meet GMP standards and regulatory requirements.

Maintenance Team: Responsible for ensuring that the filling machines are maintained in optimal condition prior to conducting the OQ process and addressing any maintenance issues that may arise during the qualification process.

4. Accountability

The Manufacturing Manager is accountable for ensuring that the Operational Qualification of filling machines is conducted and documented according to this SOP. The overall compliance with this SOP is overseen by the Quality Assurance (QA) Manager.

5. Procedure

5.1. Preparing for Operational Qualification

1. Before starting the OQ process, ensure that the filling machines are installed and the equipment is ready for testing, following the Installation Qualification (IQ) protocol.
2. Ensure that all necessary equipment, instruments, and documentation are available, including calibration tools, test weights, and the OQ protocol.
3. Verify that the filling machine is clean and free from contaminants before starting the OQ process.
4. Establish the OQ team, which should include representatives from the Engineering, Production, and QA teams.
5. Review the filling machine’s technical manual and manufacturer specifications to confirm the operational parameters to be tested during the OQ process.

5.2. Conducting the Operational Qualification

1. The following tests should be conducted during the OQ process:
   • Filling Accuracy: Test the accuracy of the filling machine by checking the amount of product dispensed in each cycle using calibrated test containers or weights.
   • Cycle Time: Measure the time it takes to complete a full cycle of the filling machine, ensuring that it meets the specified limits for production speed.
   • Pressure Testing: Test the pressure settings for propellant filling machines to ensure that the pressure is maintained within the required range.
   • Temperature Settings: Verify that the filling machine maintains the specified temperature settings for sensitive products or formulations.
   • Leak Testing: Perform leak tests to ensure that the machine and its components are sealed properly and do not cause any loss of product or propellant during filling.
2. Verify that all machine settings (e.g., volume, speed, pressure, temperature) are within the manufacturer’s specifications and the operational parameters established for production.
3. Each test should be performed three times to ensure consistent performance and accuracy. Record the results in the Operational Qualification Report (Annexure-1).

5.3. Documenting the Operational Qualification

1. Document the following information in the Operational Qualification Report (Annexure-1):
   • The equipment ID, model, and serial number of the filling machine
   • Details of the tests performed, including test conditions, settings, and equipment used
   • Results of the filling accuracy, cycle time, pressure, temperature, and leak tests
   • Any deviations observed during testing, along with corrective actions taken
   • The name of the personnel who performed the qualification tests
   • Approval signatures from the Engineering, Production, and QA teams
2. The Operational Qualification Report should be signed by the responsible team members and reviewed by the QA team.

5.4. Reviewing and Approving the Operational Qualification

1. The QA team should review the Operational Qualification Report to ensure that all tests were performed according to the specifications and that the results meet the required standards for filling machine operation.
2. If any deviations are observed during the OQ process, they should be documented in the Deviation Log (Annexure-2). Corrective actions should be implemented, and the tests should be repeated to verify the effectiveness of the corrective actions.
3. The QA team should approve the report once all tests are complete and any deviations have been addressed.

5.5. Finalizing the OQ Process

1. Once the Operational Qualification is completed and approved, the filling machine can proceed to the Performance Qualification (PQ) phase, or it can be used for production, depending on the next steps defined in the equipment qualification process.
2. All documentation, including the Operational Qualification Report and any supporting documents (e.g., deviation reports, corrective actions), should be archived and accessible for future audits and reviews.

6. Abbreviations

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

7. Documents

1. Operational Qualification 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: Operational Qualification Report

Equipment ID	Model Number	Serial Number	Test Date	Test Type	Result
FILL-001	Model A	SN123456	06/02/2025	Filling Accuracy	Pass
FILL-001	Model A	SN123456	06/02/2025	Cycle Time	Pass

Annexure-2: Deviation Log

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