used again for production.

4. Accountability

The Head of Production is accountable for ensuring that packaging lines are cleaned regularly and according to the SOP. The QA Manager is responsible for reviewing cleaning records, inspecting the lines, and confirming cleanliness before production resumes.

5. Procedure

5.1 Pre-Cleaning Checks

1. Ensure that the production has ended, and all cream-filled containers are removed from the packaging line.
2. Turn off and disconnect all electrical and mechanical systems of the packaging machines to ensure safety during cleaning.
3. Remove any remaining packaging materials (e.g., labels, caps, containers) from the line and discard them in the appropriate waste bins.
4. Ensure that cleaning tools (e.g., brushes, cloths, cleaning agents) and personal protective equipment (PPE) are available for cleaning staff.

5.2 Cleaning Procedure

1. Start by cleaning all surfaces that come into contact with the cream, including filling nozzles, conveyor belts, and capping machines, using appropriate cleaning solutions.
2. Use a degreasing detergent to remove cream or oil residue from the equipment. Apply the detergent using brushes or cloths to scrub all surfaces thoroughly.
3. Clean the conveyor belts, checking for any cream buildup or residue that might remain on the belts or inside the machine parts.
4. Rinse all cleaned surfaces with water to remove detergent residues. Ensure that water does not accumulate on the equipment or cause any contamination risk.
5. Apply a sanitizing agent to the cleaned surfaces, ensuring that it is safe for use on food-contact surfaces. Follow the manufacturer’s instructions for proper dilution and contact time.

5.3 Drying and Inspection

1. Allow the equipment to air dry after cleaning. Ensure that all surfaces are completely dry before reassembling the packaging line.
2. Inspect the cleaned equipment to verify that no product residue or cleaning agents remain. Perform a visual inspection for any areas that might need additional cleaning.
3. If any issues are identified during the inspection (e.g., missed areas, excess cleaning agent), re-clean those sections before proceeding.

5.4 Reassembly and Setup

1. Once the equipment is dry and clean, reassemble any parts that were disassembled during the cleaning process, such as filling nozzles or capping units.
2. Check all machine settings and ensure that the filling machine, labeling machine, and other equipment are set up correctly for the next production run.
3. Ensure that any parts that were removed (e.g., parts for maintenance) are properly reinstalled and secure before starting the line again.

5.5 Post-Cleaning Verification

1. Once the cleaning is completed, the QC team should perform a final inspection of the equipment to ensure cleanliness and verify that no product residues are left behind.
2. Perform a swab test or rinse water test to check for residual contamination. If the test is positive, repeat the cleaning procedure until the equipment passes the cleanliness verification.
3. Document the results of the cleaning and verification, including the time taken, equipment cleaned, and any discrepancies encountered, in the Cleaning Log (Annexure-1).

5.6 Documentation

1. Record the cleaning activities in the Cleaning Log (Annexure-1), including the equipment cleaned, cleaning agents used, and inspection results.
2. Document any corrective actions taken during cleaning, such as additional cleaning or reassembly, in the Cleaning Log.

5.7 Final Approval

1. The QA team must review the cleaning records and verify that all necessary cleaning steps have been completed before the equipment is used for the next production run.
2. If any discrepancies are noted, corrective actions should be taken before production begins again.

6. Abbreviations

• GMP: Good Manufacturing Practices
• QC: Quality Control
• QA: Quality Assurance
• PPE: Personal Protective Equipment

7. Documents

1. Annexure-1: Cleaning Log

8. References

• Good Manufacturing Practices (GMP) Guidelines – 21 CFR Part 211
• International Conference on Harmonisation (ICH) Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
• FDA Guidelines for Equipment Cleaning and Sanitization

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Cleaning Log

Equipment ID	Cleaning Date	Cleaning Agents Used	Operator	Inspection Results
PF-001	21/01/2026	Detergent, Sanitizer	John Doe	Clean, no residues found

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/03/2024	1.0	Initial Version	New SOP Creation	QA Head
01/03/2025	2.0	Format Revision and Updates	Standardization of Document	QA Head