Standard Operating Procedure for Gowning Procedure for Upstream Suite in Biosimilar Manufacturing

Department	Biosimilars
SOP No.	SOP/BS/139/2025
Supersedes	SOP/BS/139/2022
Page No.	Page 1 of 9
Issue Date	04/05/2025
Effective Date	06/05/2025
Review Date	04/05/2026

1. Purpose

To establish a standardized gowning procedure for personnel accessing upstream manufacturing areas to minimize contamination risks and maintain aseptic and controlled conditions as per GMP guidelines.

2. Scope

This SOP applies to all production, QC, QA, engineering, and maintenance personnel entering the Grade C and Grade D upstream processing areas of the biosimilar manufacturing facility.

3. Responsibilities

• All Personnel: Follow gowning steps as per this SOP and report any gowning failures.
• QA: Monitor gowning adherence and conduct periodic gowning audits.
• Production Supervisor: Ensure gowning materials are available and properly stocked.

4. Accountability

The Manufacturing Head is accountable for enforcing the gowning protocol and ensuring that no person enters the upstream suite without proper gowning.

5. Procedure

5.1 Entry Criteria

1. Only trained personnel listed in the gowning qualification log (Annexure-1) shall enter cleanrooms.
2. Entry permitted only via designated change rooms with unidirectional flow (black → gray → white).

5.2 Stepwise Gowning Process (Grade D to Grade C)

1. Remove all street clothing and accessories in the outer change room.
2. Wear facility-provided:
   • Cleanroom underwear
   • Hair cover and beard cover
   • Plastic shoe covers
3. Perform hand wash with non-antimicrobial soap (≥20 seconds), dry with sterile towels.
4. Don cleanroom garments in the following order in the Grade D area:
   • Cleanroom overalls (coverall type)
   • Dedicated cleanroom clogs
   • Sterile gloves (inner)
5. Disinfect gloved hands using 70% IPA and move to Grade C area.
6. In Grade C:
   • Wear sterile outer gloves (without touching surfaces)
   • Wear sterile gown/coverall and hood (zip fully closed)
   • Wear sterile overshoes
   • Wear goggles and mask (if required)

5.3 Gown Removal

1. Remove gown in reverse order in the designated gown-out area.
2. Discard used disposable components in biohazard bins.
3. Reusable items like goggles to be sent for autoclaving and recorded in Annexure-2.

5.4 Gowning Failure and Retraining

1. Improper gowning must be logged as deviation and reported to QA.
2. Personnel must undergo retraining and gowning requalification before re-entry.

6. Abbreviations

• IPA: Isopropyl Alcohol
• GMP: Good Manufacturing Practice
• QA: Quality Assurance

7. Documents

1. Gowning Qualification Log – Annexure-1
2. Reusable Gowning Item Autoclave Log – Annexure-2

8. References

• EU GMP Annex 1 – Manufacture of Sterile Medicinal Products
• WHO TRS 961 – GMP for Biological Products

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 Qualification Log

Name	Department	Date Qualified	Trainer	Remarks
Ajay Verma	Production	02/05/2025	QA Officer	Qualified

Annexure-2: Reusable Gowning Item Autoclave Log

Item	ID	Date Sent	Autoclaved By	Returned Date
Goggles	G-108	03/05/2025	Sunita Reddy	04/05/2025

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
04/05/2025	2.0	Added retraining protocol and reusable item tracking	GMP Compliance Enhancement