the Gel Manufacturing department.

3. Responsibilities

• Housekeeping Staff: Performs daily and scheduled cleaning as per cleaning schedule.
• Production Operator: Verifies cleaning activities before batch start.
• QA Executive: Performs random verification and environmental swabbing post-cleaning.
• Engineering: Ensures availability of utilities like vacuum, compressed air, and ventilation.

4. Accountability

Manager – Quality Assurance

5. Procedure

5.1 Types of Cleaning

• Routine Cleaning: Performed daily before and after production activities.
• Changeover Cleaning: Performed when changing product batches or between shifts.
• Deep Cleaning: Conducted weekly/monthly or during shutdown periods.

5.2 Cleaning Agents and Disinfectants

1. Use approved cleaning agents (e.g., non-ionic detergents) and disinfectants (e.g., IPA 70%, Quat-based agents).
2. Rotate disinfectants every 30 days to avoid resistance buildup.
3. Prepare disinfectant solutions fresh daily using purified water.

5.3 Cleaning Steps

1. Remove visible debris using dry wiping or vacuum cleaning.
2. Mop floors using 0.5% detergent solution followed by potable water rinse.
3. Disinfect all contact surfaces (walls, equipment exteriors, doors) using approved disinfectants.
4. Allow contact time as per manufacturer’s instructions (typically 10–15 minutes).
5. Use lint-free wipes and separate color-coded mops for different zones.

5.4 Cleaning Schedule

Refer to the Cleaning Frequency Matrix – Annexure-1. Activities include:

• Floors: Twice per shift
• Walls and Doors: Once daily
• Ceiling Vents: Once weekly
• Equipment Exteriors: Before and after use

5.5 Documentation

1. Record all cleaning activities in Cleaning Logbook – Annexure-2.
2. QA to sign off after verification.

5.6 Precautions

• Do not use strong oxidizing agents unless specifically approved.
• Avoid excessive moisture accumulation.
• Wear gloves, goggles, and face masks during disinfection.

6. Abbreviations

• IPA: Isopropyl Alcohol
• QA: Quality Assurance
• CFU: Colony Forming Units

7. Documents

1. Cleaning Frequency Matrix – Annexure-1
2. Cleaning and Disinfection Logbook – Annexure-2
3. Disinfectant Rotation Record – Annexure-3

8. References

• WHO GMP Guidelines for Pharmaceutical Manufacturing
• EU GMP Annex 1 – Manufacture of Sterile Medicinal Products
• FDA Guidance for Industry – Cleaning Validation

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 Frequency Matrix

Area	Cleaning Type	Frequency
Floor	Wet Mopping	Twice per shift
Walls	Wiping	Daily
Ceiling Vents	Dusting	Weekly
Equipment Exterior	Surface Disinfection	Pre/Post Operation

Annexure-2: Cleaning and Disinfection Logbook

Date	Area	Cleaning Done By	Checked By (Production)	Verified By (QA)

Annexure-3: Disinfectant Rotation Record

Date	Disinfectant Name	Batch No.	Prepared By	QA Verified

Revision History

Revision Date	Revision No.	Change Description	Reason	Approved By
21/05/2022	1.0	Initial issue	New SOP	QA Head
09/06/2025	2.0	Updated disinfectant rotation and documentation tables	Periodic review	QA Head