including mixing tanks, transfer pipelines, filling nozzles, and associated utensils used in production areas.

3. Responsibilities

• Production Operator: Ensures proper cleaning is performed and equipment is available for sampling.
• QA Executive: Conducts verification activities including visual inspection and sampling.
• QC Analyst: Performs laboratory analysis on collected swab and rinse samples.

4. Accountability

Head – Quality Assurance

5. Procedure

5.1 Visual Inspection

1. Inspect cleaned surfaces for residues, stains, and product traces using a white light torch and mirror.
2. Document inspection outcome in Visual Cleanliness Checklist – Annexure-1.

5.2 Swab Sampling

1. Identify worst-case locations such as corners, joints, or areas previously found to retain residue.
2. Use sterile cotton swabs moistened with appropriate solvent (e.g., water for injection).
3. Swab a defined surface area (e.g., 25 cm²) using a standard S-shape pattern.
4. Transfer swabs to labeled tubes and send to QC for analysis of residues (API and detergent).

5.3 Rinse Sampling

1. Fill the cleaned vessel with 100 mL–1000 mL of purified water depending on size.
2. Agitate and collect rinse samples into sterile bottles.
3. Send for TOC, conductivity, and residue analysis.

5.4 Acceptance Criteria

• Visual Inspection: No visible residue or stains.
• Swab Samples: Residue levels below defined limit (e.g., NMT 10 ppm for API).
• Rinse Samples: TOC below 500 ppb; Conductivity within purified water specs.

5.5 Re-cleaning Procedure

1. If any test fails, re-clean the equipment and repeat verification.
2. Record the re-cleaning event and test results in Cleaning Failure Log – Annexure-3.

5.6 Documentation and Reporting

1. Compile all inspection records, test results, and approvals in Cleaning Verification Report – Annexure-2.
2. Maintain all records in the QA documentation room for a period of 5 years.

6. Abbreviations

• TOC: Total Organic Carbon
• QA: Quality Assurance
• QC: Quality Control
• GMP: Good Manufacturing Practices

7. Documents

1. Visual Cleanliness Checklist – Annexure-1
2. Cleaning Verification Report – Annexure-2
3. Cleaning Failure Log – Annexure-3

8. References

• 21 CFR Part 211 – Current Good Manufacturing Practices
• ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
• WHO Technical Report Series No. 1010

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: Visual Cleanliness Checklist

Equipment ID
Surface Inspected
Observation	Clean / Unclean
Inspected By
Date

Annexure-2: Cleaning Verification Report

Equipment Name
Swab Sample Result (ppm)
Rinse Sample TOC (ppb)
Final Status	Pass / Fail
QA Approval

Annexure-3: Cleaning Failure Log

Date
Equipment ID
Failure Type	Visual / Swab / Rinse
Corrective Action Taken
Verified By

Revision History

Revision Date	Revision No.	Change Description	Reason	Approved By
12/07/2022	1.0	Initial issue	New SOP	QA Head
09/06/2025	2.0	Enhanced with rinse sampling and annexures	Regulatory requirement	QA Head