executing the validation protocol and documenting the results during the equipment validation process.

4. Accountability

The Manufacturing Manager is accountable for ensuring that equipment validation protocols are prepared and executed as part of the equipment qualification process. The overall compliance with this SOP is overseen by the Quality Assurance (QA) Manager.

5. Procedure

5.1. Preparing the Equipment Validation Protocol

1. The equipment validation protocol should be prepared for each piece of equipment used in aerosol manufacturing. The protocol should be developed before the equipment is installed or used for production purposes.
2. The validation protocol should include the following sections:
   • Objective: The objective of the validation process, specifying what the validation aims to achieve (e.g., confirming equipment functionality, verifying performance criteria).
   • Scope: A description of the equipment to be validated, including its model, serial number, location, and any relevant operational parameters.
   • Acceptance Criteria: The criteria that must be met for the equipment to be considered validated. These should be based on manufacturer specifications and regulatory requirements, such as filling accuracy, cycle time, crimping consistency, etc.
   • Test Methods: The test methods that will be used to verify the equipment’s performance. These may include functional tests, performance tests, and safety checks.
   • Responsibilities: The roles and responsibilities of the personnel involved in the validation process, including those responsible for performing the tests, reviewing the results, and approving the protocol.
   • Documentation: The documentation requirements for the validation process, including forms, test logs, and any required reports (e.g., Validation Report, Deviation Log).
   • Schedule: The timeline for completing the validation process, including testing and approval stages.
3. The protocol should be tailored to the specific equipment and its intended use in aerosol manufacturing, ensuring that all relevant performance aspects are covered.
4. Ensure that the validation protocol is comprehensive, clear, and free from ambiguities, outlining all necessary steps for successful validation.

5.2. Reviewing the Validation Protocol

1. Once the equipment validation protocol is prepared, it should be reviewed by the Engineering, Production, and QA teams to ensure that it is comprehensive, accurate, and compliant with regulatory standards.
2. The protocol should be checked to ensure that the following points are addressed:
   • All necessary performance parameters and test conditions are specified.
   • The acceptance criteria are achievable and aligned with equipment specifications.
   • The roles and responsibilities of personnel involved in validation are clearly defined.
3. Any discrepancies or missing information should be addressed before the protocol is approved for execution.
4. Once the review is complete, the protocol should be approved by the QA team, and the final version should be signed and dated by the responsible personnel.

5.3. Approving the Validation Protocol

1. After review and revisions, the finalized validation protocol should be approved by the QA team. The approval process ensures that the protocol meets GMP and regulatory requirements and that the tests will be effective in verifying the equipment’s performance.
2. The approved protocol should be stored in a secure location, easily accessible for reference during the validation process and audits.

5.4. Implementing the Validation Protocol

1. Once the protocol is approved, the validation process can begin. The validation team should follow the protocol exactly as outlined, performing all necessary tests and documenting the results.
2. Ensure that all deviations from the protocol are documented in the Deviation Log (Annexure-1), and corrective actions are taken as necessary.
3. After completion of the validation tests, the results should be compiled into a Validation Report (Annexure-2), and any corrective actions taken should be documented and reviewed by the QA team.

5.5. Finalizing and Storing the Validation Protocol

1. Once the validation process is complete and the equipment has been approved for use, the validation protocol and all associated documentation (e.g., test results, deviation logs) should be archived for future reference and audits.
2. All documentation should be maintained in a secure location with controlled access to ensure compliance with GMP guidelines and regulatory requirements.

6. Abbreviations

• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• SOP: Standard Operating Procedure
• CAPA: Corrective and Preventive Action
• OQ: Operational Qualification
• PQ: Performance Qualification

7. Documents

1. Equipment Validation Protocol (Annexure-1)
2. Validation Report (Annexure-2)
3. Deviation Log (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: Equipment Validation Protocol

Protocol ID	Equipment ID	Test Parameters	Acceptance Criteria	Test Date	Results
EVP-001	FILL-001	Filling Accuracy, Cycle Time, Pressure	±0.5% for filling accuracy	06/02/2025	Pass

Annexure-2: Validation Report

Test Type	Test Results	Deviations	Corrective Action
Filling Accuracy	±0.2% deviation	No deviation	None

Annexure-3: Deviation Log

Deviation ID	Deviation Description	Corrective Action	Assigned To	Status
DEV-12345	Filling accuracy out of tolerance	Recalibrated the machine	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 protocol preparation procedures	To comply with updated GMP regulations	Anjali Sharma	Page 1	[Ref Point]	Updated procedures