SOP for Ensuring Compliance with Utility Validation Standards – V 2.0

Procedure for Ensuring Compliance with Utility Validation Standards

Department	Quality Assurance (QA)/Validation/Engineering
SOP No.	SOP/Ointment/149
Supersedes	V 1.0
Page No.	Page X of Y
Issue Date	[Insert Issue Date]
Effective Date	[Insert Effective Date]
Review Date	[Insert Review Date]

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to define the procedures and requirements to ensure compliance with utility validation standards in pharmaceutical manufacturing. Compliance with validation standards ensures that utilities such as HVAC, water systems, compressed air, and electrical supply meet regulatory requirements for Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all personnel in the Quality Assurance (QA), Validation, and Engineering departments responsible for ensuring compliance with utility validation standards.

3. Responsibilities

QA Officer: Ensures that utility validation procedures comply with regulatory guidelines.
Validation Team: Develops and updates utility validation protocols.
Engineering Team: Monitors and maintains validated utility systems.
Production Supervisor: Ensures that validated utilities are used in manufacturing processes.
QA Manager: Reviews and approves validation compliance reports.

4. Accountability

The QA and Engineering Managers are accountable for ensuring that utility validation complies with GMP, FDA, ICH, and WHO guidelines.

5. Procedure

5.1 Understanding Regulatory Standards

Ensure compliance with the following regulations and guidelines:
- ICH Q7 – GMP Guidelines for Pharmaceutical Manufacturing
- WHO Guidelines for Water and Air Systems
- US FDA Guidance on Pharmaceutical Utilities
- ISO 8573-1:

Compressed Air Purity Standards

Regularly update compliance requirements as per changes in regulations.

5.2 Utility Validation Protocols

Develop validation protocols for:
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
Ensure protocols include acceptance criteria and test procedures.
Obtain approval for validation protocols from QA and regulatory teams.

5.3 Conducting Utility Validation

Perform validation of:
- HVAC Systems: Monitor airflow, temperature, and pressure differentials.
- Water Systems: Test for microbial contamination, TOC, and endotoxins.
- Compressed Air: Ensure oil-free, moisture-controlled, and microbe-free air supply.
- Electrical Utilities: Validate voltage stability and backup power systems.
Ensure validation tests meet predefined acceptance criteria.

5.4 Continuous Monitoring for Compliance

Set up real-time monitoring systems for critical utilities.
Implement scheduled monitoring for utility performance.
Maintain records of monitoring results in utility validation logs.

5.5 Handling Non-Compliance and Deviations

Identify deviations from validation parameters.
Perform root cause analysis (RCA) for deviations.
Initiate Corrective and Preventive Actions (CAPA) to address issues.
Revalidate affected utilities before resuming use.

5.6 Documentation and Record-Keeping

Maintain complete records of:
- Validation protocols and reports
- Monitoring data
- Deviation and CAPA reports
Ensure records are reviewed and approved by QA.
Keep records accessible for regulatory inspections.

6. Abbreviations

GMP – Good Manufacturing Practices
QA – Quality Assurance
HVAC – Heating, Ventilation, and Air Conditioning
TOC – Total Organic Carbon
CAPA – Corrective and Preventive Actions
RCA – Root Cause Analysis

7. Documents

Utility Validation Compliance Report (Annexure-1)
CAPA Log for Utility Deviations (Annexure-2)

8. References

ICH Q7 – Good Manufacturing Practice Guide
WHO Guidelines for Utility Validation
US FDA Guidance on Pharmaceutical Utilities
ISO 8573-1: Compressed Air Purity Standards

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 Compliance Report

Date	Utility Type	Validation Test	Compliance Status	Reviewed By
01/02/2025	HVAC	Temperature & Airflow	Compliant	QA Manager
02/02/2025	Water System	Microbial Testing	Compliant	QA Manager

Annexure-2: CAPA Log for Utility Deviations

Date	Utility Type	Deviation	Root Cause	Corrective Action	Reviewed By
01/02/2025	Compressed Air	Excess Moisture Detected	Filter Saturation	Filter Replacement	QA Manager
02/02/2025	Electrical Supply	Voltage Instability	Power Grid Fluctuations	UPS Calibration	QA Manager