is accountable for ensuring that cleaning validation protocols are reviewed and approved according to regulatory and internal standards. The Cleaning Validation Team is responsible for preparing and reviewing the protocols.

5. Procedure

5.1 Cleaning Protocol Development

1. Develop cleaning validation protocols based on the type of equipment, the nature of the products manufactured, and any potential cross-contamination risks.
2. Ensure that the protocols address critical cleaning parameters, including the cleaning agents used, cleaning methods, and validation testing procedures (Annexure-1).
3. The cleaning protocol must define the acceptance criteria for the cleanliness of equipment, including limits for residues, visual inspection, and microbial contamination.

5.2 Review of Cleaning Validation Protocols

1. QA must review cleaning validation protocols to ensure that they meet all regulatory requirements and internal standards for equipment cleanliness.
2. Ensure that the protocols include detailed procedures for sampling, testing, and documenting cleaning activities, as well as clear acceptance criteria for cleanliness (Annexure-2).
3. Review the choice of cleaning agents and methods to ensure they are appropriate for the equipment and manufacturing processes.
4. Ensure that the cleaning procedures are validated for their ability to remove residues and contaminants effectively, including substances from previous batches and cleaning agents themselves.

5.3 Validation of Cleaning Procedures

1. Review the results of the cleaning validation study to ensure that the cleaning procedures have been validated under realistic manufacturing conditions.
2. The cleaning validation study must include tests such as swab sampling for residues, rinse sampling for contaminants, and visual inspection for cleanliness (Annexure-3).
3. Verify that the cleaning methods are capable of achieving the required level of cleanliness for the equipment after each cleaning cycle.
4. Ensure that the validation study includes multiple runs to confirm the consistency of the cleaning process over time and across different equipment.

5.4 Approval of Cleaning Validation Protocols

1. Once the cleaning validation protocol and study results have been reviewed and deemed acceptable, QA must approve the cleaning validation protocol for implementation in the manufacturing process (Annexure-4).
2. Ensure that the approval includes an assessment of whether the cleaning protocol meets all relevant GMP and regulatory requirements for equipment cleanliness.
3. Document all approvals and sign-offs, ensuring that the protocol is fully traceable for future audits and inspections.

5.5 Review of Ongoing Cleaning Validation

1. Periodically review the cleaning validation protocols to ensure that they remain effective, particularly when there are changes in the manufacturing process or the type of products being produced.
2. Ensure that any new equipment or changes to existing equipment are incorporated into the cleaning validation process, and that new validation protocols are developed as necessary (Annexure-5).
3. Monitor cleaning performance over time through routine inspections and sampling to ensure that the cleaning process remains consistent and effective.

5.6 Documentation and Record Keeping

1. Ensure that all cleaning validation protocols, reports, and approval documents are retained in a secure, organized, and easily accessible manner for the required retention period (Annexure-6).
2. Maintain records of cleaning validations, including results from cleaning efficacy tests, and corrective actions taken if cleaning failures are identified.
3. Ensure that all cleaning validation documentation is available for internal audits, regulatory inspections, and quality reviews.

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• GMP: Good Manufacturing Practice
• CAPA: Corrective and Preventive Action
• IPQC: In-Process Quality Control

7. Documents

1. Cleaning Validation Protocol (Annexure-1)
2. Cleaning Validation Results (Annexure-2)
3. Validation Study Report (Annexure-3)
4. Approval Documents (Annexure-4)
5. Review Log (Annexure-5)
6. Cleaning Validation Records (Annexure-6)

8. References

• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
• ISO 9001 – Quality Management Systems
• ICH Q7 – Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

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 Validation Protocol

Equipment	Cleaning Procedure	Validation Method	Acceptance Criteria
Tablet Press	Manual Cleaning	Swab Sampling	Residue < 10 ppm

Annexure-2: Cleaning Validation Results

Batch Number	Inspection Results	Cleaning Method	Compliance Status
Batch-12345	Pass	Manual Cleaning	Compliant

Annexure-3: Validation Study Report

Test	Sample ID	Result	Conclusion
Swab Test	Sample-01	Residue 8 ppm	Pass

Annexure-4: Approval Documents

Protocol ID	Approval Status	Approved By	Approval Date
CVP-001	Approved	John Doe	01/04/2026

Annexure-5: Review Log

Review Date	Reviewed By	Review Comments	Action Taken
01/02/2026	Jane Smith	Protocol updated for new equipment	Completed

Annexure-6: Cleaning Validation Records

Validation ID	Cleaning Method	Result	Validation Date
CV-001	Manual Cleaning	Pass	01/03/2026

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial Version	New SOP Creation	QA Head
01/02/2025	2.0	Updated cleaning validation protocol	Revised cleaning methods	QA Head