SOP Guide for Pharma

SOP for Raw Material Storage Area Cleaning and Maintenance – V 2.0

SOP for Raw Material Storage Area Cleaning and Maintenance – V 2.0

Standard Operating Procedure for Cleaning and Maintenance of Raw Material Storage Areas

Department Warehouse / Quality Assurance
SOP No. SOP/RM/117/2025
Supersedes SOP/RM/117/2022
Page No. Page 1 of 15
Issue Date 17/02/2025
Effective Date 21/02/2025
Review Date 17/02/2026

1. Purpose

This Standard Operating Procedure (SOP) outlines the cleaning and maintenance protocols for raw material storage areas to ensure a clean, contamination-free environment in compliance with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all raw material storage areas within the warehouse, including general storage zones, temperature-controlled rooms, hazardous material sections, and quarantine zones.

3. Responsibilities

  • Warehouse Personnel: Perform routine cleaning, report maintenance issues, and ensure cleanliness standards are upheld.
  • Quality Assurance (QA): Inspect and verify the cleanliness and maintenance status of storage areas.
  • Warehouse Manager: Supervise cleaning and maintenance activities, ensure staff are trained, and coordinate repairs.

4. Accountability

The Warehouse Manager is accountable for implementing cleaning schedules and ensuring maintenance protocols are followed, while the QA Manager ensures compliance through inspections and audits.

5. Procedure

5.1 Cleaning Schedule and Frequency

  1. Daily Cleaning:
    • Sweep floors, remove dust, and dispose of any waste material
at the end of each shift.
  • Wipe down high-touch surfaces such as door handles and light switches with disinfectant.
  • Document activities in the Daily Cleaning Log (Annexure-1).
  • Weekly Cleaning:
    • Clean storage racks, pallets, and shelving units using appropriate cleaning agents.
    • Check for and remove any pest infestations or mold growth.
    • Document weekly activities in the Weekly Cleaning Log (Annexure-2).
  • Monthly Deep Cleaning:
    • Conduct deep cleaning of the entire storage area, including walls, ceilings, and ventilation systems.
    • Use approved cleaning agents that are non-reactive with stored materials.
    • Document deep cleaning activities in the Monthly Deep Cleaning Log (Annexure-3).
  • 5.2 Cleaning Procedures

    1. General Cleaning Protocol:
      • Wear Personal Protective Equipment (PPE) as required, including gloves, masks, and protective clothing.
      • Use designated cleaning equipment (e.g., mops, brooms, vacuums) for specific storage zones to prevent cross-contamination.
      • Ensure all cleaning agents are labeled and stored separately from raw materials.
    2. Spill Management:
      • Immediately clean any spills using appropriate spill kits and notify the Warehouse Manager.
      • Document spills and corrective actions in the Spill Cleaning Log (Annexure-4).

    5.3 Maintenance of Storage Areas

    1. Routine Maintenance:
      • Inspect storage racks, shelving units, and pallets weekly for structural integrity.
      • Ensure temperature and humidity control systems are functioning correctly.
      • Document routine maintenance activities in the Maintenance Log (Annexure-5).
    2. Repairs and Replacements:
      • Report damaged racks, flooring, or environmental control systems immediately to the Warehouse Manager.
      • Coordinate with maintenance teams to repair or replace faulty equipment.
      • Document all repairs and replacements in the Repair Log (Annexure-6).

    5.4 Handling of Deviations

    1. Deviation Detection:
      • Identify deviations such as unclean surfaces, pest infestations, or malfunctioning equipment during routine checks.
      • Isolate affected areas and materials to prevent contamination.
      • Document deviations in the Deviation Log (Annexure-7).
    2. Corrective Actions:
      • Initiate immediate corrective actions, including re-cleaning, fumigation, or equipment repair.
      • Document corrective actions in the Corrective Action Log (Annexure-8).

    5.5 Verification and Compliance Monitoring

    1. QA Inspections:
      • QA will conduct monthly inspections to verify cleaning and maintenance activities.
      • Document inspection findings in the QA Inspection Log (Annexure-9).
    2. Compliance Audits:
      • Conduct quarterly compliance audits to ensure adherence to GMP standards.
      • Document audit results in the Compliance Audit Log (Annexure-10).

    6. Abbreviations

    • SOP: Standard Operating Procedure
    • GMP: Good Manufacturing Practice
    • QA: Quality Assurance
    • PPE: Personal Protective Equipment

    7. Documents

    1. Daily Cleaning Log (Annexure-1)
    2. Weekly Cleaning Log (Annexure-2)
    3. Monthly Deep Cleaning Log (Annexure-3)
    4. Spill Cleaning Log (Annexure-4)
    5. Maintenance Log (Annexure-5)
    6. Repair Log (Annexure-6)
    7. Deviation Log (Annexure-7)
    8. Corrective Action Log (Annexure-8)
    9. QA Inspection Log (Annexure-9)
    10. Compliance Audit Log (Annexure-10)

    8. References

    • 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
    • WHO GMP Guidelines
    • OSHA Standards for Workplace Safety

    9. SOP Version

    Version: 2.0

    10. Approval Section

    Prepared By Checked By Approved By
    Signature
    Date
    Name
    Designation
    Department

    11. Annexures

    Annexure-1: Daily Cleaning Log

    Date Area Cleaned Cleaning Method Performed By
    17/02/2025 General Storage Area Sweeping and Dusting Ravi Kumar

    Annexure-2: Weekly Cleaning Log

    Date Area Cleaned Cleaning Method Performed By
    17/02/2025 Storage Racks Wiping with Disinfectant Sunita Sharma

    Annexure-3: Monthly Deep Cleaning Log

    Date Area Cleaned Cleaning Method Performed By
    01/02/2025 Entire Warehouse Deep Cleaning with Approved Agents Anjali Mehta

    Annexure-4: Spill Cleaning Log

    Date Spill Type Area Affected Action Taken Performed By
    15/02/2025 Chemical Spill Hazardous Storage Area Used Spill Kit and Ventilated Area Ravi Kumar

    Annexure-5: Maintenance Log

    Date Equipment/Area Maintenance Activity Performed By
    16/02/2025 Temperature Control System Filter Replacement Anjali Mehta

    Annexure-6: Repair Log

    Date Area Repaired Issue Repair Details Performed By
    14/02/2025 Storage Rack Bent Support Reinforced Rack Structure Sunita Sharma

    Annexure-7: Deviation Log

    Date Deviation Corrective Action Reported By
    13/02/2025 Unclean Floor Detected Re-cleaned Area Ravi Kumar

    Annexure-8: Corrective Action Log

    Date Issue Corrective Action Taken Performed By
    12/02/2025 Pest Infestation Fumigation Ravi Kumar

    Annexure-9: QA Inspection Log

    Date Area Inspected Findings Corrective Actions Inspected By
    10/02/2025 General Storage Area No Issues Detected N/A Anjali Mehta

    Annexure-10: Compliance Audit Log

    Date Audit Type Findings Corrective Actions Audited By
    01/02/2025 Storage Area Cleaning Audit Compliant N/A Anjali Mehta

    Revision History:

    Revision Date Revision No. Revision Details Reason for Revision Approved By
    01/01/2024 1.0 Initial Version New SOP QA Head
    17/02/2025 2.0 Updated Cleaning and Maintenance Procedures Regulatory Compliance QA Head
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