SOP Guide for Pharma

Elixir Department: SOP for Handling of Spillage During Dispensing – V 2.0

Auditor

Elixir Department: SOP for Handling of Spillage During Dispensing – V 2.0

Standard Operating Procedure for Handling of Spillage During Material Dispensing

Department Elixir Department
SOP No. SOP/ELX/045/2025
Supersedes SOP/ELX/045/2022
Page No. Page 1 of 8
Issue Date 11/04/2025
Effective Date 15/04/2025
Review Date 11/04/2026

1. Purpose

To define the procedure for handling any spillage of raw materials, excipients, or solvents during dispensing operations in the Elixir Department to ensure safety, minimize contamination, and comply with GMP practices.

2. Scope

This SOP is applicable to all personnel involved in dispensing of materials for elixir manufacturing and covers all types of spills (powders, liquids, solvents) within dispensing booths or controlled areas.

3. Responsibilities

  • Dispensing Operator:
    • Immediately report and initiate first response for any spill incident.
    • Clean minor spills using approved materials and PPE.
  • Supervisor:
    • Assess the spillage, classify the incident (minor/major), and coordinate cleanup.
    • Ensure appropriate documentation is maintained.
  • QA Officer:
    • Review and approve the cleanup procedure and determine material usability post-incident.
See also  Elixir Department: SOP for Handling Material Return Post Dispensing - V 2.0

4. Accountability

The Production Head and Safety Officer are accountable for ensuring adherence to this SOP and implementation of corrective measures after spillage.

5. Procedure

5.1 Classification of Spillage

  1. Minor Spillage: Small quantities that do not pose chemical hazards and can be cleaned by dispensing personnel.
  2. Major Spillage: Large volume spills, hazardous solvent spillage, or contamination risk requiring immediate supervisor and QA involvement.

5.2 General Precautions

  1. Ensure spill kits and PPE (gloves, mask, goggles) are available in the dispensing area.
  2. Place warning signage (“Spill Area – Do Not Enter”) around the affected zone.

5.3 Handling Minor Spillage

  1. Wear appropriate PPE before initiating cleanup.
  2. Collect powder spillage using a HEPA-filtered vacuum or wet lint-free wipes.
  3. For liquids/solvents, use absorbent pads or spill pillows to soak the material.
  4. Dispose of waste in designated yellow/red biohazard bags and label as “Spill Waste.”
  5. Clean the surface with 70% IPA or other approved disinfectant.
  6. Document the incident in the Spill Register (Annexure-1).
See also  Elixir Department: SOP for Use of Barcode Systems During Dispensing - V 2.0

5.4 Handling Major Spillage

  1. Immediately evacuate non-essential personnel and notify the area supervisor and QA.
  2. Isolate the area and switch off HVAC if flammable solvents are involved.
  3. Use chemical-resistant gloves, goggles, face shield, and respirator (if required).
  4. Clean as per validated SOP for hazardous chemical containment.
  5. Dispose contaminated items as per waste handling SOP.
  6. Fill Deviation Report (Annexure-2) and conduct root cause analysis if repeated.

5.5 Post-Cleanup Verification

  1. QA to inspect the area and confirm it is clean and safe for operation.
  2. Record the clearance status in the Spill Register and resume dispensing only after QA sign-off.

6. Abbreviations

  • SOP: Standard Operating Procedure
  • QA: Quality Assurance
  • PPE: Personal Protective Equipment
  • HEPA: High Efficiency Particulate Air

7. Documents

  1. Spill Register (Annexure-1)
  2. Deviation Report (Annexure-2)
  3. Post-Spillage Clearance Log (Annexure-3)

8. References

  • OSHA Guidelines for Chemical Spills
  • WHO GMP – Pharmaceutical Production Safety Practices
See also  Elixir Department: SOP for Sampling of Raw Materials for Elixirs - 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: Spill Register

Date Material Batch No. Type of Spill Cleaned By Verified By Remarks
11/04/2025 Sorbitol Solution SB2025 Minor – Liquid Rajesh Kumar Sunita Reddy Cleaned & Area Cleared

Annexure-2: Deviation Report

Date Material Batch No. Description Root Cause Corrective Action Approved By
11/04/2025 Sorbitol Solution SB2025 Spillage during container tilt Container not secured Clamp trays implemented QA Head

Annexure-3: Post-Spillage Clearance Log

Date Area Spill Type Cleared By Verified By (QA) Status
11/04/2025 Dispensing Booth 2 Minor Rajesh Kumar Sunita Reddy Ready for Use

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial Issue New SOP Creation QA Head
11/04/2025 2.0 Annexures Added; Classification Enhanced Audit Preparedness QA Head
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