Standard Operating Procedure for Handling Material Spillage in Dispensing Area

Department	Elixir Department
SOP No.	SOP/ELX/022/2025
Supersedes	SOP/ELX/022/2022
Page No.	Page 1 of 8
Issue Date	13/04/2025
Effective Date	15/04/2025
Review Date	13/04/2026

1. Purpose

To define a procedure for the safe and effective handling, containment, and disposal of raw material spillage in the dispensing area of the Elixir Department, ensuring safety of personnel and prevention of cross-contamination.

2. Scope

This SOP applies to all types of material spillage (API, excipients, solvents, etc.) occurring during weighing, transfer, or handling in the dispensing room.

3. Responsibilities

• Dispensing Operator:
  • Immediately inform the supervisor in case of spillage.
  • Secure the area and initiate containment.
• Warehouse Supervisor:
  • Evaluate the spill, ensure proper clean-up, and document the incident.
• QA Officer:
  • Verify the clean-up procedure and assess the impact on material integrity and area cleanliness.

4. Accountability

The Head of Warehouse and Head of QA are accountable for ensuring that all material spills are handled appropriately and that records are maintained for GMP compliance.

5. Procedure

5.1 Initial Response to Spillage

1. Stop all activities in the immediate area where the spill occurred.
2. Inform the Warehouse Supervisor and QA Officer immediately.
3. Place “SPILLAGE – DO NOT ENTER” signage to restrict area entry.

5.2 Assessment and Classification

1. Identify the material spilled (API, excipient, solvent, etc.).
2. Assess quantity, physical state (powder/liquid), and potential hazards (e.g., irritant, flammable).
3. Refer to the Safety Data Sheet (SDS) for specific handling precautions.

5.3 Containment and Cleaning

1. Wear appropriate PPE (gloves, mask, eye protection, apron).
2. For powders:
   • Cover the spill with wet lint-free cloth to prevent dust dispersal.
   • Scoop up the material using non-sparking tools and dispose in designated spill bin.
3. For liquids:
   • Use absorbent material to contain the spill (e.g., spill pads, sand, absorbent granules).
   • Wipe with lint-free cloth and clean with 70% IPA or appropriate neutralizer.
4. Do not flush chemical spills into drains unless confirmed safe.

5.4 Disposal of Spillage Waste

1. Place contaminated cleaning materials and PPE in spill disposal bags.
2. Label as “SPILLAGE WASTE – TO BE DISPOSED.”
3. Dispose as per SOP on hazardous/non-hazardous waste disposal.

5.5 Documentation

1. Record incident details in the Spillage Incident Log (Annexure-1).
2. Include:
   • Date and time of spillage
   • Material name and quantity
   • Cause of spillage
   • Corrective actions taken
3. Initiate deviation report if spill involves critical materials or repeated occurrence.

5.6 Area Clearance

1. After cleaning, QA performs visual inspection and swab sampling (if applicable).
2. Resume operations only after QA approval.

6. Abbreviations

• SOP: Standard Operating Procedure
• PPE: Personal Protective Equipment
• SDS: Safety Data Sheet
• QA: Quality Assurance

7. Documents

1. Spillage Incident Log (Annexure-1)
2. Deviation Form (if applicable)
3. Cleaning and Verification Record

8. References

• 21 CFR Part 211 – Subpart E: Control of Components
• WHO GMP Guidelines – Area and Equipment Hygiene

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Spillage Incident Log

Date	Time	Material Name	Quantity	Handled By	Cause	Corrective Action
13/04/2025	10:10 AM	Sodium Benzoate	100 g	Rajesh Kumar	Container Slip	Proper Handling Training

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
10/01/2022	1.0	Initial Release	New SOP	QA Head
13/04/2025	2.0	Expanded waste disposal and deviation clause	Audit Observation	QA Head