SOP for Documenting Utility Validation Data

Department	Aerosol
SOP No.	SOP/Aerosol/147/2025
Supersedes	SOP/Aerosol/147/2022
Page No.	Page 1 of Y
Issue Date	06/02/2025
Effective Date	16/02/2025
Review Date	06/02/2028

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to outline the process for documenting utility validation data in aerosol manufacturing. Proper documentation of utility validation is critical to demonstrate compliance with regulatory requirements and ensure that utilities (such as water, compressed air, gas, and electricity) are functioning within the specified parameters for safe and effective manufacturing operations. This SOP provides a structured approach for recording validation data, including the methods for testing, documentation standards, and review procedures.

2. Scope

This SOP applies to all utilities used in aerosol manufacturing processes, including water systems, compressed air systems, HVAC, and other systems that are critical to the production environment. The scope includes documentation requirements for utility qualification, including installation, operational, and performance qualification data, and all associated records related to validation testing and results.

3. Responsibilities

• Engineering Team: Responsible for performing utility system validations, including data collection during qualification tests, and ensuring that the utility systems meet the required specifications.
• Quality Assurance (QA) Team: Responsible for reviewing and approving all validation documentation to ensure compliance with GMP and regulatory standards.
• Production Team: Responsible for reporting any issues or deviations related to utility systems that could affect product quality and ensuring that all utility-related procedures are followed during production.
• Maintenance Team: Responsible for maintaining utility systems, ensuring their continued operational functionality, and supporting the documentation of any maintenance activities affecting system performance.

4. Accountability

The Manufacturing Manager is accountable for ensuring that all utility systems are properly validated and that documentation is maintained according to this SOP. The overall compliance with this SOP is overseen by the Quality Assurance (QA) Manager.

5. Procedure

5.1. Utility Validation Documentation

1. Ensure that the utility validation is conducted according to the manufacturer’s specifications and relevant standards for each utility system. The validation process should include:
   • Installation Qualification (IQ): Verify that the utility system has been installed according to specifications and design requirements.
   • Operational Qualification (OQ): Verify that the system operates within the specified parameters under normal operating conditions.
   • Performance Qualification (PQ): Confirm that the system performs as expected over an extended period and under actual operating conditions.
2. During each qualification phase, collect relevant data that demonstrates the system is functioning as intended. This data may include:
   • Flow rates, pressures, temperatures, and other performance indicators
   • Test results from system performance checks
   • Maintenance records, including any corrective actions taken
3. Ensure that all data is recorded in a structured and consistent manner, following the approved templates and formats for utility validation documentation.

5.2. Data Collection and Entry

1. For each utility system, create a dedicated data log to record test results and performance data. The log should include:
   • System ID, installation location, and operational parameters
   • The test type (e.g., temperature, pressure, flow rate) and corresponding results
   • The name and signature of the personnel performing the validation tests
   • The date and time of each test
2. Ensure that all data entries are legible, accurate, and supported by any relevant calibration or testing equipment used. Any deviations from expected results should be documented and investigated.
3. All logs should be signed by the responsible personnel and reviewed by the QA team for completeness and compliance with regulatory requirements.

5.3. Documentation Review and Approval

1. Once the utility validation data has been collected and entered into the system, the documentation should be reviewed by the QA team for compliance with internal and regulatory standards.
2. The QA team should ensure that:
   • The utility systems meet the necessary specifications for functionality and performance
   • All required tests were performed and the results are within the acceptable ranges
   • Any deviations or corrective actions taken are properly documented
3. Once reviewed, the QA team should approve the documentation and sign off on the validation records. Any unresolved issues should be addressed before final approval.

5.4. Archiving and Retention of Validation Data

1. Once approved, all utility validation data should be stored in a secure, accessible location for future reference and audits.
2. Ensure that all validation records are retained for the required duration, in accordance with regulatory requirements and company policies.
3. Implement a system for retrieving and reviewing validation records during internal audits, regulatory inspections, or whenever necessary to demonstrate compliance with GMP standards.

5.5. Periodic Review of Utility Systems

1. Periodic reviews of the utility systems should be conducted to ensure they continue to perform as required. This includes requalification testing and ensuring that the documentation remains up-to-date with any changes to the utility systems.
2. Any changes or updates to the utility systems that impact performance, compliance, or validation status should be documented and reviewed in the Change Control Log (Annexure-2).

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 Validation Data Log (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 Validation Data Log

System ID	Test Type	Test Date	Result	Deviation (if any)	Corrective Action	Responsible Person
Water-001	Flow Rate	06/02/2025	Pass	N/A	N/A	Rajesh Patel
Air-002	Pressure Test	06/02/2025	Pass	N/A	N/A	Anjali Sharma

Annexure-2: Deviation Log

Deviation ID	Deviation Description	Corrective Action	Assigned To	Status
DEV-12345	Water pressure low	Adjusted water pressure regulator	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 utility documentation procedures	To comply with updated GMP regulations	Anjali Sharma	Page 1	[Ref Point]	Updated procedures