safety standards.

Production Team: Responsible for executing the revalidation runs according to the revalidation protocol, documenting the results, and reporting any deviations or issues during production.

Regulatory Affairs Team: Ensures that the revalidation process complies with all applicable regulatory standards and guidelines and is properly documented for audits and inspections.

4. Accountability

The Manufacturing Manager is accountable for ensuring that the revalidation process is properly executed according to this SOP. The overall compliance with this SOP is overseen by the Quality Assurance (QA) Manager.

5. Procedure

5.1. Identifying the Need for Revalidation

1. Revalidation should be initiated whenever a change is made that could impact the aerosol manufacturing process or product quality. Common reasons for revalidation include:
   • Changes in the formulation (e.g., new raw materials, change in ingredient concentration)
   • Modifications to equipment or machinery (e.g., replacement, upgrade, or calibration)
   • Changes in process parameters (e.g., temperature, pressure, filling speed)
   • Corrective actions taken after process deviations or non-conformities
   • Regulatory changes that impact process requirements
2. Any change that may affect the quality of the final product, process efficiency, or regulatory compliance should trigger the revalidation process.

5.2. Developing the Revalidation Protocol

1. Once the need for revalidation is identified, a revalidation protocol should be developed that outlines the following:
   • Objective: To verify that the process still meets the required product specifications after the change has been made.
   • Scope: A detailed description of the changes made and which process steps will be included in the revalidation (e.g., formulation, filling, crimping).
   • Critical Process Parameters (CPPs): The key parameters to be monitored during revalidation, including those affected by the changes made (e.g., filling volume, pressure, temperature).
   • Acceptance Criteria: Defined ranges and limits for the CPPs that must be met during revalidation (e.g., acceptable spray rate, filling accuracy, product stability).
   • Sampling Plan: The number of samples to be tested, the frequency of sampling, and the types of tests to be conducted (e.g., stability tests, chemical composition, appearance).
   • Methodology: The step-by-step process for performing revalidation, including test procedures and data recording methods.
2. The protocol should be reviewed and approved by the QA team to ensure it aligns with GMP and regulatory requirements.

5.3. Performing Revalidation Runs

1. Revalidation runs should be conducted following the revalidation protocol, ensuring that all parameters are monitored and documented. Key activities include:
   • Monitoring and documenting CPPs (e.g., filling volume, spray rate, temperature, humidity)
   • Collecting quality control data (e.g., product appearance, pH, chemical composition)
   • Recording any deviations or issues during the revalidation runs
2. All collected data should be documented in the Revalidation Data Report (Annexure-1). The report should include:
   • Batch number and production details
   • Recorded values for each monitored parameter
   • Test results and comparison to acceptance criteria
   • Any deviations and the corrective actions taken
3. If deviations are observed, immediate corrective actions should be taken, and the process should be stopped until the root cause is identified and corrected. The Deviation Log (Annexure-2) should be completed to document the deviation and corrective actions taken.

5.4. Reviewing Revalidation Results

1. After the revalidation runs are complete, the QA team should review the revalidation data to ensure that all parameters meet the predefined acceptance criteria. This review should include:
   • Verification of accuracy and completeness of the revalidation records
   • Comparison of the revalidation results with the original process specifications
   • Identification of any deviations or anomalies and their potential impact on product quality
   • Confirmation that corrective actions were effective and that the process meets all quality and regulatory requirements
2. If the revalidation results indicate that the process is not capable of meeting the required specifications, further investigation and corrective actions will be required. Revalidation may need to be repeated or adjustments made to the process to ensure compliance.

5.5. Documenting and Reporting Revalidation Results

1. The results of the revalidation process should be documented in a final Revalidation Report (Annexure-3). This report should include:
   • A summary of the changes made and the reasons for revalidation
   • Details of the revalidation runs, including all monitored parameters and test results
   • Any deviations or non-conformities and the corrective actions taken
   • Conclusions regarding the process’s ability to consistently meet product specifications
2. The Revalidation Report should be reviewed and approved by the QA team and other relevant departments. Once approved, the report should be archived and stored for future reference and regulatory inspections.

5.6. Ongoing Monitoring and Requalification

1. If the process is successfully revalidated, ongoing monitoring should continue during routine production to ensure that it remains within acceptable limits. The following activities should be conducted regularly:
   • Periodic review of process performance
   • Requalification of equipment and processes as required
   • Continual verification that process parameters remain under control
2. Any significant changes to the process or equipment should trigger revalidation, and the revalidation protocol should be updated accordingly.

6. Abbreviations

• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• SOP: Standard Operating Procedure
• CPP: Critical Process Parameter
• CFR: Code of Federal Regulations
• CAPA: Corrective and Preventive Action

7. Documents

1. Revalidation Data Report (Annexure-1)
2. Deviation Log (Annexure-2)
3. Revalidation Report (Annexure-3)

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: Revalidation Data Report

Batch Number	Revalidation Date	Result	Remarks
Batch-001	10/02/2025	Pass	Process remains within acceptable range

Annexure-2: Deviation Log

Deviation ID	Deviation Description	Corrective Action	Assigned To	Status
DEV-12345	Temperature fluctuation during filling	Re-calibrated equipment	Rajesh Patel	Completed

Annexure-3: Revalidation Report

Batch Number	Revalidation Date	Conclusion	Remarks
Batch-001	10/02/2025	Pass	Process validated successfully

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