Standard Operating Procedure for Managing Warehouse Security and Preventing Unauthorized Access
| Department | Warehouse / Quality Assurance / Security |
|---|---|
| SOP No. | SOP/RM/193/2025 |
| Supersedes | SOP/RM/193/2022 |
| Page No. | Page 1 of 15 |
| Issue Date | 28/04/2025 |
| Effective Date | 05/05/2025 |
| Review Date | 28/04/2026 |
1. Purpose
This Standard Operating Procedure (SOP) outlines the measures and protocols for managing warehouse security and preventing unauthorized access to ensure the safety and integrity of raw materials.
2. Scope
This SOP applies to all personnel, including warehouse staff, security personnel, and visitors, who have access to the warehouse premises where raw materials are stored.
3. Responsibilities
- Warehouse Manager: Ensure that all security protocols are implemented and adhered to by warehouse staff.
- Security Supervisor: Oversee security operations, manage access control systems, and monitor surveillance equipment.
- Quality Assurance (QA) Team: Conduct periodic audits to ensure compliance with security protocols.
4. Accountability
The Warehouse Manager is accountable for overall security management in the warehouse. The Security Supervisor is responsible for enforcing access control measures, and the QA Manager ensures compliance through regular audits.
5. Procedure
5.1 Access Control Measures
- Authorization for Access:
- Only authorized personnel with valid identification
are permitted to enter the warehouse.
Document authorization in the Access Authorization Log (Annexure-1).
Visitor Management:
- All visitors must sign in at the security desk and be escorted by authorized personnel.
- Record visitor details in the Visitor Log (Annexure-2).
5.2 Surveillance and Monitoring
- CCTV Surveillance:
- Ensure all entry points, sensitive storage areas, and loading docks are covered by CCTV cameras.
- Maintain surveillance footage records in the Surveillance Monitoring Log (Annexure-3).
- Alarm Systems:
- Install motion detectors and alarm systems to detect unauthorized access.
- Record alarm system tests and maintenance in the Alarm System Log (Annexure-4).
5.3 Handling Security Breaches
- Identifying Breaches:
- Any unauthorized access attempts must be immediately reported to the Security Supervisor.
- Document incidents in the Security Breach Log (Annexure-5).
- Response to Breaches:
- Initiate emergency protocols in case of a security breach, including lockdown procedures if necessary.
- Record corrective actions in the Corrective Action Log (Annexure-6).
5.4 Training and Compliance Audits
- Security Training:
- Provide security training for all warehouse staff, including emergency response and access control procedures.
- Record training sessions in the Training Log (Annexure-7).
- Compliance Audits:
- Conduct periodic audits to verify compliance with security protocols.
- Document audit results in the Compliance Audit Log (Annexure-8).
5.5 Maintenance of Security Systems
- System Checks:
- Regularly inspect and maintain security systems, including CCTV cameras, access control systems, and alarms.
- Document maintenance activities in the Security System Maintenance Log (Annexure-9).
6. Abbreviations
- SOP: Standard Operating Procedure
- QA: Quality Assurance
- CCTV: Closed-Circuit Television
7. Documents
- Access Authorization Log (Annexure-1)
- Visitor Log (Annexure-2)
- Surveillance Monitoring Log (Annexure-3)
- Alarm System Log (Annexure-4)
- Security Breach Log (Annexure-5)
- Corrective Action Log (Annexure-6)
- Training Log (Annexure-7)
- Compliance Audit Log (Annexure-8)
- Security System Maintenance Log (Annexure-9)
8. References
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
- OSHA Warehouse Safety Guidelines
- FDA Guidance for Securing Pharmaceutical Warehouses
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
Annexure-1: Access Authorization Log
| Date | Employee Name | Access Level | Authorized By |
|---|---|---|---|
| 28/04/2025 | Ravi Kumar | Full Access | Warehouse Manager |
Annexure-2: Visitor Log
| Date | Visitor Name | Purpose of Visit | Escorted By |
|---|---|---|---|
| 28/04/2025 | Neha Verma | Regulatory Inspection | Amit Joshi |
Annexure-3: Surveillance Monitoring Log
| Date | Camera Location | Status | Checked By |
|---|---|---|---|
| 28/04/2025 | Main Entrance | Operational | Kiran Patel |
Annexure-4: Alarm System Log
| Date | System Tested | Result | Tested By |
|---|---|---|---|
| 28/04/2025 | Motion Detector | Functional | Security Team |
Annexure-5: Security Breach Log
| Date | Breach Type | Description | Reported By |
|---|---|---|---|
| 28/04/2025 | Unauthorized Access Attempt | Attempted Entry via Loading Dock | Ravi Kumar |
Annexure-6: Corrective Action Log
| Date | Issue | Corrective Action Taken | Performed By |
|---|---|---|---|
| 28/04/2025 | Unauthorized Access | Strengthened Security Protocols | Security Supervisor |
Annexure-7: Training Log
| Date | Employee Name | Training Topic | Trainer | Remarks |
|---|---|---|---|---|
| 28/04/2025 | Amit Joshi | Warehouse Security Procedures | QA Manager | Completed Successfully |
Annexure-8: Compliance Audit Log
| Date | Audit Area | Findings | Auditor |
|---|---|---|---|
| 28/04/2025 | Access Control System | No Issues Found | QA Team |
Annexure-9: Security System Maintenance Log
| Date | System Name | Maintenance Activity | Performed By |
|---|---|---|---|
| 28/04/2025 | CCTV Cameras | System Check and Cleaning | Maintenance Team |
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 |
| 28/04/2025 | 2.0 | Updated with additional surveillance and breach handling procedures. | Regulatory Update | QA Head |