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 |