that cleaning validation and documentation comply with regulatory standards and guidelines.

4. Accountability

The QA Manager is accountable for ensuring that cleaning validation is performed in compliance with GMP guidelines and regulatory standards. The Production Manager ensures that all cleaning procedures are followed, and the QC Manager verifies the cleanliness of the equipment and production areas.

5. Procedure

5.1 Cleaning Procedure

1. The production team will carry out cleaning procedures based on the approved cleaning protocols. These protocols should specify:
   • The cleaning agents to be used
   • The equipment or production area to be cleaned
   • The cleaning method (manual or automated)
   • The cleaning parameters (e.g., time, temperature, concentration)
   • Rinsing and drying procedures
2. Once the cleaning procedure is completed, the equipment or production area will be inspected to ensure it is visually clean and free from residues.

5.2 Sampling for Cleaning Validation

1. After cleaning, the QC team will take samples from the cleaned equipment or production area to verify that cleaning was effective.
2. Sampling methods may include:
   • Swab sampling of surfaces
   • Rinse sampling
   • Environmental monitoring for microbial contamination
3. All samples should be properly labeled with details such as the date, equipment or area sampled, and the sampling method.

5.3 Cleaning Validation Testing

1. The QC team will test the samples collected for the presence of product residues, cleaning agents, or microbial contamination.
2. Testing methods may include:
   • High-performance liquid chromatography (HPLC) for residue analysis
   • Visual inspection for residue or discoloration
   • Microbial testing using petri dishes or swabs
3. If any residue or contamination is found above acceptable limits, the cleaning process will be considered invalid, and corrective actions must be taken.

5.4 Review of Cleaning Validation Report

1. Once the testing is complete, the QC team will prepare a cleaning validation report, which will include:
   • Details of the equipment or area cleaned
   • Cleaning procedures followed
   • Sample collection methods and results
   • Test results for residues, contaminants, and microbial testing
   • Any deviations or issues encountered during the cleaning validation process
2. The report will be submitted to the QA team for review and approval. The QA team will verify that all the cleaning parameters have been met and that the equipment or area is suitable for use in production.

5.5 Documentation and Record-Keeping

1. All cleaning validation activities, including sampling, testing, and the final report, must be thoroughly documented and retained for future reference.
2. The cleaning validation report should be reviewed by the QA team and signed off to confirm that the cleaning was validated successfully.
3. All records should be stored securely in accordance with GMP guidelines and regulatory requirements, and should be retrievable for audits or inspections.

5.6 Requalification of Cleaning Procedures

1. Cleaning validation may need to be re-qualified if:
   • There are changes to the production process, equipment, or materials
   • There is a new regulatory requirement
   • Any deviations or failures occur during routine cleaning
2. The QA team will initiate a new cleaning validation process as necessary and ensure that all changes are documented.

6. Abbreviations

• GMP: Good Manufacturing Practices
• QA: Quality Assurance
• QC: Quality Control
• SOP: Standard Operating Procedure
• HPLC: High-performance liquid chromatography

7. Documents

1. Annexure-1: Non-Conformance Report for Cleaning Validation
2. Annexure-2: Cleaning Validation Report Template
3. Annexure-3: Corrective Action Plan for Cleaning Failure

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 Guidance for Industry: Cleaning Validation

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Non-Conformance Report for Cleaning Validation

Issue Description	Product Affected	Batch Number	Detected By	Date Detected
Residue found after cleaning	Vanilla Cream	Batch 12345	QC Inspector	21/01/2026

Annexure-2: Cleaning Validation Report Template

Equipment/Area	Cleaning Procedure	Sampling Method	Test Results	Remarks
Mixing Tank	Manual cleaning with detergent solution	Swab sample	Pass	No residue detected

Annexure-3: Corrective Action Plan for Cleaning Failure

Corrective Action	Preventive Action	Responsible Person	Implementation Date
Repeat cleaning procedure with increased detergent concentration	Revise cleaning procedure based on findings	Production Manager	28/01/2026

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