used in gel formulation manufacturing, including reactors, mixers, filling machines, transfer lines, and storage vessels.

3. Responsibilities

• Production Operator: Performs visual inspection and fills equipment verification checklist.
• QA Officer: Conducts verification of cleanliness status and signs off before equipment use.
• Engineering Department: Ensures equipment tags are up-to-date and free from maintenance-related contamination.

4. Accountability

Head – Manufacturing

5. Procedure

5.1 Visual Inspection

1. Check for absence of previous batch residues, product, or cleaning agent remnants.
2. Inspect internal and external surfaces, pipelines, valves, and agitators thoroughly under adequate illumination.
3. Ensure all accessories such as gaskets and seals are intact and clean.

5.2 Status Label Check

1. Verify that a “Cleaned” status label is affixed and signed by the responsible person from production and QA.
2. The label must indicate equipment name, ID, cleaning date/time, and signature of verifier.

5.3 Swab Test (if applicable)

1. If defined in the cleaning validation protocol, perform swab sampling from hard-to-clean surfaces.
2. Submit swabs to QC for microbial and chemical residue testing.
3. Proceed with equipment usage only after passing results are received and documented.

5.4 Documentation

1. Complete the Equipment Cleaning Verification Form (Annexure-1) before starting any manufacturing activity.
2. QA shall review and sign off the form before allowing batch processing to proceed.
3. Attach the verified form to the respective Batch Manufacturing Record (BMR).

5.5 Non-Conformance Handling

1. If any sign of uncleanliness or deviation is observed, segregate the equipment immediately.
2. Initiate a deviation report and notify QA for further investigation and corrective action.

6. Abbreviations

• BMR: Batch Manufacturing Record
• QA: Quality Assurance
• QC: Quality Control
• GMP: Good Manufacturing Practice

7. Documents

1. Equipment Cleaning Verification Form – Annexure-1
2. Swab Test Report – Annexure-2 (if applicable)
3. Equipment Logbook Entries

8. References

• WHO TRS 986 Annex 2 – GMP for Pharmaceutical Products
• 21 CFR Part 211 – Current Good Manufacturing Practice
• Schedule M – GMP 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: Equipment Cleaning Verification Form

Equipment Name
Equipment ID
Previous Batch No.
Date & Time of Cleaning
Cleanliness Verified By
QA Verification
Remarks

Annexure-2: Swab Test Report (Optional)

Equipment Name
Swab Location
Test Parameter
Result
QC Analyst
Remarks

Revision History

Revision Date	Revision No.	Change Description	Reason	Approved By
10/03/2022	1.0	Initial Issue	New SOP	QA Head
09/06/2025	2.0	Revised format and added swab verification steps	Regulatory update	QA Head