Elixir Department: SOP for Entry and Exit Procedure for Dispensing Area – V 2.0

Standard Operating Procedure for Entry and Exit Procedure for Dispensing Area

Department	Elixir Department
SOP No.	SOP/ELX/021/2025
Supersedes	SOP/ELX/021/2022
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 a controlled and hygienic entry and exit procedure for personnel entering and exiting the dispensing area of the Elixir Department, thereby minimizing the risk of contamination.

2. Scope

This SOP applies to all personnel including operators, QA, maintenance, and housekeeping staff entering or exiting the dispensing room used for raw material handling in elixir manufacturing.

3. Responsibilities

Dispensing Personnel:
- Comply strictly with gowning and hygiene protocols.
- Ensure proper use of change rooms.
Warehouse Supervisor:
- Verify entry/exit logs and ensure area discipline.
QA Officer:
- Perform periodic audit of entry/exit practices and gowning area cleanliness.

4. Accountability

The Head of Warehouse and Head of QA are accountable for ensuring adherence to entry and exit protocols in the dispensing area.

5. Procedure

5.1 Entry Procedure

Enter through the designated personnel entry

point and record your name, time, and purpose in the Entry Logbook (Annexure-1).

Remove personal accessories like wristwatches, rings, and mobile phones before entering the change room.

In the first change room (outer change area):

Remove street footwear and wear factory-provided slippers.
Wear disposable headgear and face mask.

Enter the second change room (clean change area):

Change into designated dispensing gown, apron, gloves, and shoe covers.
Ensure gown is fully buttoned/fastened and gloves are properly tucked in.
Use alcohol-based hand sanitizer before wearing gloves.

Check appearance in the mirror to verify correct gowning.

Step into the dispensing room through the airlock or air shower (if applicable).

5.2 Exit Procedure

Before exiting the dispensing area:
- Dispose of used gloves and masks in the designated biohazard bins.
- Remove outer gown and shoe covers and deposit in the designated used-garment bin.
Pass through the same airlock in reverse direction.
In the change room:
- Remove headgear and face mask.
- Change to personal clothing and street footwear.
- Wash hands thoroughly with soap and water before leaving the area.
Record exit time in the Exit Logbook.

5.3 Gowning Material Requirements

Disposable Head Cover
Face Mask (3-ply or N95 as applicable)
Non-shedding Gown
Latex/Nitrile Gloves
Shoe Covers

5.4 Restrictions and Discipline

Do not carry any loose papers, pens, or personal items into the dispensing room.
Smoking, eating, chewing, and use of mobile phones are strictly prohibited.
Unauthorized entry is not permitted.

6. Abbreviations

SOP: Standard Operating Procedure
QA: Quality Assurance

7. Documents

Personnel Entry/Exit Logbook (Annexure-1)
Gowning Checklist (Annexure-2)

8. References

WHO GMP Guidelines – Section on Personnel Hygiene
21 CFR Part 211 – Subpart C: Buildings and Facilities

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Personnel Entry/Exit Logbook

Date	Name	Time In	Time Out	Purpose	Signature
13/04/2025	Rajesh Kumar	08:45	10:15	API Dispensing	Rajesh

Annexure-2: Gowning Checklist

Item	Worn (Yes/No)	Checked By	Remarks
Head Cover	Yes	Sunita Reddy	OK
Face Mask	Yes	Sunita Reddy	OK
Gown	Yes	Sunita Reddy	OK
Gloves	Yes	Sunita Reddy	OK
Shoe Covers	Yes	Sunita Reddy	OK

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
10/01/2022	1.0	Initial SOP	New Document	QA Head
13/04/2025	2.0	Added annexures and clarified gowning steps	Audit Compliance	QA Head