Gel Manufacturing: SOP for Cleaning and Disinfection of Gel Manufacturing Area – V 2.0

Standard Operating Procedure for Cleaning and Disinfection of Gel Manufacturing Area

Department	Gel Manufacturing
SOP No.	SOP/GM/143/2025
Supersedes	SOP/GM/143/2022
Page No.	Page 1 of 11
Issue Date	09/06/2025
Effective Date	11/06/2025
Review Date	09/06/2027

1. Purpose

To describe the procedure for the systematic cleaning and disinfection of the gel manufacturing area, ensuring maintenance of microbial control and compliance with cGMP standards.

2. Scope

This SOP applies to all classified and non-classified areas within the gel manufacturing unit including processing rooms, corridors, airlocks, and gowning areas.

3. Responsibilities

Housekeeping Staff: Perform daily cleaning and record activities.
Production Officer: Verify and supervise execution of cleaning schedule.
QA Executive: Conduct periodic verification and environmental monitoring to ensure effectiveness.

4. Accountability

Head – Production is accountable for maintaining cleanliness in

the manufacturing environment in compliance with regulatory requirements.

5. Procedure

5.1 Cleaning Frequency

Perform cleaning of Grade D areas once per shift or as per daily cleaning schedule.
Gowning and common areas to be cleaned twice daily or more frequently if required.
Perform weekly deep cleaning as per schedule and in presence of QA personnel.

5.2 Cleaning Agents and Disinfectants

Use approved cleaning agents like 2% non-ionic detergent.
Disinfectants to include 70% IPA, 0.2% sodium hypochlorite, and sporicidal agents on a rotational basis.
Ensure rotation of disinfectants every 30 days to prevent microbial resistance.

5.3 Cleaning Tools

Use lint-free mops, disinfectant-compatible buckets, and non-shedding wipes.
Designate separate cleaning equipment for different areas to avoid cross-contamination.

5.4 Cleaning Methodology

Pre-clean visible dirt using dry wipes before applying disinfectants.
Start from the cleanest area (Grade C) to the dirtiest (Grade D).
Use unidirectional wiping technique, avoiding back-and-forth motion.
Cover all surfaces including walls, floors, ceilings, doors, window panels, and equipment exteriors.

5.5 Documentation

Record each cleaning activity in the cleaning checklist – Annexure-1.
Document disinfectant lot number, concentration, and expiry.
Attach cleaning log sheets in the batch manufacturing records when applicable.

5.6 Handling Cleaning Deviations

In case of missed cleaning, document the deviation and notify QA.
Perform immediate cleaning and justify impact assessment on product quality.
Initiate CAPA if deviation exceeds allowable limit or is repeated.

6. Abbreviations

GMP: Good Manufacturing Practices
IPA: Isopropyl Alcohol
QA: Quality Assurance
CAPA: Corrective and Preventive Action

7. Documents

Cleaning Schedule – Annexure-1
Cleaning Log Sheet – Annexure-2
Disinfectant Rotation Record – Annexure-3
Deviation Report – Annexure-4

8. References

EU GMP Annex 1 – Manufacture of Sterile Medicinal Products
WHO TRS 961 – Cleaning and Disinfection Guidelines

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	Jr. Production Chemist	QA Executive	Head – Manufacturing
Department	Gel Manufacturing	Quality Assurance	Manufacturing

11. Annexures

Annexure-1: Cleaning Schedule Template

Area	Frequency	Responsible	QA Verification
Gel Mfg Room	Daily	Housekeeping	✔

Annexure-2: Cleaning Log Sheet

Date	Area	Cleaning Agent	Disinfectant	Done By	Verified By

Annexure-3: Disinfectant Rotation Record

Month	Disinfectant Used	Lot No.	Expiry	Prepared By

Annexure-4: Deviation Report Template

Deviation ID
Date Noted
Description
Immediate Action
CAPA Proposed
QA Remarks

Revision History

Revision Date	Revision No.	Change Description	Reason	Approved By
21/03/2022	1.0	Initial Release	New SOP	QA Head
09/06/2025	2.0	Added deviation handling, updated disinfectant rotation	Annual Review	QA Head