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Quality Assurance: SOP for Pest Control

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SOP for Pest Control

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.
See also  Quality Assurance: SOP for Change Management in Gels Production

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.
  • 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

    See also  SOP for Documentation Control
    Quality Assurance Tags:Batch Record Review SOP, CAPA SOP (Corrective and Preventive Actions), Change Control Management SOP, Cleaning Validation SOP, Documentation Control SOP, Equipment Qualification SOP, Finished Product Quality Assurance, Good Documentation Practices SOP, Handling Deviations SOP, In-process Quality Control SOP, Internal Quality Audits SOP, Out-of-Specification SOP, Packaging Material Quality Control, Pharmaceutical quality assurance SOP, Process Validation SOP, Product Complaint Handling SOP, Product Recall Management SOP, Quality Assurance Audits SOP, Quality Control Sample Management, Quality Risk Management SOP, Serialization and Traceability SOP, SOP for Raw Material Quality Assurance, Supplier Qualification SOP, Training and Competency Assessment SOP, Vendor Audits SOP

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    Standard Operating Procedures V 1.0

    • Aerosols
    • Analytical Method Development
    • Bioequivalence Bioavailability Study
    • Capsule Formulation
    • Clinical Studies
    • Creams
    • Data Integrity
    • Dental Dosage Forms
    • Drug Discovery
    • Environment, Health and Safety
    • Formulation Development
    • Gels
    • Good Distribution Practice
    • Good Warehousing Practices
    • In-Process Control
    • Injectables
    • Liquid Orals
    • Liposome and Emulsion Formulations
    • Lotions
    • Lyophilized Products
    • Maintenance Dept.
    • Medical Devices
    • Metered-Dose Inhaler
    • Microbiology Testing
    • Nanoparticle Formulation
    • Nasal Spray Formulations
    • Nebulizers
    • Ocular (Eye) Dosage Forms
    • Ointments
    • Otic (Ear) Dosage Forms
    • Pharmacovigilance
    • Powder & Granules
    • Purchase Departments
    • Quality Assurance
    • Quality Control
    • Raw Material Stores
    • Regulatory Affairs
    • Tablet Manufacturing
    • Rectal Dosage Forms
    • Transdermal Patches
    • Vaginal Dosage Forms
    • Validations and Qualifications

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    NEW! Revised SOPs – V 2.0

    • Aerosols V 2.0
    • Analytical Method Development V 2.0
    • API Manufacturing V 2.0
    • BA-BE Studies V 2.0
    • Biosimilars V 2.0
    • Capsules V 2.0
    • Creams V 2.0
    • Elixers V 2.0
    • Ointments V 2.0
    • Raw Material Warehouse V 2.0
    • Tablet Manufacturing V2.0

    New Publication: A must for All.

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