the manufacture of gel formulations that require cleaning validation in accordance with GMP, ICH, and regulatory requirements.

3. Responsibilities

• Production Staff: Perform cleaning as per SOP and record activities.
• QA Analyst: Conduct swab/rinse sampling and analytical testing.
• Validation Officer: Plan and execute validation batches, document reports.
• QA Head: Review and approve cleaning validation protocols and reports.

4. Accountability

Head – Quality Assurance and Head – Manufacturing

5. Procedure

5.1 Preparation of Cleaning Validation Protocol

1. Identify product with worst-case scenario (e.g., highest toxicity, lowest solubility).
2. Define acceptance criteria: NMT 10 ppm carryover, visual cleanliness, NMT 0.1% residue of previous product.
3. Specify sampling plan, analytical method, limits, and equipment to be validated.

5.2 Execution of Cleaning Procedure

1. Clean mixing vessels as per the approved cleaning SOP for the product.
2. Ensure visual cleanliness and log activity in the Equipment Cleaning Logbook.

5.3 Sampling and Testing

1. Conduct swab sampling from hard-to-clean areas (e.g., agitator blade, manhole, discharge valve).
2. Use validated methods (HPLC/UV) for detection of residue or cleaning agent.
3. Record data in Annexure-1 (Swab Sample Result Sheet).

5.4 Acceptance Criteria

• No visible residue on equipment surface.
• Residue levels below calculated MACO (Maximum Allowable Carry Over).
• Microbial count within limits (NMT 100 CFU/cm²).

5.5 Validation Report

1. Compile results, deviations, and conclusions in a validation summary report.
2. Attach all raw data, chromatograms, and calibration certificates.
3. QA Head to review and approve the report.

5.6 Revalidation Criteria

• Change in product formulation or cleaning method.
• Failure of routine cleaning verification.
• Major equipment maintenance or modifications.

6. Abbreviations

• MACO: Maximum Allowable Carry Over
• CFU: Colony Forming Units
• QA: Quality Assurance
• HPLC: High Performance Liquid Chromatography

7. Documents

1. Cleaning Validation Protocol
2. Swab/Rinse Sampling Form – Annexure-1
3. Validation Summary Report

8. References

• ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
• WHO TRS 986 Annex 7 – Cleaning Validation Guidelines
• Schedule M – Equipment Cleaning Validation Requirements

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: Swab Sample Result Sheet

Location	Sample ID	Surface Area (cm²)	Residue Detected (ppm)	Acceptance Limit (ppm)	Result
Agitator Blade				10
Manhole Rim				10
Outlet Valve				10

Revision History

Revision Date	Revision No.	Change Description	Reason	Approved By
20/04/2022	1.0	Initial release	New SOP	QA Head
09/06/2025	2.0	Revised validation criteria and updated sampling points	Annual Review	QA Head