] Calibration Status (Current, Overdue, Pending)
[ ] Calibration Reading (Before)
[ ] Calibration Reading (After)
[ ] Calibration Method
[ ] Calibrator Signature
[ ] Calibration Notes/Comments

--- WEIGHING AND MEASUREMENT ACCURACY ---
[ ] Raw Material Weight (Actual)
[ ] Raw Material Weight (Target)
[ ] Weight Variance (Actual vs. Target)
[ ] Within Tolerance? (Yes, No)
[ ] Discrepancy Notes (if applicable)
[ ] Weighing Date
[ ] Weighing Time
[ ] Weigher Signature

--- MIXING AND PROCESSING PARAMETERS ---
[ ] Mixing Speed (RPM)
[ ] Mixing Time (Minutes)
[ ] Temperature (°C)
[ ] pH
[ ] Start Time
[ ] Date of Mixing
[ ] Mixing Mode (e.g., Continuous, Intermittent) (Continuous, Intermittent)

--- IN-PROCESS CONTROLS (IPC) ---
[ ] pH Value
[ ] Temperature (°C)
[ ] Particle Size (µm)
[ ] Appearance (Clear, Cloudy, Milky, Particulate Matter)
[ ] Reaction Completion Time
[ ] Viscosity Characteristics (Low, Medium, High)
[ ] Additional IPC Observations

--- DOCUMENTATION COMPLETENESS ---
[ ] Description of any deviations from standard procedure
[ ] Operator's initials
[ ] Date of compounding
[ ] Start time of compounding
[ ] Reviewer Signature
[ ] Procedure Version Used (Version 5.0, Version 3.2, Version 2.1)
[ ] Number of revisions

--- BATCH NUMBER AND 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 (Active, Inactive, Archived)

--- DEVIATION HANDLING & RESOLUTION ---
[ ] Detailed Description of Deviation
[ ] Deviation Category (e.g., Equipment, Material, Process) (Equipment, Material, Process, Personnel, Other)
[ ] 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 ---
[ ] Detailed Description of Final Product Appearance
[ ] Visual Defects Observed (select all that apply) (Discoloration, Foreign Particles, Crystallization, Clumping, None Observed)
[ ] Particle Size (Microns)
[ ] Appearance Assessment - Pass/Fail (Pass, Fail)
[ ] Testing Completion Date
[ ] Photo Documentation of Product Appearance (if applicable)

--- RECORD REVIEW & APPROVAL ---
[ ] Record Review Date
[ ] Reviewer Signature
[ ] Reviewer Name
[ ] Reviewer Employee ID
[ ] Record Status (Approved/Rejected) (Approved, Rejected)
[ ] Review Comments (if rejected)
[ ] Approval Signature (if approved)

--- END OF TEMPLATE ---
Transform this text into a digital, automated, and trackable mobile app!
Visit: https://checklistguro.com/templates/pharmaceutical/pharmaceutical-compound-record-review-checklist
(Click "Install Template" to launch your digital inspection tool immediately)