protocol.

Quality Assurance (QA) Team: Responsible for reviewing and approving the validation protocol and ensuring that the process validation activities comply with GMP, regulatory guidelines, and internal quality standards.

Regulatory Affairs Team: Ensures the validation protocol aligns with applicable regulatory requirements and monitors compliance with regulatory guidelines throughout the validation process.

4. Accountability

The Manufacturing Manager is accountable for ensuring that the validation protocols are generated and executed in accordance with this SOP. The overall compliance with this SOP is overseen by the Quality Assurance (QA) Manager.

5. Procedure

5.1. Developing the Validation Protocol

1. The validation protocol should be developed for each aerosol product and the associated manufacturing process. The protocol must include the following elements:
   • Title and Objective: Clear title and objective outlining the validation process (e.g., Process Validation, Equipment Qualification, Cleaning Validation).
   • Scope: Description of the scope of the validation, including the equipment, processes, and parameters to be validated.
   • Test Parameters: Definition of the critical process parameters (CPPs) that affect the quality of the final product. These parameters should include both in-process and end-product quality attributes (e.g., spray rate, filling accuracy, propellant concentration).
   • Acceptance Criteria: Clear criteria outlining what constitutes a successful validation run, including limits for all test parameters (e.g., ±5% for filling accuracy, pH range for formulation).
   • Sampling Plan: A sampling plan detailing the frequency of testing, number of samples to be tested, and any additional tests required at different stages of the process.
   • Methodology: Step-by-step instructions for executing the validation, including specific actions for each stage of the process.
   • Roles and Responsibilities: Clear definition of roles and responsibilities of each team involved in the validation process (e.g., validation team, production team, QA team).
2. The protocol should be reviewed and approved by the QA team to ensure it aligns with GMP standards, regulatory requirements, and the specific needs of the product.

5.2. Protocol Review and Approval

1. The draft protocol must be reviewed by relevant departments, including QA, production, regulatory affairs, and validation. Each department must ensure that the protocol meets their requirements and that all critical aspects of the process are covered.
2. Once the protocol is reviewed and final adjustments are made, it should be signed and approved by the QA Manager and Manufacturing Manager. The approved protocol should be stored and referenced throughout the validation process.

5.3. Conducting the Validation Runs

1. Once the validation protocol is approved, the validation runs should be conducted following the established protocol. The production team will execute the manufacturing process according to the protocol, ensuring all specified parameters are met.
2. During validation, the following steps should be closely monitored:
   • Monitor the identified critical process parameters (e.g., pressure, temperature, filling volume).
   • Perform quality control tests on the product (e.g., appearance, chemical composition, spray rate) to ensure that it meets the acceptance criteria.
   • Record data accurately for all test parameters and deviations, if any.
3. All records from the validation runs should be collected and compiled in the Process Validation Report (Annexure-1), which will include the results of all tests, any deviations or non-conformities, and corrective actions taken.

5.4. Documentation and Reporting

1. After completing the validation runs, the results must be documented in a comprehensive validation report. The Process Validation Report should include:
   • Summary of validation runs
   • Test results for each parameter
   • Analysis of deviations and corrective actions taken
   • Final conclusions on the process’s ability to meet required specifications
2. The report must be reviewed and approved by the QA team and relevant departments to ensure that all data is accurate and the process meets all requirements.
3. The final validated process and protocol must be documented and archived for future reference and regulatory audits.

5.5. Revalidation

1. Revalidation is required if significant changes are made to the process, equipment, or formulation that could impact the process or product quality. In such cases, the validation protocol should be revised and re-executed according to the same procedures outlined in this SOP.
2. Revalidation should also be considered if process deviations occur during routine production or if quality control tests indicate that product quality may be affected.

6. Abbreviations

• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• SOP: Standard Operating Procedure
• CPP: Critical Process Parameter
• OQ: Operational Qualification
• PQ: Performance Qualification
• CFR: Code of Federal Regulations

7. Documents

1. Process Validation Report (Annexure-1)
2. Deviation 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 Date	Result	Remarks
Batch-001	10/02/2025	Pass	All parameters within acceptable range

Annexure-2: Deviation Log

Deviation ID	Deviation Description	Corrective Action	Responsible Person	Status
DEV-12345	Temperature fluctuation	Recalibrated temperature control	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 validation protocol generation process	To comply with updated GMP regulations	Anjali Sharma	Page 1	[Ref Point]	Updated procedures