SOP Guide for Pharma

Aerosol: SOP for Revalidating Cleaning Processes After Modifications – V 2.0

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Aerosol: SOP for Revalidating Cleaning Processes After Modifications – V 2.0

SOP for Revalidating Cleaning Processes After Modifications

Department Aerosol
SOP No. SOP/Aerosol/128/2025
Supersedes SOP/Aerosol/128/2022
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) outlines the process for revalidating cleaning processes after modifications to aerosol manufacturing equipment, cleaning agents, or procedures. The objective of this SOP is to ensure that any changes made to the equipment or cleaning process do not affect the efficacy of the cleaning process or the quality of the product. Revalidation ensures that the cleaning procedures remain effective and compliant with Good Manufacturing Practices (GMP) and regulatory requirements following modifications.

2. Scope

This SOP applies to the revalidation of cleaning processes for all aerosol manufacturing equipment, including filling machines, valves, pumps, nozzles, and any other components that come into contact with the product. This SOP covers the process of revalidation whenever modifications are made to the equipment, cleaning agents, formulations, or cleaning procedures.

3. Responsibilities

4. Accountability

The Manufacturing Manager is accountable for ensuring that cleaning processes are revalidated after modifications are made. The overall compliance with this SOP is overseen by the Quality Assurance (QA) Manager.

5. Procedure

5.1. Identifying Modifications That Require Revalidation

  1. Revalidation should be initiated if any of the following modifications are made:
    • Changes to the cleaning procedure, including new cleaning agents, equipment, or cleaning techniques.
    • Modifications to the aerosol manufacturing equipment, such as new parts, components, or systems that come into direct contact with the product.
    • Changes in the formulation or raw materials that may affect the cleaning process (e.g., new ingredients that leave residues that are harder to clean).
    • Changes in regulatory requirements that impact cleaning standards or validation criteria.
  2. Once modifications are identified, the revalidation process should be planned and executed to ensure that the cleaning process remains effective and compliant.
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5.2. Reviewing the Modified Cleaning Process

  1. Before starting the revalidation, the modified cleaning process should be reviewed to identify any potential impact on the cleaning process:
    • Review the changes made to the equipment or cleaning agents to determine whether they could affect residue levels or the effectiveness of the cleaning process.
    • Identify any new surfaces, materials, or components that may require additional sampling or testing during the revalidation process.
    • Review the acceptance criteria to ensure they remain appropriate for the modified process and equipment.
  2. The review should be documented, and any necessary adjustments should be made to the revalidation protocol to address the modifications.

5.3. Preparing the Revalidation Protocol

  1. The revalidation protocol should be prepared to include:
    • Objective: The purpose of the revalidation, including the modifications that prompted the revalidation.
    • Scope: The areas affected by the modifications and the cleaning processes that require revalidation.
    • Acceptance Criteria: The residue limits, microbial contamination limits, and any other criteria that need to be met after the cleaning process.
    • Sampling Plan: The sampling locations, methods (e.g., surface swabbing or rinse water sampling), and frequency of sampling required for the revalidation.
    • Test Methods: The analytical methods to be used for testing the residue levels and microbial contamination (e.g., HPLC, spectrophotometry, microbial tests).
    • Schedule: The timeline for conducting the revalidation, including the number of cleaning runs and sample collection dates.
    • Personnel Responsibilities: The roles and responsibilities of the teams involved in the revalidation process.
  2. The protocol should be reviewed and approved by the QA team before it is executed.
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5.4. Executing the Revalidation

  1. Once the revalidation protocol is approved, the revalidation process should be carried out according to the defined procedures. This includes:
    • Cleaning the equipment following the modified cleaning procedure and sampling the cleaned surfaces or rinse water for residue analysis.
    • Performing any microbial tests required to verify that the cleaning process has removed any potential microbial contamination.
    • Analyzing the collected samples using the specified test methods to determine if the cleaning process meets the established acceptance criteria.
  2. The revalidation process should include at least three successful cleaning runs to confirm the consistency and effectiveness of the modified cleaning process.

5.5. Reviewing Revalidation Results

  1. After the revalidation is complete, the results should be reviewed to ensure that the modified cleaning process meets the acceptance criteria. The review should include:
    • Comparison of the revalidation results with the established acceptance criteria for residue and microbial contamination.
    • Analysis of any deviations or failures in the cleaning process, including corrective actions taken to address the issues.
    • Review of the effectiveness of any corrective actions implemented during the revalidation process.
  2. If the revalidation results meet the established criteria, the cleaning process can be considered validated and suitable for use in subsequent production runs.
  3. If the results do not meet the criteria, the cleaning procedure should be modified further, and the revalidation process should be repeated until acceptable results are achieved.
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5.6. Documenting Revalidation Results

  1. All revalidation activities should be documented in the Revalidation Report (Annexure-1). The report should include:
    • The revalidation protocol, including the modifications made to the cleaning process and equipment.
    • The results of the residue and microbial testing, including detailed analysis and any deviations.
    • Any corrective actions taken and their effectiveness in addressing deviations.
    • Approval from the QA team confirming that the revalidation process was successful and the cleaning procedure is effective.
  2. The Revalidation Report should be reviewed and approved by the QA team. Once approved, the report should be stored as part of the cleaning validation documentation.

6. Abbreviations

7. Documents

  1. Revalidation Report (Annexure-1)
  2. Deviation Log (Annexure-2)

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: Revalidation 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

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