SOP Guide for Pharma

SOP for Cleaning and Sanitization of Raw Material Storage Racks – V 2.0

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SOP for Cleaning and Sanitization of Raw Material Storage Racks – V 2.0

Standard Operating Procedure for Cleaning and Sanitization of Raw Material Storage Racks

Department Warehouse / Quality Assurance
SOP No. SOP/RM/123/2025
Supersedes SOP/RM/123/2022
Page No. Page 1 of 15
Issue Date 21/02/2025
Effective Date 25/02/2025
Review Date 21/02/2026

1. Purpose

This Standard Operating Procedure (SOP) outlines the methods for cleaning and sanitizing raw material storage racks to prevent contamination, ensure product quality, and maintain compliance with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all storage racks in the raw material warehouse, including racks for APIs, excipients, solvents, and other raw materials.

3. Responsibilities

4. Accountability

The Warehouse Manager is accountable for the execution of cleaning and sanitization procedures, while the QA Manager ensures compliance with regulatory standards and documentation accuracy.

5. Procedure

5.1 Cleaning Schedule

  1. Routine Cleaning:
    • Clean storage racks weekly using approved cleaning agents.
    • Perform additional cleaning after spills, product changes, or any contamination incidents.
    • Document all cleaning activities in the Cleaning Schedule Log (Annexure-1).
  2. Deep Cleaning:
    • Conduct deep cleaning of storage racks quarterly, including hard-to-reach areas.
    • Disassemble racks if necessary to ensure thorough cleaning.
    • Record deep cleaning activities in the Deep Cleaning Log (Annexure-2).
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5.2 Cleaning and Sanitization Procedures

  1. Preparation:
    • Remove all raw materials from the storage racks before cleaning.
    • Wear appropriate Personal Protective Equipment (PPE), including gloves, masks, and goggles.
    • Ensure cleaning agents and sanitizers are approved by QA and compatible with stored materials.
  2. Cleaning Process:
    • Dust and wipe down racks using lint-free cloths to remove loose particles.
    • Apply cleaning agents to all surfaces and scrub using non-abrasive brushes.
    • Wipe surfaces with clean water to remove any residue from cleaning agents.
    • Document the cleaning process in the Cleaning Log (Annexure-3).
  3. Sanitization Process:
    • Apply approved sanitizers to all surfaces, ensuring complete coverage.
    • Allow sanitizers to air dry or wipe dry with sterile cloths, depending on the material compatibility.
    • Document the sanitization process in the Sanitization Log (Annexure-4).

5.3 Post-Cleaning Inspection

  1. Visual Inspection:
    • Conduct a visual inspection of the cleaned racks to ensure no residue or contaminants remain.
    • Check for signs of rust, corrosion, or damage to the racks.
    • Document inspections in the Post-Cleaning Inspection Log (Annexure-5).
  2. QA Verification:
    • QA personnel must verify the cleaning and sanitization records and inspect selected racks.
    • Document QA verification in the QA Verification Log (Annexure-6).
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5.4 Handling of Deviations

  1. Deviation Reporting:
    • Report any deviations, such as incomplete cleaning, improper sanitization, or damaged racks, immediately to the Warehouse Manager and QA.
    • Document deviations in the Deviation Log (Annexure-7).
  2. Corrective Actions:
    • Investigate the cause of deviations and implement corrective actions such as re-cleaning, replacing damaged racks, or retraining staff.
    • Document corrective actions in the Corrective Action Log (Annexure-8).

6. Abbreviations

7. Documents

  1. Cleaning Schedule Log (Annexure-1)
  2. Deep Cleaning Log (Annexure-2)
  3. Cleaning Log (Annexure-3)
  4. Sanitization Log (Annexure-4)
  5. Post-Cleaning Inspection Log (Annexure-5)
  6. QA Verification Log (Annexure-6)
  7. Deviation Log (Annexure-7)
  8. Corrective Action Log (Annexure-8)

8. References

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

See also  SOP for Chain of Custody Documentation for Sampled Quarantine Materials - V 2.0

Annexure-1: Cleaning Schedule Log

Date Rack ID Cleaning Performed By Remarks
21/02/2025 Rack-01 Ravi Kumar Routine Cleaning Completed

Annexure-2: Deep Cleaning Log

Date Rack ID Deep Cleaning Performed By Remarks
15/02/2025 Rack-03 Sunita Sharma Deep Cleaning Completed

Annexure-3: Cleaning Log

Date Rack ID Cleaning Agent Used Performed By
21/02/2025 Rack-02 70% IPA Anjali Mehta

Annexure-4: Sanitization Log

Date Rack ID Sanitizer Used Performed By
21/02/2025 Rack-01 Hydrogen Peroxide 3% Ravi Kumar

Annexure-5: Post-Cleaning Inspection Log

Date Rack ID Inspected By Findings
21/02/2025 Rack-01 Sunita Sharma No Residue Detected

Annexure-6: QA Verification Log

Date Rack ID Verified By Remarks
21/02/2025 Rack-02 Anjali Mehta Verified and Approved

Annexure-7: Deviation Log

Date Rack ID Deviation Reported By
20/02/2025 Rack-04 Incomplete Cleaning Detected Ravi Kumar

Annexure-8: Corrective Action Log

Date Rack ID Corrective Action Taken Performed By
20/02/2025 Rack-04 Re-cleaned and Inspected Sunita Sharma

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial Version New SOP QA Head
21/02/2025 2.0 Updated Cleaning and Sanitization Procedures Regulatory Compliance QA Head
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