SOP Guide for Pharma

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

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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.
See also  BA-BE Studies: SOP for Handling Inquiries from Regulatory Agencies - V 2.0

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

  1. Designated gowning rooms shall be provided at the entry of all controlled areas.
  2. Posters displaying gowning steps must be displayed visibly at gowning areas.
  3. 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

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

5.3 Gowning Steps

  1. Perform thorough hand washing using antiseptic soap for at least 20 seconds.
  2. Dry hands using disposable tissue/towel.
  3. Wear the following items in this sequence:
    • Shoe covers
    • Hair cover
    • Face mask
    • Disposable gown/lab coat
    • Latex/nitrile gloves (worn last)
  4. Replace gloves and mask every 4 hours or upon becoming moist or soiled.
See also  BA-BE Studies: SOP for Blinding and Unblinding Protocols in BA/BE Studies - V 2.0

5.4 Gown Removal and Disposal

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

5.5 Special Instructions for Sterile Sampling/Dosing Zones

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

5.6 Gowning Compliance Monitoring

  1. Annexure-1: Gowning Compliance Checklist must be filled daily by designated QA staff.
  2. Non-compliance shall be reported in Annexure-2: Gowning Deviation Report.
  3. 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
See also  BA-BE Studies: SOP for Sample Storage at -20°C and -70°C - V 2.0

7. Documents

  1. Gowning Compliance Checklist – Annexure-1
  2. 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
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