SOP Guide for Pharma

SOP for Use of Safety Equipment While Handling Quarantined Chemicals – V 2.0

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SOP for Use of Safety Equipment While Handling Quarantined Chemicals – V 2.0

Standard Operating Procedure for Use of Safety Equipment While Handling Quarantined Chemicals

Department Warehouse / Quality Assurance / Health & Safety
SOP No. SOP/RM/077/2025
Supersedes SOP/RM/077/2022
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 proper use of safety equipment while handling quarantined chemicals to ensure personnel safety, prevent contamination, and maintain compliance with Good Manufacturing Practices (GMP) and health & safety regulations.

2. Scope

This SOP applies to all personnel involved in handling quarantined chemicals, including Active Pharmaceutical Ingredients (APIs), solvents, hazardous raw materials, and temperature-sensitive substances stored in the quarantine area.

3. Responsibilities

  • Warehouse Personnel: Utilize appropriate personal protective equipment (PPE) when handling quarantined chemicals and follow safety procedures.
  • Quality Assurance (QA): Ensure compliance with safety protocols and inspect safety equipment regularly.
  • Health & Safety Officer: Provide training, maintain safety equipment, and oversee compliance with safety standards.

4. Accountability

The Warehouse Manager is responsible for ensuring proper use of safety equipment. The QA Manager ensures procedural compliance, while the Health & Safety Officer oversees training and equipment maintenance.

5. Procedure

5.1 Personal Protective Equipment (PPE) Requirements

  1. Mandatory PPE:
    • Lab Coats or Chemical-Resistant Gowns
    • Nitrile or Neoprene Gloves
    • Safety Goggles or Face Shields
    • Respirators (for volatile or toxic chemicals)
    • Shoe Covers or Chemical-Resistant Footwear
  2. PPE Selection Based on Material:
    • Corrosive Chemicals: Use full-face shields, chemical-resistant aprons, and neoprene gloves.
    • Volatile Solvents: Use respirators with organic vapor cartridges and safety goggles.
    • Toxic Substances: Use full-body suits with self-contained breathing apparatus (SCBA) if required.
See also  SOP for Accepting and Handling of Herbal Raw Materials - V 2.0

5.2 Procedure for Using Safety Equipment

  1. Pre-Use Inspection:
    • Inspect all PPE before use for signs of wear, tear, or contamination.
    • Document inspection results in the PPE Inspection Log (Annexure-1).
  2. Donning PPE:
    • Follow the PPE Donning Sequence:
      1. Wear lab coat or gown.
      2. Put on gloves, ensuring cuffs cover the sleeves.
      3. Wear safety goggles or face shield.
      4. Put on respirators if handling volatile or hazardous chemicals.
      5. Use shoe covers or chemical-resistant footwear.
    • Ensure PPE fits securely and provides full coverage.
  3. Doffing PPE:
    • Follow the PPE Removal Sequence to avoid contamination:
      1. Remove gloves and dispose of them in hazardous waste bins.
      2. Remove goggles or face shield carefully to avoid splashes.
      3. Take off lab coat or gown and dispose of or place in designated decontamination bins.
      4. Remove respirator last, following proper decontamination procedures if reusable.

5.3 Maintenance and Storage of Safety Equipment

  1. Post-Use Cleaning:
    • Clean reusable PPE (e.g., goggles, respirators) with appropriate disinfectants after each use.
    • Document cleaning activities in the PPE Cleaning Log (Annexure-2).
  2. Storage:
    • Store PPE in designated, clean, and dry areas away from direct sunlight and contaminants.
    • Ensure respirators and face shields are stored in sealed containers to prevent contamination.
See also  SOP for Receiving Raw Materials from Different Manufacturers of the Same API - V 2.0

5.4 Emergency Procedures

  1. Chemical Spills or Exposure:
    • In case of accidental exposure, immediately remove contaminated PPE and rinse the affected area with water for at least 15 minutes.
    • Report the incident to the Health & Safety Officer and document it in the Incident Report Log (Annexure-3).
  2. Respiratory Distress:
    • If respiratory distress occurs, move to a well-ventilated area immediately and seek medical attention.
    • Document the incident and review the effectiveness of the respirator used.

5.5 Training and Compliance

  1. Training Sessions:
    • Conduct bi-annual training sessions on the proper use of PPE and handling quarantined chemicals.
    • Document attendance and training completion in the PPE Training Log (Annexure-4).
  2. Compliance Monitoring:
    • QA and Health & Safety teams must conduct random audits to ensure compliance with PPE protocols.
    • Document audit results and corrective actions in the Compliance Audit Log (Annexure-5).

6. Abbreviations

  • SOP: Standard Operating Procedure
  • GMP: Good Manufacturing Practice
  • QA: Quality Assurance
  • PPE: Personal Protective Equipment
  • SCBA: Self-Contained Breathing Apparatus

7. Documents

  1. PPE Inspection Log (Annexure-1)
  2. PPE Cleaning Log (Annexure-2)
  3. Incident Report Log (Annexure-3)
  4. PPE Training Log (Annexure-4)
  5. Compliance Audit Log (Annexure-5)

8. References

  • 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
  • OSHA 29 CFR 1910 – Occupational Safety and Health Standards
  • ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
See also  SOP for Inspection of Incoming Raw Materials Packaging - V 2.0

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: PPE Inspection Log

Date Equipment Type Condition Inspected By Remarks
01/02/2025 Respirator Good Ravi Kumar No Issues

Annexure-2: PPE Cleaning Log

Date Equipment Type Cleaning Method Cleaned By Verified By (QA)
01/02/2025 Face Shield Disinfectant Wipe Sunita Sharma Anjali Mehta

Annexure-3: Incident Report Log

Date Incident Description Material Involved Immediate Action Taken Reported By
02/02/2025 Chemical Spill Solvent A Spill Contained, Area Evacuated Ajay Singh

Annexure-4: PPE Training Log

Date Training Topic Trainer Attendee Name Signature
03/02/2025 Proper Use of Respirators Health & Safety Officer Ravi Kumar

Annexure-5: Compliance Audit Log

Date Audit Type Findings Corrective Actions Taken Audited By
04/02/2025 PPE Compliance Improper Glove Use Re-training Conducted 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 Safety Equipment Use Procedures Regulatory Compliance QA Head
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