Standard Operating Procedure for Pest Control and Management in GMP Areas
1) Purpose
This SOP outlines the procedures for pest control and management in GMP areas to ensure a clean and contamination-free manufacturing environment.
2) Scope
This SOP applies to all personnel responsible for pest control in GMP areas at [Company Name].
3) Responsibilities
- Pest Control Operators: Perform regular inspections and implement pest control measures.
- Maintenance Team: Ensure that building integrity is maintained to prevent pest entry.
- Quality Assurance (QA): Review pest control logs and ensure compliance with regulatory standards.
4) Procedure
4.1 Pest Control Measures
4.1.1 Regular Inspections
- Inspect GMP areas for signs of pests at least once per week, including storage areas, loading docks, and production facilities. Use traps and monitoring devices to detect infestations.
- Document the results of the inspections in the pest control log.
4.1.2 Pest Prevention Measures
- Ensure that all entry points, including doors and windows, are sealed properly to prevent pest entry. Install mesh screens where necessary.
- Maintain a clean environment by regularly disposing of waste and ensuring proper storage of raw materials.
4.1.3 Pest Control Applications
- If pests are detected, use approved pest control chemicals or traps according to the product’s label instructions. Only certified personnel may apply pest control measures.
- Ensure that all pest control applications are documented in the pest control log, including the date, type of pest control used, and location.
4.2 Post-Operation Activities
4.2.1 Reporting and Documentation
- Record all pest control measures, inspections, and actions taken in the pest control log. Submit documentation to QA for review weekly.
- If a pest infestation is found, supervisors must notify QA immediately and implement corrective actions to prevent further contamination.
4.2.2 Maintenance of Pest Control Equipment
- Ensure that pest control traps, monitoring devices, and equipment are maintained and cleaned regularly. Replace any worn-out traps or damaged equipment as needed.
- Document the maintenance of pest control equipment in the equipment maintenance log.
5) Abbreviations, if any
- GMP: Good Manufacturing Practices
- QA: Quality Assurance
6) Documents, if any
- Pest Control Log
- Equipment Maintenance Log
7) References, if any
- Internal SOP for pest control
8) SOP Version
Version 1.0
Annexure
1. Pest Control Log Template
| Date | Area Inspected | Pest Type (if detected) | Action Taken | Operator Initials | QA Approval |
|---|---|---|---|---|---|
| DD/MM/YYYY | Room/Facility Inspected | Type of Pest Detected | Control Measures Taken | Operator Name | QA Name |