Department, including mixing vessels, transfer lines, and packaging equipment.

3. Responsibilities

• Production Operator: Ensures visual cleanliness and initiates cleaning verification request.
• Quality Assurance Officer: Performs verification and authorizes equipment use.
• Manufacturing Supervisor: Coordinates the cleaning process and ensures adherence to SOP.

4. Accountability

Head – Quality Assurance and Head – Manufacturing

5. Procedure

5.1 Visual Inspection by Operator

1. Inspect equipment for visible residues, stains, or foreign particles.
2. Check hard-to-reach areas such as gaskets, nozzles, and agitator shafts.
3. Complete operator checklist and notify QA for verification.

5.2 Quality Assurance Verification

1. QA personnel to conduct independent visual inspection under adequate lighting.
2. Perform swab sampling from product contact surfaces for microbiological and chemical residue testing (if applicable).
3. Review last product manufactured and ensure compatibility or requirement of product changeover cleaning.

5.3 Documentation of Verification

1. Complete the Equipment Cleaning Verification Form – Annexure-1.
2. Record observations, swab results (if any), date, and authorization for use.
3. Attach the verification form with the batch production record (BPR).

5.4 Handling Non-Compliant Equipment

1. If cleaning is inadequate, mark equipment as “Not Cleaned” and return for re-cleaning.
2. Document deviation and investigate the cause if repeated failures occur.

5.5 Re-Use Time Limits

1. If the equipment remains unused for more than 72 hours after verification, re-verification is mandatory before use.

6. Abbreviations

• BPR: Batch Production Record
• QA: Quality Assurance
• SOP: Standard Operating Procedure

7. Documents

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

8. References

• WHO TRS 986 Annex 2 – Cleaning Validation
• Schedule M – Good Manufacturing Practices
• 21 CFR Part 211 – cGMP for Finished Pharmaceuticals

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
Cleaning Type	Product Changeover / Campaign
Last Product Manufactured
Visual Inspection Date
Swab Test Conducted	Yes / No
Swab Test Result	Pass / Fail
Verified By (QA)
Date of Verification
Status	Authorized for Use / Re-cleaning Required

Revision History

Revision Date	Revision No.	Change Description	Reason	Approved By
05/06/2022	1.0	Initial Issue	New SOP	QA Head
09/06/2025	2.0	Included swab sampling and re-verification time limits	Annual Review	QA Head