GMP Warehouse Audit Checklist

Use this GMP Warehouse Audit Checklist to verify compliance with Good Manufacturing Practices by inspecting receiving areas, storage conditions, and more.

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Warehouse
GMP Warehouse Audit Checklist

Receiving Area

Storage Conditions

Handling And Transportation

Documentation

Security And Access Control

Cleaning And Sanitation

Emergency Preparedness

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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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GMP Warehouse Audit Checklist

Use this GMP Warehouse Audit Checklist to verify compliance with Good Manufacturing Practices by inspecting receiving areas, storage conditions, and more.

1. Is the incoming materials inspection procedure documented and followed?

2. Is the supplier Certificate of Analysis (COA) verified against specifications?

3. Are packages inspected for damage or compromise?

4. Is proper labeling and identification of received materials ensured?

5. Are materials segregated based on required storage conditions (e.g., ambient, refrigerated, frozen)?

1. Is temperature and humidity monitoring equipment installed and functioning properly?

2. Is proper segregation of materials maintained to prevent cross-contamination?

3. Are storage conditions verified to be suitable for each product (ambient, refrigerated, frozen)?

4. Is a FIFO (First In, First Out) or FEFO (First Expired, First Out) system implemented and followed?

5. Is there adequate space between materials to facilitate cleaning and inspection?

1. Is appropriate equipment (e.g., forklifts, pallet jacks) used for handling materials?

2. Are materials handled by trained personnel to prevent damage?

3. Is equipment cleaned and sanitized regularly to prevent contamination?

4. Are records of transportation and handling activities maintained?

5. Are procedures for handling deviations or non-conforming materials implemented?

1. Are accurate records of receipt, storage, and distribution activities maintained?

2. Are deviations from standard procedures and corrective actions documented?

3. Are records retained for the required retention period?

4. Is documentation readily accessible for audits and inspections?

5. Are documentation procedures regularly reviewed for compliance and effectiveness?

1. Are access control measures implemented to prevent unauthorized entry?

2. Is access limited to authorized personnel only?

3. Are warehouse premises monitored through CCTV or other security measures?

4. Are storage areas for controlled substances or high-value materials secured?

5. Are regular security assessments and training conducted for warehouse staff?

1. Is there a developed and implemented cleaning schedule for warehouse areas?

2. Are approved cleaning agents and methods used for sanitation?

3. Do cleaning procedures cover all surfaces, including racks, floors, and equipment?

4. Is the effectiveness of cleaning verified through regular inspections and microbial testing?

5. Is appropriate PPE (Personal Protective Equipment) provided for cleaning personnel?

1. Is there a developed and maintained emergency response plan for incidents such as spills, fires, or natural disasters?

2. Are regular drills conducted to ensure staff familiarity with emergency procedures?

3. Is appropriate emergency response equipment, such as fire extinguishers and spill kits, provided?

4. Is emergency contact information readily available?

5. Is the emergency response plan reviewed and updated regularly based on lessons learned from drills or incidents?