BA-BE Studies: SOP for Gowning Procedures for Clinical Staff – V 2.0

Standard Operating Procedure for Gowning Procedures for Clinical Staff in BA/BE Studies

Department	BA-BE Studies
SOP No.	SOP/BA-BE/131/2025
Supersedes	SOP/BA-BE/131/2022
Page No.	Page 1 of 8
Issue Date	17/04/2025
Effective Date	20/04/2025
Review Date	17/04/2026

1. Purpose

To establish uniform gowning procedures for all clinical staff entering controlled and semi-controlled areas during the conduct of BA/BE studies to minimize contamination risk and maintain hygiene standards as per regulatory requirements.

2. Scope

This SOP is applicable to all clinical, laboratory, nursing, and ancillary staff involved in the conduct of bioavailability/bioequivalence studies who enter dosing, sampling,

and volunteer housing areas within the clinical facility.

3. Responsibilities

Clinical Operations Manager: Ensures gowning procedures are implemented and followed by all staff.
QA Officer: Audits gowning compliance and maintains training records.
Study Coordinator: Monitors entry to restricted zones and ensures gowning supplies are available.
All Staff: Adhere strictly to the gowning requirements specified in this SOP.

4. Accountability

The Head of Clinical Department is accountable for ensuring adherence to gowning procedures and hygiene control in the clinical facility conducting BA/BE studies.

5. Procedure

5.1 Gowning Area Requirements

Designated gowning rooms shall be provided at the entry of all controlled areas.
Posters displaying gowning steps must be displayed visibly at gowning areas.
Each gowning area must have:
- Handwashing station with antiseptic soap and tissues
- Disposable gowns, gloves, shoe covers, face masks, hair covers
- Waste bin for disposal of used PPE

5.2 Personal Hygiene Requirements

Staff must ensure:
- Short and clean fingernails
- No open wounds or visible illness
- No strong perfumes, jewelry, or wrist accessories

5.3 Gowning Steps

Perform thorough hand washing using antiseptic soap for at least 20 seconds.
Dry hands using disposable tissue/towel.
Wear the following items in this sequence:
- Shoe covers
- Hair cover
- Face mask
- Disposable gown/lab coat
- Latex/nitrile gloves (worn last)
Replace gloves and mask every 4 hours or upon becoming moist or soiled.

5.4 Gown Removal and Disposal

Remove gloves first, then gown, followed by mask, shoe covers, and hair cover.
Dispose of used items in designated color-coded biomedical waste bins.
Perform hand hygiene after removing all PPE.

5.5 Special Instructions for Sterile Sampling/Dosing Zones

Use sterile disposable gowns and gloves prior to:
- Blood sampling
- Dosing administration
Double gloving is mandatory in sterile zones.

5.6 Gowning Compliance Monitoring

Annexure-1: Gowning Compliance Checklist must be filled daily by designated QA staff.
Non-compliance shall be reported in Annexure-2: Gowning Deviation Report.
Corrective training shall be provided within 48 hours of deviation.

6. Abbreviations

BA: Bioavailability
BE: Bioequivalence
QA: Quality Assurance
PPE: Personal Protective Equipment
CRF: Case Report Form

7. Documents

Gowning Compliance Checklist – Annexure-1
Gowning Deviation Report – Annexure-2

8. References

WHO Infection Prevention and Control Guidelines
ICH E6(R2) – Good Clinical Practice
CDC Guidelines on Healthcare Worker PPE

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Gowning Compliance Checklist

Date	Staff Name	Area	Gowning Complete	Remarks
16/04/2025	Rajesh Kumar	Sampling Room	Yes	Compliant

Annexure-2: Gowning Deviation Report

Date	Staff Name	Deviation	Corrective Action	Reviewed By
16/04/2025	Ajay Verma	No face mask worn	Immediate retraining	QA Officer

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
05/01/2022	1.0	Initial SOP release	GCP Compliance	QA Head
17/04/2025	2.0	Included gown removal and deviation handling process	Internal Audit Observation	QA Head