Standard Operating Procedure for Pest Control

1) Purpose

This SOP outlines the procedures for implementing effective pest control measures in pharmaceutical manufacturing facilities to prevent pest infestations and ensure compliance with regulatory standards.

2) Scope

This SOP applies to all areas within the pharmaceutical manufacturing facility where pest control measures are necessary to maintain a pest-free environment.

3) Responsibilities

The Facilities or Engineering department is responsible for managing pest control activities. Quality Assurance (QA) oversees compliance with this SOP and regulatory requirements.

4) Procedure

4.1 Pest Risk Assessment

1. Conduct regular pest risk assessments to identify potential entry points, breeding areas, and conducive conditions for pests.
2. Classify pest risks based on severity and likelihood of occurrence.

4.2 Integrated Pest Management (IPM) Plan

1. Develop and implement an IPM plan tailored to the facility’s specific pest control needs.
2. Include preventive measures, monitoring protocols, and response procedures for pest sightings.

4.3 Pest Monitoring

1. Install and maintain monitoring devices (e.g., traps, baits, sensors) in strategic locations to detect pest activity.
2. Regularly inspect monitoring devices and record findings in pest control logs.

4.4 Pest Exclusion

1. Implement physical barriers and sealing measures to prevent pests from entering the facility.
2. Ensure doors, windows, vents, and other openings are properly sealed and maintained.

4.5 Pest Control Treatments

1. Use approved pest control agents and methods for eradication or management of pests.
2. Follow manufacturer instructions and safety guidelines for the application of pest control treatments.

4.6 Documentation and Reporting

1. Maintain records of pest control activities, including pest sightings, treatments applied, and effectiveness assessments.
2. Report pest control activities and findings to management and Quality Assurance for review and action.

4.7 Training and Awareness

1. Provide training to personnel on pest awareness, identification of pest signs, and reporting procedures.
2. Conduct regular refresher training sessions to reinforce pest control protocols and best practices.

5) Abbreviations, if any

SOP: Standard Operating Procedure
QA: Quality Assurance
IPM: Integrated Pest Management

6) Documents, if any

Pest Risk Assessment Reports, IPM Plan, Pest Control Logs, Training Records

7) Reference, if any

Regulatory guidelines such as EU GMP Annex 1 Manufacture of Sterile Medicinal Products, FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice

8) SOP Version

Version 1.0