Standard Operating Procedure for Pest Control and Monitoring Program in API Manufacturing
| Department | API Manufacturing |
|---|---|
| SOP No. | SOP/API/016/2025 |
| Supersedes | SOP/API/016/2022 |
| Page No. | Page 1 of 10 |
| Issue Date | 13/04/2025 |
| Effective Date | 15/04/2025 |
| Review Date | 13/04/2026 |
1. Purpose
To establish a consistent and controlled pest control and monitoring program within the API manufacturing facility to ensure a hygienic environment and prevent contamination of materials and products.
2. Scope
This SOP applies to all areas of the API manufacturing site, including warehouses, production zones, sampling rooms, utility areas, and external perimeters where pest activity could pose a risk.
3. Responsibilities
- Warehouse/Production Staff: Identify and report signs of pest activity immediately to QA and EHS.
- Pest Control Contractor: Conduct preventive and corrective pest control as per schedule.
- QA Officer: Monitor records, trends, and audit pest control activities for GMP compliance.
4. Accountability
The EHS Manager is accountable for implementing and maintaining the pest control program, while the QA Manager ensures its compliance with GMP standards.
5. Procedure
5.1 Selection of Pest Control Service Provider
- Only licensed, GMP-compliant pest control service providers shall be contracted.
- Service provider shall submit:
- Service contract
- Material safety data sheets (MSDS) for chemicals used
- Pest control layout plan
5.2 Pest Control Schedule
- Activities include:
- Rodent baiting – Monthly
- Insecticidal spray – Fortnightly
- Glue trap replacement – Weekly
- Fogging (if required) – Quarterly or during infestation
- Display the “Pest Control Calendar” at entrance of each zone (Annexure-1).
5.3 Monitoring Tools
- Place pest control devices at:
- Entry/Exit points
- Raw material and finished goods storage areas
- Utility and HVAC rooms
- Drainage and wash areas
- Assign device IDs as per location (e.g., RT01, GT05).
- Maintain “Pest Control Monitoring Log” (Annexure-2) after each visit.
5.4 Record Review and Trending
- QA to review the pest activity reports monthly for:
- Pest type and location
- Repetition of activity
- Corrective action implemented
- Initiate “Pest Incident Investigation Form” (Annexure-3) for repeated activity in same location.
- Evaluate need for fogging or increased frequency based on trend.
5.5 Precautions During Pesticide Application
- Ensure materials are covered or removed before pesticide application.
- Do not spray in open production or sampling areas during operational hours.
- Post signage during fogging or chemical application: “PESTICIDE IN USE – ENTRY RESTRICTED.”
6. Abbreviations
- SOP: Standard Operating Procedure
- MSDS: Material Safety Data Sheet
- GMP: Good Manufacturing Practice
- QA: Quality Assurance
- EHS: Environment, Health & Safety
7. Documents
- Pest Control Calendar (Annexure-1)
- Pest Control Monitoring Log (Annexure-2)
- Pest Incident Investigation Form (Annexure-3)
8. References
- ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
- WHO TRS 961 – Annex 9: Good Storage and Distribution Practices
- 21 CFR Part 211.56 – Sanitation
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 Control Calendar
| Month | Service Date | Service Type | Area Covered | Performed By |
|---|---|---|---|---|
| April 2025 | 05/04/2025 | Rodent Baiting | Warehouse & Utility |
Annexure-2: Pest Control Monitoring Log
| Date | Device ID | Location | Pest Count | Corrective Action | Remarks |
|---|---|---|---|---|---|
| 12/04/2025 | RT03 | Raw Material Bay | 2 | Glue Trap Replaced | Rodents observed |
Annexure-3: Pest Incident Investigation Form
| Date | Location | Type of Pest | Investigation Summary | Corrective Action | Verified By |
|---|---|---|---|---|---|
| 10/04/2025 | Sampling Room | Cockroach | Drain opening near entry point | Sealed drain, repeated fogging |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2022 | 1.0 | Initial Release | GMP Requirement | QA Head |
| 13/04/2025 | 2.0 | Added Incident Investigation Annexure | Audit Observation | QA Head |