at the facility.

3. Responsibilities

• Production Operator: Performs cleaning as per approved method.
• QA Executive: Verifies cleanliness and approves equipment for reuse.
• Maintenance Personnel: Assists in dismantling and reassembling as required.

4. Accountability

Head – Manufacturing

5. Procedure

5.1 Cleaning Types

• Batch-to-Batch Cleaning: For same product, similar strength.
• Product-to-Product Cleaning: Required when changing product or strength.
• Periodic Cleaning: Weekly or after extended equipment idling.

5.2 Cleaning Agents

1. Use purified water, 2% non-ionic detergent, and 70% IPA as applicable.
2. Ensure all cleaning agents are approved and within expiry.

5.3 Cleaning Process

1. Disconnect all accessories and dismantle detachable parts.
2. Rinse vessels and parts with lukewarm purified water to remove residues.
3. Apply 2% detergent solution and scrub using nylon brushes.
4. Rinse thoroughly with purified water until no foam remains.
5. Perform a final rinse with purified water and allow to drain completely.
6. Spray 70% IPA on surface contact areas and allow to air dry.
7. Reassemble all parts after verification of dryness.

5.4 Cleaning of Accessories

1. Clean sampling tools, spatulas, and pipe connectors as per steps in section 5.3.
2. Use designated cleaning area for small parts to avoid cross-contamination.

5.5 Post-Cleaning Checks

1. Inspect equipment visually for cleanliness.
2. Record cleaning activity in the Equipment Logbook.
3. QA to perform swab test (if required) and release for next use.

5.6 Documentation

1. Fill Cleaning Record – Annexure-1 after each cleaning activity.
2. Attach checklist and QA clearance – Annexure-2.

6. Abbreviations

• IPA: Isopropyl Alcohol
• QA: Quality Assurance
• SOP: Standard Operating Procedure

7. Documents

1. Cleaning Record – Annexure-1
2. QA Clearance Checklist – Annexure-2
3. Detergent Certificate of Analysis

8. References

• WHO TRS 986 Annex 2: GMP for Pharmaceutical Products
• 21 CFR Part 211 – US FDA CGMP Guidelines
• ICH Q7: GMP for Active Pharmaceutical Ingredients

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: Equipment Cleaning Record

Equipment Name
Equipment ID
Product
Cleaning Type	Batch-to-Batch / Product Change
Date of Cleaning
Cleaned By
Verified By (QA)

Annexure-2: QA Clearance Checklist

Checklist Item	Status (Yes/No)	Remarks
No visible residue
Swab test results (if applicable)
Dryness verified
Ready for next use

Revision History

Revision Date	Revision No.	Change Description	Reason	Approved By
20/06/2022	1.0	Initial release	New SOP	QA Head
09/06/2025	2.0	Revised cleaning steps, added annexures	GMP update	QA Head