SOP Guide for Pharma

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

Auditor

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.
See also  Gel Manufacturing: SOP for Verification of Equipment Cleaning Before Use - V 2.0

5. Procedure

5.1 Cleaning Frequency

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

5.2 Cleaning Agents and Disinfectants

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

5.3 Cleaning Tools

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

5.4 Cleaning Methodology

  1. Pre-clean visible dirt using dry wipes before applying disinfectants.
  2. Start from the cleanest area (Grade C) to the dirtiest (Grade D).
  3. Use unidirectional wiping technique, avoiding back-and-forth motion.
  4. Cover all surfaces including walls, floors, ceilings, doors, window panels, and equipment exteriors.
See also  Gel Manufacturing: SOP for Screening Polymers for Gel Development - V 2.0

5.5 Documentation

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

5.6 Handling Cleaning Deviations

  1. In case of missed cleaning, document the deviation and notify QA.
  2. Perform immediate cleaning and justify impact assessment on product quality.
  3. 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

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

8. References

  • EU GMP Annex 1 – Manufacture of Sterile Medicinal Products
  • WHO TRS 961 – Cleaning and Disinfection Guidelines
See also  Process Validation Procedure for Gel Manufacturing - V 2.0

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
Exit mobile version