Standard Operating Procedure for Warehouse Entry and Access Control for Raw Material Storage
| Department | Warehouse / Quality Assurance |
|---|---|
| SOP No. | SOP/RM/127/2025 |
| Supersedes | SOP/RM/127/2022 |
| Page No. | Page 1 of 15 |
| Issue Date | 24/02/2025 |
| Effective Date | 28/02/2025 |
| Review Date | 24/02/2026 |
1. Purpose
This Standard Operating Procedure (SOP) outlines the guidelines for controlling entry and access to the raw material warehouse to ensure the security, safety, and integrity of materials, while maintaining compliance with Good Manufacturing Practices (GMP).
2. Scope
This SOP applies to all personnel, including warehouse staff, quality assurance (QA) personnel, maintenance staff, and visitors who require access to the raw material storage areas.
3. Responsibilities
- Warehouse Personnel: Comply with access control procedures and report unauthorized access immediately.
- Warehouse Manager: Oversee and enforce warehouse entry protocols, maintain access records, and ensure security measures are followed.
- Security Personnel: Monitor entry points, verify access permissions, and maintain visitor logs.
- Quality Assurance (QA): Conduct periodic audits of access control records and ensure compliance with GMP requirements.
4. Accountability
The Warehouse Manager is accountable for implementing and maintaining access control procedures, while the QA Manager is responsible for verifying adherence to security protocols and
regulatory compliance.
5. Procedure
5.1 Access Authorization
- Personnel Access:
- Only authorized personnel with valid identification badges are permitted entry into the raw material storage areas.
- Access permissions must be approved by the Warehouse Manager and documented in the Authorized Personnel Register (Annexure-1).
- Visitor Access:
- Visitors, including contractors and regulatory inspectors, must be escorted by authorized personnel at all times.
- Visitors must sign in at the security desk and wear visitor identification badges.
- Document visitor details in the Visitor Log (Annexure-2).
5.2 Entry and Exit Procedures
- Entry Procedures:
- All personnel must sanitize hands and wear appropriate Personal Protective Equipment (PPE) before entering the warehouse.
- Security personnel must verify access permissions before allowing entry.
- Record entry times in the Warehouse Entry Log (Annexure-3).
- Exit Procedures:
- Personnel must ensure that no raw materials or unauthorized items are taken out of the warehouse without proper documentation.
- Security must verify exit permissions, and personnel must sign out in the Warehouse Exit Log (Annexure-4).
5.3 Restricted Areas and Special Access
- High-Security Zones:
- Areas storing hazardous, controlled, or high-value materials are designated as high-security zones with restricted access.
- Access to these zones requires additional authorization from the Warehouse Manager and QA Manager.
- Document special access permissions in the Restricted Access Log (Annexure-5).
- Emergency Access:
- In case of emergencies, such as fire or chemical spills, emergency personnel may be granted immediate access with proper documentation.
- Document emergency access events in the Emergency Access Log (Annexure-6).
5.4 Monitoring and Surveillance
- CCTV Monitoring:
- Install CCTV cameras at all entry and exit points, as well as in key storage areas.
- Security personnel must monitor CCTV footage continuously to detect any unauthorized activities.
- Document CCTV checks in the CCTV Monitoring Log (Annexure-7).
- Access Control Systems:
- Implement electronic access control systems (e.g., swipe cards, biometric scanners) for high-security zones.
- Maintain access control records electronically and review them weekly.
- Document access control reviews in the Access Control Review Log (Annexure-8).
5.5 Handling Deviations and Corrective Actions
- Reporting Unauthorized Access:
- Immediately report any instances of unauthorized access or security breaches to the Warehouse Manager and QA.
- Document unauthorized access events in the Unauthorized Access Log (Annexure-9).
- Corrective Actions:
- Investigate the cause of security breaches and implement corrective measures such as revising access protocols or enhancing security systems.
- Document corrective actions in the Corrective Action Log (Annexure-10).
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QA: Quality Assurance
- PPE: Personal Protective Equipment
- CCTV: Closed-Circuit Television
7. Documents
- Authorized Personnel Register (Annexure-1)
- Visitor Log (Annexure-2)
- Warehouse Entry Log (Annexure-3)
- Warehouse Exit Log (Annexure-4)
- Restricted Access Log (Annexure-5)
- Emergency Access Log (Annexure-6)
- CCTV Monitoring Log (Annexure-7)
- Access Control Review Log (Annexure-8)
- Unauthorized Access Log (Annexure-9)
- Corrective Action Log (Annexure-10)
8. References
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
- WHO GMP Guidelines
- ISO 9001:2015 – Quality Management Systems Requirements
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Authorized Personnel Register
| Date | Employee Name | Employee ID | Access Level | Approved By |
|---|---|---|---|---|
| 24/02/2025 | Ravi Kumar | EMP123 | Full Access | Sunita Sharma |
Annexure-2: Visitor Log
| Date | Visitor Name | Organization | Purpose of Visit | Escorted By |
|---|---|---|---|---|
| 24/02/2025 | Dr. Anil Mehra | Regulatory Authority | Inspection | Anjali Mehta |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial Version | New SOP | QA Head |
| 24/02/2025 | 2.0 | Updated Access Control Procedures | Regulatory Compliance | QA Head |