Checklist for Audit in Warehouse
📦 Checklist for Audit in Warehouse (Pharmaceuticals)
1. General Warehouse Conditions
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✅ Clean, well-organized, and free from dust, pests, and waste.
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✅ Adequate space for material movement and segregation.
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✅ Environmental monitoring records available (temperature, humidity, pressure).
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✅ Pest control records maintained and up to date.
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✅ Proper lighting and ventilation.
2. Material Receipt & Quarantine
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✅ Raw materials received against approved suppliers and purchase orders.
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✅ Materials labeled with status (Quarantine/Released/Rejected).
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✅ Visual inspection records available (damage, leakage, contamination).
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✅ Materials segregated physically or by system controls.
3. Storage Practices
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✅ Storage as per manufacturer’s recommendations (temperature, RH).
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✅ Controlled access to narcotics, APIs, and hazardous materials.
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✅ FEFO/FIFO system implemented.
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✅ Expired or rejected materials segregated in a controlled area.
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✅ Pallets, racks, and bins maintained in clean condition.
4. Temperature & Environmental Control
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✅ Calibrated temperature & humidity monitoring devices installed.
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✅ Alarm system in place for excursions.
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✅ Qualification records of warehouse (DQ/IQ/OQ/PQ).
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✅ Mapping studies performed for controlled storage areas (cold room, freezers).
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✅ Periodic review of monitoring data and deviation records.
5. Documentation & Records
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✅ SOPs available for receiving, storage, dispensing, and distribution.
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✅ Logbooks filled correctly and contemporaneously.
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✅ Material movement tracked (ERP/SAP/manual).
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✅ Calibration and preventive maintenance records for warehouse equipment (balances, forklifts, HVAC).
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✅ Training records of warehouse staff updated.
6. Dispensing & Sampling
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✅ Dedicated dispensing and sampling booths with dust extraction.
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✅ Cross-contamination prevention measures in place.
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✅ Proper gowning followed during dispensing.
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✅ Labels verified before dispensing.
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✅ Weighing balances calibrated and verified.
7. Finished Goods Storage & Distribution
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✅ Released goods clearly identified and segregated from quarantine/rejected stock.
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✅ Distribution records traceable to batch numbers and customers.
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✅ Transportation conditions validated (cold chain monitoring).
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✅ Returned goods handled as per SOP and investigated.
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✅ Recall procedure established and tested periodically.
8. Housekeeping & Safety
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✅ Safety signs and fire extinguishers available and accessible.
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✅ Hazardous materials stored with secondary containment.
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✅ Proper PPE usage in warehouse areas.
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✅ No obstruction in pathways, fire exits, or emergency routes.
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