authorities such as the FDA and ICH, and verifies that the validation results are in compliance with regulatory guidelines.

4. Accountability

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

5. Procedure

5.1. Process Validation Protocol Development

1. A process validation protocol must be developed for each aerosol manufacturing process. The protocol should include the following:
   • Objective of validation (e.g., to confirm that the process consistently produces products that meet specifications)
   • Scope of validation (e.g., specific stages of manufacturing to be validated)
   • Validation parameters (e.g., temperature, pressure, flow rates, material weight, formulation consistency)
   • Sampling plan for trial batches
   • Criteria for acceptance (e.g., product quality, stability data, performance tests)
   • Details of equipment used in the manufacturing process
2. The protocol should be reviewed and approved by the QA and Regulatory Affairs teams before the validation study begins.

5.2. Conducting Process Validation Runs

1. Process validation must be conducted on a batch scale that simulates commercial production conditions. Trial batches should be produced using the same equipment, materials, and process parameters that will be used for commercial production.
2. The validation runs should cover all aspects of the manufacturing process, including formulation preparation, filling, and packaging. Parameters that should be monitored during the validation runs include:
   • Formulation consistency
   • Filling accuracy and uniformity
   • Packaging integrity
   • Quality control testing (e.g., chemical composition, physical properties, performance)
3. The results from the validation runs should be documented in the Process Validation Report (Annexure-1) and compared with the acceptance criteria defined in the protocol.

5.3. Monitoring and Documentation

1. During the validation runs, data should be collected for each parameter being tested, and all observations should be documented in real-time. The following should be monitored:
   • Critical process parameters (e.g., temperature, humidity, pressure, material flow)
   • Product performance and quality attributes (e.g., spray rate, appearance, stability)
   • Equipment performance (e.g., machine settings, efficiency, downtime)
2. Documentation should include:
   • Batch records for the trial batches
   • Process parameters and settings for each validation run
   • Results of quality control testing
   • Any deviations or non-conformities that occurred during the validation process
3. All data should be compiled in the Process Validation Report (Annexure-1), which should be reviewed by the QA team to ensure that the process meets the required specifications.

5.4. Process Validation Report and Approval

1. After the validation runs are completed, the Process Validation Report must be prepared. This report should summarize the following:
   • The objective and scope of the validation
   • Detailed results of the trial batches, including product quality, process parameters, and equipment performance
   • Analysis of any deviations or non-conformities, including corrective actions taken
   • Conclusions on the capability of the process to consistently produce products that meet specifications
2. The report should be reviewed by the QA team and approved by the Manufacturing Manager, with the final approval documented in the Process Validation Approval Log (Annexure-2).
3. Once the process is validated, the results should be used as a reference for future production runs and to confirm that the manufacturing process consistently meets quality specifications.

5.5. Re-validation of Processes

1. Process validation should be re-executed under the following conditions:
   • Significant changes to the formulation or manufacturing process
   • Changes to equipment or materials used in the production process
   • Any failure in the process during routine production
2. Re-validation protocols should follow the same process as the initial validation, including reviewing and revising the protocol as necessary and documenting any new findings in the updated Process Validation Report (Annexure-1).

6. Abbreviations

• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• SOP: Standard Operating Procedure
• RH: Relative Humidity
• CFR: Code of Federal Regulations
• CAPA: Corrective and Preventive Action
• FDA: Food and Drug Administration

7. Documents

1. Process Validation Report (Annexure-1)
2. Process Validation Approval Log (Annexure-2)

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: Process Validation Report

Batch Number	Validation Start Date	Validation Duration	Test Conditions	Validation Results	Operator Name
Batch-001	10/02/2025	3 months	25°C/60% RH	Pass	Rajesh Patel

Annexure-2: Process Validation Approval Log

Approval ID	Approval Date	Approved By	Comments
APP-12345	15/02/2025	Anjali Sharma	Approved for release

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