SOP Guide for Pharma

SOP for Cleaning and Disinfection of Sampling Tools in Quarantine – V 2.0

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SOP for Cleaning and Disinfection of Sampling Tools in Quarantine – V 2.0

Standard Operating Procedure for Cleaning and Disinfection of Sampling Tools in Quarantine

Department Quality Control / Quality Assurance / Warehouse
SOP No. SOP/RM/081/2025
Supersedes SOP/RM/081/2022
Page No. Page 1 of 15
Issue Date 01/02/2025
Effective Date 05/02/2025
Review Date 01/02/2026

1. Purpose

This Standard Operating Procedure (SOP) outlines the process for the cleaning and disinfection of sampling tools used in the quarantine area. This ensures the prevention of cross-contamination and maintenance of sample integrity, in compliance with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all personnel responsible for using, cleaning, and disinfecting sampling tools such as scoops, sampling thieves, pipettes, and containers used for raw material sampling in the quarantine area.

3. Responsibilities

  • Quality Control (QC) Personnel: Perform cleaning and disinfection procedures, and maintain cleaning records.
  • Warehouse Personnel: Assist in ensuring tools are transported to the designated cleaning areas and stored properly post-cleaning.
  • Quality Assurance (QA): Review and verify compliance with cleaning protocols, and approve cleaning records.

4. Accountability

The QC Manager is responsible for ensuring proper cleaning and disinfection procedures are followed. The QA Manager ensures compliance with SOP and regulatory requirements, and the Warehouse

Manager ensures proper storage of cleaned tools.

5. Procedure

5.1 General Cleaning Guidelines

  1. Designated Cleaning Area:
    • All cleaning and disinfection must be carried out in a designated, controlled environment to prevent contamination.
    • Ensure that cleaning materials and disinfectants are approved by QA.
  2. Personal Protective Equipment (PPE):
    • Personnel must wear appropriate PPE, including gloves, lab coats, face masks, and goggles.
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5.2 Cleaning Procedure

  1. Pre-Cleaning Inspection:
    • Inspect sampling tools for visible contamination or damage.
    • Document the inspection in the Tool Inspection Log (Annexure-1).
  2. Manual Cleaning Process:
    • Disassemble tools (if applicable) for thorough cleaning.
    • Rinse tools with deionized water to remove loose particles.
    • Clean tools using an approved detergent solution and soft brushes to remove residues.
    • Rinse thoroughly with deionized water to ensure no detergent residue remains.
  3. Drying:
    • Dry tools using lint-free wipes or allow to air dry in a clean environment.

5.3 Disinfection Procedure

  1. Approved Disinfectants:
    • Use only QA-approved disinfectants (e.g., 70% isopropyl alcohol, hydrogen peroxide solutions).
    • Ensure the disinfectant is compatible with the material of the sampling tools.
  2. Disinfection Steps:
    • Apply the disinfectant to all surfaces of the cleaned tools using sterile wipes or by immersion (if applicable).
    • Allow the disinfectant to contact the surfaces for the required dwell time (as per disinfectant manufacturer instructions).
    • Rinse tools with sterile deionized water if required by the disinfectant instructions.
  3. Post-Disinfection Handling:
    • Transfer tools to a sterile drying area and allow them to dry completely.
    • Document the disinfection process in the Cleaning and Disinfection Log (Annexure-2).

5.4 Storage of Cleaned Tools

  1. Storage Conditions:
    • Store cleaned and disinfected tools in designated, labeled storage cabinets or sterile containers.
    • Ensure tools are protected from dust, moisture, and other contaminants.
  2. Storage Documentation:
    • Document the storage location and status of tools in the Tool Storage Log (Annexure-3).
See also  SOP for Coordination with Procurement Department During Raw Material Receipt - V 2.0

5.5 Handling Deviations in Cleaning and Disinfection

  1. Deviation Reporting:
    • Report any deviations from the cleaning procedure to the QA Manager.
    • Document deviations in the Cleaning Deviation Report (Annexure-4).
  2. Corrective Actions:
    • Investigate and rectify the root cause of the deviation.
    • Document corrective actions in the Corrective Action Log (Annexure-5).

5.6 Training and Compliance

  1. Personnel Training:
    • All personnel must be trained in the proper cleaning and disinfection procedures before handling sampling tools.
    • Document training in the Training Log (Annexure-6).
  2. Compliance Monitoring:
    • QA must conduct regular audits to ensure adherence to cleaning protocols.
    • Document audit findings in the Compliance Audit Log (Annexure-7).

6. Abbreviations

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

7. Documents

  1. Tool Inspection Log (Annexure-1)
  2. Cleaning and Disinfection Log (Annexure-2)
  3. Tool Storage Log (Annexure-3)
  4. Cleaning Deviation Report (Annexure-4)
  5. Corrective Action Log (Annexure-5)
  6. Training Log (Annexure-6)
  7. Compliance Audit Log (Annexure-7)

8. References

  • 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
  • ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
  • EU Guidelines on Good Distribution Practices (GDP)

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department
See also  SOP for Quarantine Area Entry Restrictions and Security Measures - V 2.0

11. Annexures

Annexure-1: Tool Inspection Log

Date Tool Name Condition Inspected By Remarks
01/02/2025 Sampling Thief No Visible Damage Ravi Kumar Ready for Cleaning

Annexure-2: Cleaning and Disinfection Log

Date Tool Name Cleaning Method Disinfectant Used Cleaned By Verified By (QA)
01/02/2025 Sampling Thief Manual Wash 70% Isopropyl Alcohol Sunita Sharma Anjali Mehta

Annexure-3: Tool Storage Log

Date Tool Name Storage Location Stored By Verified By (QA)
01/02/2025 Sampling Thief Sterile Cabinet A Ajay Singh Anjali Mehta

Annexure-4: Cleaning Deviation Report

Date Tool Name Deviation Description Reported By
02/02/2025 Sampling Thief Missed Disinfection Step Ravi Kumar

Annexure-5: Corrective Action Log

Date Deviation Description Corrective Action Implemented By Verified By (QA)
03/02/2025 Missed Disinfection Step Re-cleaned and Disinfected Ajay Singh Anjali Mehta

Annexure-6: Training Log

Date Training Topic Trainer Attendee Name Signature
04/02/2025 Cleaning and Disinfection Procedures Health & Safety Officer Sunita Sharma

Annexure-7: Compliance Audit Log

Date Audit Type Findings Corrective Actions Taken Audited By
05/02/2025 Cleaning Compliance Incomplete Documentation Updated Cleaning Logs 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
01/02/2025 2.0 Updated Cleaning and Disinfection Procedures Regulatory Compliance QA Head
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