Standard Operating Procedure for Use of Personal Protective Equipment (PPE) in Dispensing Room

Department	Elixir Department
SOP No.	SOP/ELX/010/2025
Supersedes	SOP/ELX/010/2022
Page No.	Page 1 of 8
Issue Date	13/04/2025
Effective Date	15/04/2025
Review Date	13/04/2026

1. Purpose

To establish standard requirements and procedures for the appropriate selection, usage, and disposal of personal protective equipment (PPE) by all personnel entering and working in the dispensing room of the Elixir Department.

2. Scope

This SOP applies to all employees, including permanent, temporary, and contract staff, involved in raw material dispensing activities for elixir manufacturing within the designated dispensing area.

3. Responsibilities

• All Dispensing Personnel:
  • Wear complete PPE before entering the dispensing room.
  • Follow gowning procedure as per training.
• Warehouse Supervisor:
  • Ensure availability and condition of PPE supplies.
• Quality Assurance (QA):
  • Conduct audits to verify compliance with PPE usage.

4. Accountability

The Head of Production and the Head of Quality Assurance are jointly accountable for enforcement and monitoring of PPE compliance in the dispensing room.

5. Procedure

5.1 PPE Requirements

1. The following PPE must be worn before entering the dispensing area:
   • Cleanroom coverall (non-shedding, full body)
   • Head cap
   • Face mask (surgical or N95, depending on sensitivity)
   • Sterile gloves (powder-free)
   • Shoe covers
   • Protective goggles (for handling potent or hazardous materials)
2. Use disposable PPE wherever applicable; discard after each shift or when soiled.

5.2 Gowning Procedure

1. Enter the change room adjacent to the dispensing room.
2. Wear garments in the following order:
   • Head cap
   • Face mask
   • Coverall suit
   • Shoe covers
   • Gloves
   • Goggles
3. Inspect PPE for damage or contamination before use.
4. Sanitize gloved hands using 70% IPA before entry.

5.3 Rules While Wearing PPE

1. Do not touch face or mask once PPE is worn.
2. Do not carry mobile phones, notebooks, or personal items inside the dispensing area.
3. Immediately replace PPE if it becomes torn, wet, or contaminated.

5.4 Exit Procedure

1. On completing dispensing activities:
   • Remove PPE in reverse order in the exit change room.
   • Discard disposable items in designated biohazard bins.
   • Place reusable PPE (if any) in the soiled garment bin for laundering.
2. Sanitize hands and sign the PPE Usage Log (Annexure-1).

5.5 Training and Compliance

1. All personnel must be trained on gowning procedure annually.
2. Gowning procedure posters should be displayed at entry points.
3. QA shall periodically verify PPE compliance and record observations.

6. Abbreviations

• SOP: Standard Operating Procedure
• PPE: Personal Protective Equipment
• IPA: Isopropyl Alcohol
• QA: Quality Assurance

7. Documents

1. PPE Usage Log (Annexure-1)
2. Training Record for PPE

8. References

• WHO GMP Guidelines – Personal Hygiene and Protective Equipment
• 21 CFR Part 211 – Subpart E: Control of Components and Drug Product Containers

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 Usage Log

Date	Employee Name	PPE Worn	Time In	Time Out	Remarks
13/04/2025	Rajesh Kumar	Coverall, Mask, Gloves, Goggles	09:15	11:30	—

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
10/01/2022	1.0	Initial Version	New SOP	QA Head
13/04/2025	2.0	Added exit procedure and reusable PPE control	Regulatory Compliance	QA Head