Warehouse Audit Checklist in Pharmaceutical Industry

Use this Warehouse Audit Checklist for pharmaceutical or medical industry warehouses to assess storage conditions, inventory accuracy, order planning, etc.

Warehouse Audit Checklist in Pharmaceutical Industry



Storage Conditions And Environmental Control

1. Are temperature and humidity levels continuously monitored and recorded?


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2. Are storage areas maintained within the specified conditions for pharmaceutical products?


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3. Are alarm systems in place to detect deviations in temperature or humidity?


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4. Is there evidence of calibration for temperature and humidity monitoring devices?


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5. Are corrective actions documented when storage conditions fall outside acceptable limits?


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Facility Cleanliness And Hygiene

1. Are floors, walls, and ceilings clean and free from contamination?


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2. Are cleaning schedules and logs maintained for all warehouse zones?


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3. Are pest control measures documented and regularly reviewed?


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4. Are waste disposal practices in line with pharmaceutical regulations?


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5. Are cleaning agents suitable and approved for pharmaceutical environments?


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Material Identification And Segregation

1. Are all products clearly labeled with name, batch number, and status (e.g., quarantined, approved)?


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2. Are quarantined, rejected, and returned goods stored separately?


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3. Are materials segregated to prevent mix-ups and cross-contamination?


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4. Is there a system in place to control and trace the movement of materials?


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5. Are high-risk materials stored with appropriate security measures?


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Inventory Management And Traceability

1. Are inventory records accurate and up to date?


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2. Is there a FIFO or FEFO (First Expiry First Out) system in place?


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3. Are stock discrepancies investigated and documented?


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4. Are materials traceable by batch throughout their lifecycle?


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5. Are regular cycle counts or physical inventories performed?


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Equipment And Handling Procedures

1. Is the handling equipment clean, calibrated, and well-maintained?


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2. Are materials transported under controlled conditions when required?


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3. Are pallets, racks, and containers suitable for pharmaceutical storage?


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4. Are loading/unloading areas protected from weather and contamination?


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5. Are employees trained in handling practices specific to pharmaceutical goods?


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Documentation And Compliance

1. Are SOPs available and followed for all warehouse operations?


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2. Are all warehouse activities documented with proper GMP records?


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3. Are deviations or non-conformities recorded and reviewed?


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4. Are records archived securely and retrievable upon inspection?


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5. Are there up-to-date training records for all warehouse staff?


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Security And Access Control

1. Is access to the warehouse restricted to authorized personnel only?


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2. Are there security systems, such as surveillance and access logs, in place?


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3. Are controlled drugs stored in accordance with regulatory requirements?


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4. Are delivery and dispatch procedures documented and secure?


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5. Are incidents or breaches of security reported and investigated?


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Checklist by GoAudits.com – Please note that this checklist is intended as an example. We do not guarantee compliance with the laws applicable to your territory or industry. You should seek professional advice to determine how this checklist should be adapted to your workplace or jurisdiction.

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