this SOP, reviews cleaning records, and approves the tanks for use in subsequent batches.

Maintenance Team: Responsible for ensuring that all cleaning equipment (e.g., cleaning in place (CIP) systems, hoses) is maintained and functional.

4. Accountability

The Head of Creams Manufacturing is responsible for ensuring that this SOP is followed correctly. The QA Manager is accountable for reviewing the cleaning process, verifying documentation, and approving the cleaned tanks for the next production cycle.

5. Procedure

5.1 Pre-Cleaning Preparation

1. Before cleaning, ensure that the manufacturing tank is empty, and all materials have been removed. Verify that no residual cream or ingredients remain in the tank.
2. Prepare all necessary cleaning agents (detergents, disinfectants, solvents) based on the material requirements of the tank and the type of cream produced.
3. Inspect all cleaning equipment (e.g., hoses, pumps, CIP systems) to ensure it is in good working condition. Make sure the cleaning equipment has been properly sanitized before use.
4. Review the cleaning logs from previous cycles to ensure no issues were reported, and ensure that the tank is free from any visible contamination.

5.2 Cleaning Process

1. For tanks equipped with Cleaning In Place (CIP) systems:
   • Start the CIP system according to the manufacturer’s instructions, ensuring that all parts of the tank, including the interior surfaces, nozzles, and hoses, are thoroughly cleaned.
   • Ensure the cleaning cycle includes proper flushing with water to remove all residues and followed by a detergent wash. Perform a final rinse with water to remove any detergent.
   • Verify that the CIP system is calibrated for the correct temperature, pressure, and flow rate to ensure effective cleaning.
2. For tanks that do not have CIP systems, manually clean the tank by first rinsing with water to remove visible residues, then applying an appropriate detergent and scrubbing the interior surfaces with clean brushes.
3. After the initial wash, rinse the tank thoroughly with clean water until no detergent residues remain.
4. Use disinfectant to sanitize the interior surfaces of the tank. Ensure that the disinfectant is compatible with the tank material and the cream formulation.
5. After the disinfection cycle, perform a final rinse to remove any traces of disinfectant.

5.3 Post-Cleaning Verification

1. Once the cleaning process is complete, perform a visual inspection of the tank to ensure that it is free from any residues, stains, or contaminants.
2. Conduct a swab test or use a cleaning verification kit to ensure that the tank is free from microbial contamination or cleaning agent residues. The swab test results must meet the specified acceptable limits for cleanliness.
3. Document the results of the cleaning verification, including the swab test results, in the Cleaning Log (Annexure-1).
4. If the tank fails any part of the verification process (e.g., if swab test results are unsatisfactory), repeat the cleaning process, addressing the identified issues (e.g., inadequate detergent concentration, insufficient cleaning time).

5.4 Documentation

1. Record all cleaning activities in the Cleaning Log, including:
   • Batch number
   • Cleaning agents used
   • Cleaning start and end times
   • Inspection and test results
   • Any deviations or issues encountered
2. All cleaning records must be signed by the responsible operator and reviewed by the QA team.
3. Store cleaning records in the designated database or filing system for easy retrieval during audits and inspections.

5.5 Handling Deviations

1. If a deviation occurs during the cleaning process (e.g., improper cleaning due to equipment malfunction or human error), document the deviation in the Deviation Report Form (Annexure-2).
2. Investigate the cause of the deviation, implement corrective actions, and ensure that the tank is re-cleaned and re-verified before it is used for the next batch of cream.
3. Maintain a record of the deviation, corrective actions taken, and preventive measures to prevent recurrence in the future.

5.6 Final Approval and Use

1. Once the cleaning is completed and all verification steps have passed, the QA team must approve the tank for use in the next batch of cream manufacturing.
2. Ensure that the tank is properly labeled with the date and time of cleaning, and any other relevant information (e.g., batch number, cleaning status) to ensure traceability.

6. Abbreviations

• QC: Quality Control
• QA: Quality Assurance
• CIP: Cleaning In Place
• GMP: Good Manufacturing Practices

7. Documents

1. Cleaning Log (Annexure-1)
2. Deviation Report Form (Annexure-2)
3. Cleaning Verification Report (Annexure-3)

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 Cosmetics Manufacturing

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

Batch Number	Cleaning Start Time	Cleaning End Time	Operator	Cleaning Verification
12345	08:00 AM	09:00 AM	Jane Smith	Pass

Annexure-2: Deviation Report Form

Deviation Description	Time	Batch Number	Operator	Immediate Action
Cleaning error	08:45 AM	12345	John Doe	Re-clean tank

Annexure-3: Cleaning Verification Report

Batch Number	Verification Method	Result	Corrective Action
12345	Swab Test	Pass	None

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