SOP for Periodic Review of Cleaning Validation Data

Department	Aerosol
SOP No.	SOP/Aerosol/127/2025
Supersedes	SOP/Aerosol/127/2022
Page No.	Page 1 of Y
Issue Date	06/02/2025
Effective Date	16/02/2025
Review Date	06/02/2028

1. Purpose

This Standard Operating Procedure (SOP) provides guidelines for the periodic review of cleaning validation data for aerosol manufacturing equipment. The purpose of this SOP is to ensure that cleaning validation remains effective and consistent over time, and that any changes to equipment, cleaning agents, or processes are thoroughly evaluated. Regular review of cleaning validation data helps to identify trends, potential risks, and opportunities for improvement in the cleaning process, ensuring continued compliance with Good Manufacturing Practices (GMP) and regulatory standards.

2. Scope

This SOP applies to the periodic review of cleaning validation data for all aerosol manufacturing equipment, including filling machines, pumps, nozzles, and any other components that come into contact with the product. The SOP covers the review of cleaning validation reports, test results, sampling data, and any corrective actions taken in response to deviations or failures in the cleaning process.

3. Responsibilities

• QA Team: Responsible for performing the periodic review of cleaning validation data, identifying trends and areas of concern, and ensuring compliance with GMP and regulatory requirements.
• Validation Team: Responsible for supporting the review process by providing historical validation data, test results, and corrective actions for any deviations that occurred during the cleaning validation process.
• Production Team: Responsible for providing feedback and any operational data that may be relevant to the periodic review of cleaning validation data.
• Regulatory Affairs Team: Ensures that the review process complies with applicable regulatory standards and guidelines.

4. Accountability

The Manufacturing Manager is accountable for ensuring that periodic reviews of cleaning validation data are conducted as per this SOP. The overall compliance with this SOP is overseen by the Quality Assurance (QA) Manager.

5. Procedure

5.1. Frequency of Periodic Review

1. The periodic review of cleaning validation data should be conducted at least once every 12 months or more frequently if any of the following occur:
   • Changes are made to the cleaning process, equipment, or formulation
   • Deviations or non-conformities occur during the cleaning process
   • Regulatory requirements are updated
2. The review process should be initiated by the QA team based on the cleaning validation schedule or as needed, following significant changes in the production process or cleaning procedure.

5.2. Collecting Cleaning Validation Data

1. The following data should be collected for review:
   • Historical cleaning validation reports, including residue levels, sampling points, and test results (Annexure-1)
   • Deviation logs and corrective actions taken (Annexure-2)
   • Results of any revalidation or re-cleaning procedures performed
   • Trends in cleaning process performance, including any recurring issues or failures
   • Feedback from production and maintenance teams regarding the cleaning process and equipment performance
2. The data should be organized and reviewed to identify any deviations, trends, or areas for improvement in the cleaning process.

5.3. Review of Cleaning Validation Data

1. The QA team should review the collected cleaning validation data to evaluate the effectiveness of the cleaning process. The review should include:
   • Comparison of historical cleaning validation data with established acceptance criteria to verify that residues are consistently within acceptable limits.
   • Review of any deviations or failures in the cleaning process, including corrective actions taken and the effectiveness of those actions.
   • Analysis of trends in the cleaning process, such as recurring issues with certain equipment or surfaces, changes in residue levels over time, or changes in the cleaning process.
   • Evaluation of the adequacy of sampling points, sampling methods, and analytical test methods used in the cleaning validation process.
2. If any areas of concern or opportunities for improvement are identified during the review, corrective actions should be proposed and implemented.

5.4. Corrective Actions and Improvements

1. If the review identifies any deficiencies or areas for improvement, corrective actions should be taken. These may include:
   • Re-evaluating and updating the cleaning procedure to address any issues identified during the review.
   • Modifying or adding sampling points if necessary to ensure all critical areas are adequately cleaned and validated.
   • Re-validating the cleaning process or conducting additional cleaning runs if residue levels are found to exceed acceptable limits.
   • Implementing additional training for production or maintenance teams if recurring issues are linked to operational factors.
2. The corrective actions should be documented in the Deviation Log (Annexure-2) and monitored to ensure that the actions are effective in addressing the identified issues.

5.5. Reporting and Documentation

1. Once the review and corrective actions are completed, the results of the periodic review should be documented in the Periodic Review Report (Annexure-3). The report should include:
   • A summary of the data reviewed, including historical cleaning validation data and trends
   • Any deviations or issues identified during the review, including corrective actions taken
   • Recommendations for improvements to the cleaning process or procedures
   • A conclusion regarding the ongoing effectiveness of the cleaning validation process
2. The Periodic Review Report should be reviewed and approved by the QA team. Once approved, the report should be filed and stored as part of the cleaning validation documentation.

5.6. Revalidation and Continuous Improvement

1. Based on the periodic review results, revalidation of the cleaning process may be necessary if significant issues or trends are identified. Revalidation should follow the process outlined in the cleaning validation protocol, with updated sampling plans, test methods, and acceptance criteria as needed.
2. Ongoing monitoring and continuous improvement of the cleaning process should be encouraged to ensure that the equipment remains compliant with GMP and regulatory standards over time.

6. Abbreviations

• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• SOP: Standard Operating Procedure
• CAPA: Corrective and Preventive Action

7. Documents

1. Periodic Review Report (Annexure-3)
2. Deviation Log (Annexure-2)
3. Cleaning Validation Report (Annexure-1)

8. References

This SOP is based on the following regulatory guidelines and industry standards:

• Good Manufacturing Practice (GMP) Guidelines
• FDA Code of Federal Regulations (CFR) Title 21, Part 211
• International Council for Harmonisation (ICH) Guidelines

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 Report

Batch Number	Test Date	Residue Level	Acceptance Criteria	Result
Batch-001	10/02/2025	Detergent	Less than 5 ppm	Pass

Annexure-2: Deviation Log

Deviation ID	Deviation Description	Corrective Action	Assigned To	Status
DEV-12345	Residue above limit	Adjusted cleaning procedure	Rajesh Patel	Completed

Annexure-3: Periodic Review Report

Batch Number	Review Date	Review Results	Corrective Actions	Remarks
Batch-001	10/02/2025	No issues observed	None	Cleaning process remains effective

12. Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By	Page No.	Ref. Point No.	Details of Revision
01/01/2024	V 1.0	Initial Release	First Issue	Anjali Sharma	Page 1	[Ref Point]	First Release
01/01/2025	V 2.0	Updated review process	To comply with updated GMP regulations	Anjali Sharma	Page 1	[Ref Point]	Updated procedures