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

5. Procedure

5.1. Equipment Qualification Process Overview

1. The equipment qualification process consists of three stages:
   • Installation Qualification (IQ): Ensures that the equipment is installed correctly and meets the manufacturer’s specifications.
   • Operational Qualification (OQ): Verifies that the equipment operates as intended under specified conditions and that it meets the operational requirements.
   • Performance Qualification (PQ): Confirms that the equipment performs consistently and reliably during actual production conditions.
2. Each stage of qualification must be documented and reviewed before moving to the next stage.

5.2. Installation Qualification (IQ)

1. Installation Qualification ensures that the equipment has been properly installed according to the manufacturer’s guidelines and specifications. The following activities should be performed during IQ:
   • Verify that the equipment is installed in the correct location, with appropriate utilities (e.g., power, water, air) connected.
   • Ensure that all safety features and control systems are in place and functional.
   • Confirm that all components are present, and installation is complete as per the manufacturer’s specifications.
   • Document any discrepancies in the installation and address them before proceeding to the next stage.
2. The IQ report should include details such as:
   • Installation location
   • Equipment identification number
   • Calibration and verification results for key components
   • Any corrective actions taken

5.3. Operational Qualification (OQ)

1. Operational Qualification ensures that the equipment operates within the defined parameters and meets the required functional specifications. The following activities should be performed during OQ:
   • Verify that the equipment operates as intended under specified conditions (e.g., temperature, pressure, speed).
   • Test and validate all critical process control parameters (e.g., filling accuracy, propellant charging, spray rate).
   • Ensure that alarms, safety systems, and error messages are functioning correctly.
   • Perform a series of tests to assess the equipment’s ability to perform under normal operating conditions.
2. The OQ report should include:
   • Operational parameters tested
   • Test results for each parameter
   • Any deviations or non-conformities observed
   • Corrective actions taken to address deviations

5.4. Performance Qualification (PQ)

1. Performance Qualification ensures that the equipment can consistently produce aerosol products that meet quality specifications over time. The following activities should be performed during PQ:
   • Run production batches to verify that the equipment performs as expected during actual manufacturing conditions.
   • Test the final product for quality attributes such as appearance, performance (e.g., spray rate, actuator function), and chemical composition.
   • Monitor equipment performance during production to ensure consistency and reliability.
   • Perform additional tests if required to confirm long-term performance.
2. The PQ report should include:
   • Production batch data and test results
   • Performance data and verification against specifications
   • Analysis of any deviations or failures
   • Corrective actions taken to resolve any issues

5.5. Documentation and Record Keeping

1. All equipment qualification activities should be documented and stored securely for future reference and regulatory review. The following records should be maintained:
   • Installation Qualification Report (Annexure-1)
   • Operational Qualification Report (Annexure-2)
   • Performance Qualification Report (Annexure-3)
   • Corrective Action Log (Annexure-4)
2. Qualification records should be signed and dated by the responsible personnel. Records should be reviewed periodically to ensure they are complete and accurate.
3. Qualification records should be retained for a minimum of 3 years or as required by regulatory guidelines.

5.6. Requalification

1. If significant changes are made to the equipment (e.g., upgrades, repairs, or modifications), the equipment must undergo requalification to ensure continued compliance with the required specifications.
2. Requalification should follow the same process as initial qualification and should include IQ, OQ, and PQ, as necessary.

6. Abbreviations

• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• SOP: Standard Operating Procedure
• RH: Relative Humidity
• CFR: Code of Federal Regulations
• OQ: Operational Qualification
• PQ: Performance Qualification
• IQ: Installation Qualification

7. Documents

1. Installation Qualification Report (Annexure-1)
2. Operational Qualification Report (Annexure-2)
3. Performance Qualification Report (Annexure-3)
4. Corrective Action Log (Annexure-4)

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: Installation Qualification Report

Equipment ID	Installation Date	Installation Location	Verification Results	Remarks
Aerosol-Fill-001	15/02/2025	Line 3	Compliant	Ready for OQ

Annexure-2: Operational Qualification Report

Test Parameter	Test Conditions	Result	Remarks
Filling Accuracy	±1%	Pass	Operates as expected

Annexure-3: Performance Qualification Report

Batch Number	Test Date	Result	Remarks
Batch-001	17/02/2025	Pass	Meets all quality specifications

Annexure-4: Corrective Action Log

Action ID	Action Description	Assigned To	Completion Date	Remarks
ACT-12345	Re-calibrated filling system	Rajesh Patel	18/02/2025	Resolved accuracy issue

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