Standard Operating Procedure for Ensuring Proper Use of Warehouse Storage Automation Systems
| Department | Warehouse / Quality Assurance / IT Support |
|---|---|
| SOP No. | SOP/RM/195/2025 |
| Supersedes | SOP/RM/195/2022 |
| Page No. | Page 1 of 15 |
| Issue Date | 30/04/2025 |
| Effective Date | 07/05/2025 |
| Review Date | 30/04/2026 |
1. Purpose
This Standard Operating Procedure (SOP) outlines the protocols for the proper use, maintenance, and monitoring of warehouse storage automation systems to ensure efficiency, accuracy, and compliance with Good Manufacturing Practices (GMP).
2. Scope
This SOP applies to all warehouse staff, IT personnel, and quality assurance teams involved in the operation, maintenance, and monitoring of automated storage systems within the warehouse.
3. Responsibilities
- Warehouse Manager: Oversee the implementation and proper use of storage automation systems.
- IT Support Team: Ensure the automation systems are operational, troubleshoot issues, and perform regular maintenance.
- Quality Assurance (QA) Team: Audit system compliance with operational and regulatory requirements.
4. Accountability
The Warehouse Manager is accountable for ensuring proper use of the automation systems. The IT Support Team is responsible for system maintenance and troubleshooting, while the QA Manager conducts regular audits to ensure compliance.
5. Procedure
5.1
System Setup and Initialization
- System Configuration:
- Ensure all automation systems are configured according to manufacturer specifications and GMP guidelines.
- Document configuration settings in the System Configuration Log (Annexure-1).
- User Access Setup:
- Assign system access levels based on job responsibilities and maintain a record of authorized users.
- Record user access in the User Access Log (Annexure-2).
5.2 Operation of Warehouse Automation Systems
- Material Storage and Retrieval:
- Ensure materials are stored and retrieved using automated systems to minimize manual handling and errors.
- Log storage and retrieval activities in the Storage & Retrieval Log (Annexure-3).
- System Monitoring:
- Regularly monitor the performance of automation systems to detect and address any anomalies.
- Document monitoring activities in the System Monitoring Log (Annexure-4).
5.3 Troubleshooting and Maintenance
- Issue Identification:
- Identify system malfunctions and log issues immediately in the Issue Identification Log (Annexure-5).
- System Maintenance:
- Perform routine system maintenance according to the manufacturer’s guidelines to ensure optimal performance.
- Record maintenance activities in the Maintenance Log (Annexure-6).
5.4 Data Integrity and Backup Procedures
- Data Entry Verification:
- Ensure all data entries in the automation system are accurate and verified by a second operator.
- Record verification activities in the Data Verification Log (Annexure-7).
- System Backup:
- Perform regular data backups to secure system data and prevent loss.
- Log backup activities in the Backup Log (Annexure-8).
5.5 Training and Compliance Audits
- System Training:
- Provide comprehensive training to all users on the proper use of warehouse automation systems.
- Document training sessions in the Training Log (Annexure-9).
- Compliance Audits:
- Conduct periodic audits to ensure adherence to SOP guidelines and regulatory compliance.
- Record audit findings in the Compliance Audit Log (Annexure-9).
6. Abbreviations
- SOP: Standard Operating Procedure
- QA: Quality Assurance
- GMP: Good Manufacturing Practice
- ERP: Enterprise Resource Planning
7. Documents
- System Configuration Log (Annexure-1)
- User Access Log (Annexure-2)
- Storage & Retrieval Log (Annexure-3)
- System Monitoring Log (Annexure-4)
- Issue Identification Log (Annexure-5)
- Maintenance Log (Annexure-6)
- Data Verification Log (Annexure-7)
- Backup Log (Annexure-8)
- Training Log (Annexure-9)
8. References
- 21 CFR Part 11 – Electronic Records; Electronic Signatures
- GAMP 5 – A Risk-Based Approach to Compliant GxP Computerized Systems
- FDA Guidance for Industry on Warehouse Management Systems
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
Annexure-1: System Configuration Log
| Date | System Name | Configuration Details | Configured By |
|---|---|---|---|
| 30/04/2025 | Automated Storage Unit A | Temperature set at 20°C, Humidity 45% | Ravi Kumar |
Annexure-2: User Access Log
| Date | Employee Name | Access Level | Authorized By |
|---|---|---|---|
| 30/04/2025 | Neha Verma | Admin | Warehouse Manager |
Annexure-3: Storage & Retrieval Log
| Date | Material Name | Action (Stored/Retrieved) | Performed By |
|---|---|---|---|
| 30/04/2025 | Paracetamol API | Stored | Amit Joshi |
Annexure-4: System Monitoring Log
| Date | System Name | Status | Checked By |
|---|---|---|---|
| 30/04/2025 | Automated Conveyor | Operational | Kiran Patel |
Annexure-5: Issue Identification Log
| Date | Issue Identified | Description | Reported By |
|---|---|---|---|
| 30/04/2025 | System Freeze | Storage unit unresponsive during retrieval | Ravi Kumar |
Annexure-6: Maintenance Log
| Date | System Name | Maintenance Performed | Performed By |
|---|---|---|---|
| 30/04/2025 | Automated Storage Unit A | System Reboot and Software Update | IT Support |
Annexure-7: Data Verification Log
| Date | Data Verified | Verification Method | Verified By |
|---|---|---|---|
| 30/04/2025 | Paracetamol API Batch #12345 | Double-Check Entry | QA Team |
Annexure-8: Backup Log
| Date | System Name | Backup Type | Performed By |
|---|---|---|---|
| 30/04/2025 | Warehouse Automation System | Full Backup | IT Support |
Annexure-9: Training Log
| Date | Employee Name | Training Topic | Trainer | Remarks |
|---|---|---|---|---|
| 30/04/2025 | Neha Verma | Warehouse Automation System Usage | IT Support | Completed Successfully |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial Version | New SOP Implementation | QA Head |
| 30/04/2025 | 2.0 | Included data integrity and backup procedures. | Regulatory Update | QA Head |