they are compliant with GMP standards and regulatory requirements.

Maintenance Team: Responsible for maintaining equipment in optimal working condition and ensuring that any corrective actions arising from equipment qualification are addressed.

4. Accountability

The Manufacturing Manager is accountable for ensuring that equipment qualification reports are prepared and documented as per this SOP. The overall compliance with this SOP is overseen by the Quality Assurance (QA) Manager.

5. Procedure

5.1. Preparing the Equipment Qualification Report

1. Before beginning the qualification process, ensure that the equipment is installed and operational as per the Installation Qualification (IQ) standards.
2. For each qualification phase (IQ, OQ, PQ), ensure that all test procedures are documented, including test methods, acceptance criteria, equipment details, test conditions, and any deviations observed during testing.
3. Include the following sections in the qualification report:
   • Introduction: Brief overview of the equipment being qualified, including its model, serial number, and intended use in aerosol manufacturing.
   • Test Objectives: The specific goals of the qualification process (e.g., verifying equipment performance, ensuring compliance with specifications, confirming proper installation and operation).
   • Test Methodology: A detailed description of the test methods, procedures, and instruments used during the qualification process, including any calibration or validation protocols followed.
   • Acceptance Criteria: The criteria that must be met for the equipment to be considered qualified (e.g., performance tolerance, speed, accuracy).
   • Results: Document the results of each test performed, including numerical values, pass/fail status, and any relevant observations.
   • Deviation Log: If any deviations from the expected results or protocols occur, document them here. Include the corrective actions taken to address the deviations and the outcomes of those actions.
   • Conclusion: Summary of the qualification results, including whether the equipment meets the specified criteria and is ready for use in production.
   • Approval Section: Signature of the personnel performing the qualification and those reviewing and approving the qualification results.
4. Ensure that all data recorded in the qualification report is accurate and complete.

5.2. Documenting Deviations

1. If any deviations occur during the qualification process, they must be documented in the Deviation Log (Annexure-1). The log should include the following:
   • Deviation ID
   • Deviation description
   • Cause of the deviation
   • Corrective action taken
   • Verification of the corrective action
   • Status of the deviation (e.g., resolved, pending)
2. Ensure that all deviations are addressed and that corrective actions are verified and documented in the qualification report.

5.3. Reviewing and Approving the Equipment Qualification Report

1. The QA team should review the Equipment Qualification Report to ensure that it meets all applicable standards and that all test results, deviations, and corrective actions are appropriately documented.
2. Ensure that all sections of the report are filled out, and the information is clear and concise. The report should be easy to interpret for future audits or reviews.
3. The QA team should approve the report once all tests have been performed, any deviations have been addressed, and the equipment is confirmed to meet the acceptance criteria.

5.4. Archiving the Equipment Qualification Report

1. Once the Equipment Qualification Report is approved, ensure that it is stored in a secure, controlled location with access limited to authorized personnel.
2. All documentation related to the qualification process, including the test results, deviation logs, and corrective actions, should be archived for future reference and audits.
3. Maintain records in accordance with GMP and regulatory requirements for a defined retention period, ensuring that they are available for review by regulatory bodies when necessary.

6. Abbreviations

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

7. Documents

1. Equipment Qualification Report (Annexure-1)
2. Deviation Log (Annexure-2)
3. Corrective Action 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 Qualification Report

Equipment ID	Model Number	Serial Number	Test Date	Test Type	Result
FILL-001	Model A	SN123456	06/02/2025	IQ Test	Pass
FILL-001	Model A	SN123456	06/02/2025	OQ Test	Pass

Annexure-2: Deviation Log

Deviation ID	Deviation Description	Corrective Action	Assigned To	Status
DEV-12345	Calibration deviation	Recalibrated equipment	Rajesh Patel	Completed

Annexure-3: Corrective Action Log

Action ID	Action Description	Responsible Person	Completion Date
CA-12345	Recalibrated equipment	Rajesh Patel	06/02/2025

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 documentation and corrective action procedures	To comply with updated GMP regulations	Anjali Sharma	Page 1	[Ref Point]	Updated procedures