utility systems are maintained in accordance with regulatory requirements. They are also responsible for addressing any issues or failures in the utility systems that may affect regulatory compliance.

Quality Assurance (QA) Team: Responsible for reviewing documentation, conducting audits, and ensuring that utility systems meet regulatory standards. The QA team also ensures that any non-compliance is identified and corrected in a timely manner.

Production Team: Responsible for reporting any issues with utility systems that may affect production and ensuring that utilities are used in accordance with established procedures to maintain regulatory compliance.

4. Accountability

The Manufacturing Manager is accountable for ensuring that all utility systems are in compliance with regulatory standards. The overall compliance with this SOP is overseen by the Quality Assurance (QA) Manager.

5. Procedure

5.1. Identifying Applicable Regulatory Standards

1. Review the relevant local and international regulatory guidelines, including GMP, FDA, and ISO standards, to determine the specific compliance requirements for each utility system used in aerosol manufacturing.
2. Identify any new regulatory requirements that may impact utility systems or manufacturing processes. Update internal procedures to ensure compliance with these regulations.
3. Ensure that all regulatory requirements are clearly documented and communicated to all relevant departments, including Engineering, Maintenance, Production, and QA.

5.2. Ensuring Compliance During Design and Installation

1. Ensure that utility systems are designed and installed according to the applicable regulatory standards. This includes verifying that the systems meet the required specifications for performance, safety, and environmental considerations.
2. Verify that all components of the utility systems, such as pipes, tanks, regulators, filters, and pumps, comply with the regulatory standards for materials, construction, and safety.
3. Conduct a review of the system’s design documentation to ensure it aligns with the regulatory requirements before installation begins.

5.3. Verifying Compliance During Operation

1. Monitor the performance of utility systems on a regular basis to ensure they are operating within the specified parameters. This includes measuring parameters such as water pressure, flow rates, gas purity, temperature, humidity, and system integrity.
2. Ensure that utility systems are inspected and maintained according to the regulatory standards and that all maintenance records are properly documented and up-to-date.
3. Conduct routine audits of utility systems to verify that they are being operated and maintained in compliance with regulatory requirements. These audits should be documented and reviewed by the QA team.

5.4. Documenting Compliance

1. Maintain accurate records of all utility system inspections, tests, and audits. These records should include:
   • Details of the system tested (e.g., water system, compressed air system)
   • Test results and measurements
   • Inspection and maintenance logs
   • Corrective actions taken for any non-compliance issues
   • Signatures of the personnel performing the tests and audits
2. Ensure that all compliance documentation is reviewed and approved by the QA team before being filed for archiving.
3. Archive all compliance-related records for the required duration as per regulatory requirements or company policies.

5.5. Correcting Non-Compliance

1. If non-compliance is identified during any inspection, audit, or test, document the issue in the Deviation Log (Annexure-2). This log should include:
   • A description of the non-compliance issue
   • The cause of the issue (if known)
   • Corrective actions taken to resolve the issue
   • The personnel responsible for the corrective actions
2. Implement corrective actions to resolve non-compliance issues and verify that the actions taken address the root cause. Once corrective actions are completed, verify that the system is operating in compliance with regulatory standards.
3. Once corrective actions are implemented, perform additional verification testing to ensure that the utility system meets regulatory standards. Document the results and update the Deviation Log.

6. Abbreviations

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

7. Documents

1. Utility Compliance Verification 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
• ISO 9001 – Quality Management Systems

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Utility Compliance Verification Report

System ID	Model Number	Serial Number	Test Date	Test Type	Result
Water-001	Model A	SN123456	06/02/2025	Flow Rate Test	Pass
Air-002	Model B	SN987654	06/02/2025	Pressure Test	Pass

Annexure-2: Deviation Log

Deviation ID	Deviation Description	Corrective Action	Assigned To	Status
DEV-12345	Water system pressure deviation	Adjusted water pump pressure	Rajesh Patel	Completed

Annexure-3: Corrective Action Log

Action ID	Action Description	Responsible Person	Completion Date
CA-12345	Recalibrated pressure regulator	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 compliance verification procedures	To comply with updated GMP regulations	Anjali Sharma	Page 1	[Ref Point]	Updated procedures