GMP Audit Check List- Filling and Packaging
1. Area & Environment
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Filling/packaging areas designed to prevent mix-ups and contamination.
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Environmental conditions (temperature, humidity, differential pressure) monitored.
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Cleanliness of the area maintained before, during, and after operation.
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Adequate lighting and ventilation available.
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Access restricted to authorized personnel only.
2. Line Clearance
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Line clearance performed and documented before starting each batch.
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No remnants of previous product, labels, or materials present.
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Workstations and equipment verified as clean and ready for use.
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Documentation reviewed and approved before start-up.
3. Equipment
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Equipment (filling machines, cappers, labelers, blisters, cartoners) qualified and calibrated.
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Cleaning and maintenance records up to date.
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Equipment labeled with status tags (Cleaned / In Use / To be Cleaned).
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Preventive maintenance program in place and records available.
4. Materials
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Approved bulk product issued as per BMR/BPR.
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Packaging components (labels, cartons, foils, bottles, blisters) verified against approved specifications.
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Reconciliation performed for packaging materials.
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Components stored in controlled conditions to prevent damage/contamination.
5. Filling Process
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Filling performed as per approved batch record/SOP.
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In-process checks (fill weight/volume, torque, integrity testing) conducted and recorded.
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Containers properly sealed, capped, or closed.
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Online rejection system functioning for defective units.
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Cross-contamination controls in place (e.g., dust extraction, laminar flow for sterile).
6. Packaging Process
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Correct labels and cartons used (verified by line clearance & reconciliation).
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Online coding and printing machines calibrated and verified.
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In-process checks performed (label accuracy, print clarity, barcodes, serialization if applicable).
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Rejected/defective units collected and destroyed as per SOP.
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Packaging line balanced with reconciliation at the end of batch.
7. Documentation
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Batch packaging record (BPR) maintained with complete entries.
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Real-time recording of activities (no backdating).
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Deviations or discrepancies documented and investigated.
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Final yield reconciled against theoretical yield.
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Records signed by both operator and checker (two-person verification).
8. Personnel & Training
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Personnel trained in GMP, hygiene, and specific filling/packaging operations.
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Proper gowning and PPE used by all staff.
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Access restricted to trained/authorized persons only.
9. Safety
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Machine guards and emergency stop switches functional.
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Handling of sharp objects (cutters, blades) done safely.
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Material Safety Data Sheets (MSDS) available for packaging inks, solvents, adhesives.
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Fire extinguishers and safety equipment available and accessible.
✅ Key Audit Focus Points:
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Cross-contamination prevention during filling/packaging.
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Reconciliation of labels and printed components.
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Verification of coding/serialization to prevent mislabeling.
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Compliance with ALCOA+ in documentation.
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