Standard Operating Procedure for Prevention of Infestation in Raw Material Storage Areas
| Department | Warehouse / Quality Assurance / Pest Control |
|---|---|
| SOP No. | SOP/RM/137/2025 |
| Supersedes | SOP/RM/137/2022 |
| Page No. | Page 1 of 15 |
| Issue Date | 01/03/2025 |
| Effective Date | 07/03/2025 |
| Review Date | 01/03/2026 |
1. Purpose
This Standard Operating Procedure (SOP) establishes guidelines for the prevention, detection, and control of pest infestation in raw material storage areas to ensure material quality, safety, and compliance with Good Manufacturing Practices (GMP).
2. Scope
This SOP applies to all raw material storage areas within the warehouse, including storage zones for APIs, excipients, solvents, and other chemicals. It covers routine inspections, pest control measures, and documentation protocols.
3. Responsibilities
- Warehouse Personnel: Conduct regular inspections for signs of pest activity and maintain cleanliness in storage areas.
- Pest Control Team: Implement and monitor pest control measures, including fumigation and trapping, as per schedule.
- Warehouse Manager: Supervise pest control activities and ensure compliance with this SOP.
- Quality Assurance (QA): Review pest control documentation and ensure compliance with GMP standards.
4. Accountability
The Warehouse Manager is accountable for ensuring that pest control procedures are implemented and adhered to. The QA Manager is
responsible for reviewing and verifying that the storage environment meets regulatory standards.
5. Procedure
5.1 Pest Control Measures
- Initial Assessment and Setup:
- Conduct an initial pest risk assessment to identify potential entry points, breeding grounds, and vulnerable storage areas.
- Install appropriate pest control devices such as traps, bait stations, and insect light traps in strategic locations.
- Document the initial assessment in the Pest Risk Assessment Log (Annexure-1).
- Routine Pest Control Activities:
- Schedule and conduct regular pest control activities, including fumigation, baiting, and spraying, in compliance with local regulations.
- Ensure pest control chemicals are approved for use in pharmaceutical environments and are stored properly.
- Record pest control activities in the Pest Control Activity Log (Annexure-2).
5.2 Routine Inspection of Storage Areas
- Daily Visual Inspections:
- Conduct daily visual inspections of storage areas for signs of pest activity, such as droppings, gnaw marks, or insect presence.
- Inspect storage containers and surrounding areas for any breach that may allow pest entry.
- Document daily inspections in the Pest Inspection Log (Annexure-3).
- Monthly Comprehensive Inspections:
- Perform comprehensive monthly inspections, including reviewing pest control devices for effectiveness and monitoring records.
- Identify and document any pest activity trends or recurring issues for corrective action.
- Record findings in the Comprehensive Inspection Log (Annexure-4).
5.3 Corrective Actions for Pest Infestation
- Immediate Response to Infestation:
- In case of confirmed pest infestation, immediately quarantine affected materials and areas.
- Notify the Warehouse Manager, QA, and Pest Control Team for urgent corrective action.
- Document infestations and actions in the Infestation Incident Log (Annexure-5).
- Root Cause Analysis and Prevention:
- Conduct a root cause analysis to determine the source of infestation and implement preventive measures.
- Modify storage or facility management practices to prevent recurrence.
- Record corrective actions in the Corrective Action Log (Annexure-6).
5.4 Documentation and Review
- Record-Keeping Requirements:
- Maintain all pest control records, inspection logs, and corrective action reports for a minimum of five years.
- Ensure records are readily available for internal audits and regulatory inspections.
- Document record retention details in the Record Retention Log (Annexure-7).
- Review and Continuous Improvement:
- QA will review pest control effectiveness quarterly and recommend improvements as needed.
- Conduct periodic training for warehouse personnel on pest prevention and control procedures.
- Document reviews and training sessions in the Pest Control Review Log (Annexure-8).
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QA: Quality Assurance
- PPE: Personal Protective Equipment
7. Documents
- Pest Risk Assessment Log (Annexure-1)
- Pest Control Activity Log (Annexure-2)
- Pest Inspection Log (Annexure-3)
- Comprehensive Inspection Log (Annexure-4)
- Infestation Incident Log (Annexure-5)
- Corrective Action Log (Annexure-6)
- Record Retention Log (Annexure-7)
- Pest Control Review Log (Annexure-8)
8. References
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
- WHO GMP Guidelines
- ISO 9001:2015 – Quality Management Systems Requirements
- Local Health and Safety Regulations for Pest Control
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Pest Risk Assessment Log
| Date | Area Assessed | Risk Identified | Control Measure Suggested | Assessed By |
|---|---|---|---|---|
| 01/03/2025 | Storage Zone A | Open windows | Install mesh screens | Ravi Kumar |
Annexure-2: Pest Control Activity Log
| Date | Activity Performed | Location | Performed By | Comments |
|---|---|---|---|---|
| 02/03/2025 | Fumigation | Cold Storage Room | Neha Verma | Completed successfully |
Annexure-3: Pest Inspection Log
| Date | Area Inspected | Signs of Infestation | Inspection Result | Inspected By |
|---|---|---|---|---|
| 03/03/2025 | Warehouse Zone B | None | Clear | Sunita Sharma |
| 03/03/2025 | Cold Storage Room 1 | Droppings near pallet rack | Quarantine initiated | Ravi Kumar |
Annexure-4: Comprehensive Inspection Log
| Date | Area Inspected | Inspection Type | Findings | Corrective Actions | Inspected By |
|---|---|---|---|---|---|
| 01/03/2025 | Loading Dock | Monthly | Trap missing | Replaced trap | Neha Verma |
| 01/03/2025 | API Storage Area | Monthly | Insect activity detected | Sprayed insecticide, sealed entry point | Amit Joshi |
Annexure-5: Infestation Incident Log
| Date | Material Affected | Location | Description of Infestation | Action Taken | Reported By |
|---|---|---|---|---|---|
| 04/03/2025 | Excipients (Batch 4567) | Cold Storage Room 1 | Rodent droppings near pallet | Material quarantined, area fumigated | Ravi Kumar |
| 05/03/2025 | Solvent C (Batch 7890) | Warehouse Zone C | Gnaw marks on packaging | Material disposed, pest control reinforced | Neha Verma |
Annexure-6: Corrective Action Log
| Date | Deviation Description | Corrective Action Taken | Implemented By | Verified By |
|---|---|---|---|---|
| 05/03/2025 | Rodent activity in Cold Storage Room 1 | Fumigation, sealing of entry points | Amit Joshi | Priya Singh (QA) |
| 06/03/2025 | Trap missing in Loading Dock | Trap replaced, monitoring increased | Ravi Kumar | Rajeev Menon (QA) |
Annexure-7: Record Retention Log
| Date | Document Name | Retention Period | Stored By | Storage Location |
|---|---|---|---|---|
| 06/03/2025 | Pest Inspection Log | 5 Years | Priya Singh | Document Control Room A |
| 06/03/2025 | Infestation Incident Log | 5 Years | Rajeev Menon | Document Control Room B |
Annexure-8: Pest Control Review Log
| Date | Review Type | Findings | Recommendations | Reviewed By |
|---|---|---|---|---|
| 06/03/2025 | Quarterly Review | Rodent activity in cold storage recurring | Increase fumigation frequency | Priya Singh (QA) |
| 06/03/2025 | Annual Review | Pest control measures effective in dry storage | Maintain current procedures | Rajeev Menon (QA) |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial Version | New SOP | QA Head |
| 01/03/2025 | 2.0 | Updated pest control procedures and inspection frequency | Regulatory compliance and improved pest control effectiveness | QA Head |