SOP Guide for Pharma

Aerosol: SOP for Review of Cleaning Validation Data – V 2.0

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Aerosol: SOP for Review of Cleaning Validation Data – V 2.0

SOP for Review of Cleaning Validation Data

Department Aerosol
SOP No. SOP/Aerosol/087/2025
Supersedes SOP/Aerosol/087/2022
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) defines the process for reviewing cleaning validation data in aerosol manufacturing. The purpose is to ensure that the cleaning process for equipment used in aerosol production is effective in removing residues of active ingredients, excipients, and contaminants to an acceptable level. Proper review of cleaning validation data ensures compliance with GMP and product safety standards.

2. Scope

This SOP applies to all cleaning validation activities for equipment used in aerosol manufacturing at [Company Name]. It includes the review of cleaning validation protocols, execution data, and results to verify the effectiveness of cleaning procedures and ensure compliance with regulatory requirements.

3. Responsibilities

4. Accountability

The Manufacturing Manager is accountable for ensuring that cleaning validation is conducted and reviewed according to this SOP. The overall compliance with this SOP is overseen by the Quality Assurance (QA) Manager.

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5. Procedure

5.1. Cleaning Validation Protocol

  1. Before initiating a cleaning validation, the QC team must prepare a Cleaning Validation Protocol (Annexure-1). This protocol should include:
    • Objectives of the cleaning validation
    • List of equipment to be validated
    • Detailed cleaning procedures (e.g., cleaning agents, concentrations, cleaning methods)
    • Acceptance criteria (e.g., residue limits for active ingredients, excipients, or contaminants)
    • Sampling methods and locations
    • Testing procedures (e.g., swab sampling, rinse sampling, analytical methods)
  2. The protocol should be reviewed and approved by the QA team before execution.

5.2. Cleaning Validation Execution

  1. The cleaning validation process should be executed as per the approved protocol. The production team should perform cleaning procedures on the equipment, and samples should be collected for testing as defined in the protocol.
  2. Samples should be analyzed for residues of the active ingredient, excipients, or any contaminants. The analytical methods used for residue analysis should be validated and documented in the protocol.
  3. The results of the cleaning validation execution should be documented in the Cleaning Validation Execution Report (Annexure-2). This report should include:
    • Details of the cleaning procedures followed
    • Sample collection and analysis results
    • Any deviations from the cleaning procedure or protocol
    • Conclusion regarding the effectiveness of the cleaning procedure
  4. Once the cleaning validation is completed, the results should be forwarded to the QC team for review.

5.3. Review of Cleaning Validation Data

  1. The QC team is responsible for reviewing the Cleaning Validation Execution Report and ensuring that the cleaning process is effective. The review should include:
    • Verification that the sampling locations and methods are in compliance with the protocol.
    • Verification that the analytical methods used for residue testing are appropriate and validated.
    • Verification that the cleaning process met the acceptance criteria (e.g., no detectable residues of active ingredients or contaminants).
    • Investigation of any deviations or failures in the cleaning process and determining the root cause of the issue.
  2. If any issues or deviations are found, corrective actions should be implemented. These corrective actions should be documented in the Corrective Action Log (Annexure-3).
  3. Once the review is complete and the cleaning validation data is found to be acceptable, the report should be approved by the QC team and the QA team.
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5.4. Final Approval and Documentation

  1. After the cleaning validation review, the QA team will approve the final Cleaning Validation Report (Annexure-4). This report should include the following:
    • Summary of the cleaning validation process
    • Summary of the review of validation data
    • Conclusions and approval of the cleaning process
    • Recommendations for future cleaning procedures or improvements, if necessary
  2. All cleaning validation records, including the protocol, execution report, review notes, and final approval, should be stored in the document management system for future reference and regulatory inspections.

5.5. Monitoring and Revalidation

  1. Cleaning validation should be revalidated periodically or whenever there is a change in the manufacturing process, equipment, or cleaning procedures.
  2. The frequency of revalidation should be based on the criticality of the equipment and the risk of contamination. This should be determined by the risk assessment process and documented in the Cleaning Validation Plan.
  3. Any changes to the cleaning process, materials, or equipment should be evaluated for their impact on the cleaning procedure and validated as necessary.
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6. Abbreviations

7. Documents

  1. Cleaning Validation Protocol (Annexure-1)
  2. Cleaning Validation Execution Report (Annexure-2)
  3. Corrective Action Log (Annexure-3)
  4. Cleaning Validation Report (Annexure-4)

8. References

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

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

Protocol ID Equipment ID Cleaning Method Acceptance Criteria Sampling Locations Test Method
CVP-001 FILL-001 Manual Cleaning No active ingredient residues detected Filling machine surfaces, nozzle Swab sampling, HPLC testing

Annexure-2: Cleaning Validation Execution Report

Batch Number Cleaning Date Operator Sample Results Pass/Fail
Batch-001 06/02/2025 Rajesh Patel 0.05 ppm active ingredient residue Pass

Annexure-3: Corrective Action Log

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Deviation ID Corrective Action Implementation Date Responsible Person Status
DEV-12345 Re-calibrated cleaning equipment 07/02/2025 Rajesh Patel Completed

Annexure-4: Cleaning Validation Report

Batch Number Cleaning Method Validation Results Approved By Comments
Batch-001 Manual Cleaning Passed residue limits Anjali Sharma No further actions required

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 cleaning validation process To comply with updated GMP regulations Anjali Sharma Page 1 [Ref Point] Updated procedures
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