Procedure for Conducting Periodic Revalidation of Utilities

Department	Quality Assurance (QA)/Validation/Engineering
SOP No.	SOP/Ointment/150
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 a structured approach for conducting periodic revalidation of utilities used in pharmaceutical manufacturing. Revalidation ensures continued compliance with Good Manufacturing Practices (GMP) and maintains the reliability and efficiency of utilities such as HVAC, water systems, compressed air, and electrical supply.

2. Scope

This SOP applies to all personnel in the Quality Assurance (QA), Validation, and Engineering departments responsible for planning, executing, and reviewing utility revalidation activities.

3. Responsibilities

• QA Officer: Ensures that revalidation activities are conducted as per regulatory requirements.
• Validation Team: Develops revalidation protocols and executes validation activities.
• Engineering Team: Performs system inspections, maintenance, and repairs.
• Production Supervisor: Ensures validated utilities are used in manufacturing.
• QA Manager: Reviews and approves revalidation reports.

4. Accountability

The QA and Engineering Managers are accountable for ensuring that utility revalidation is conducted per GMP, FDA, ICH, and WHO guidelines.

5. Procedure

5.1 Identification of Utilities for Revalidation

• Utilities requiring periodic revalidation include:
  • HVAC Systems: Temperature and humidity control, pressure differentials, airflow patterns.
  • Water Systems: Conductivity, microbial count, Total Organic Carbon (TOC), endotoxin levels.
  • Compressed Air: Pressure stability, moisture control, oil-free air quality.
  • Electrical Supply: Voltage stability, power backup efficiency, emergency power supply validation.
• Revalidation must be scheduled based on risk assessment and regulatory requirements.

5.2 Revalidation Frequency

• Annually: Water systems, compressed air quality.
• Every 2 Years: HVAC validation, HEPA filter integrity tests.
• Every 3 Years: Electrical backup power system revalidation.

5.3 Preparation for Revalidation

• Develop a revalidation plan, including:
  • Objective and scope of revalidation.
  • Acceptance criteria.
  • Required resources.
  • Test procedures.
• Ensure proper scheduling to avoid production disruptions.
• Obtain approval from QA before initiating revalidation.

5.4 Execution of Revalidation Tests

• Perform validation tests as per the approved protocol.
• Ensure data integrity and accuracy in recording results.
• Verify compliance with acceptance criteria for each utility.

5.5 Review of Revalidation Data

• Analyze results to confirm utility performance consistency.
• Identify deviations and document corrective actions if required.
• Submit findings to QA for final approval.

5.6 Documentation and Record-Keeping

• Maintain revalidation reports, test results, and supporting data.
• Store documents securely for regulatory audits.
• Ensure all records are reviewed and approved by QA.

6. Abbreviations

• GMP – Good Manufacturing Practices
• QA – Quality Assurance
• HVAC – Heating, Ventilation, and Air Conditioning
• TOC – Total Organic Carbon
• CAPA – Corrective and Preventive Actions
• OOS – Out of Specification

7. Documents

• Utility Revalidation Plan (Annexure-1)
• Revalidation Report (Annexure-2)

8. References

• ICH Q7 – Good Manufacturing Practice Guide
• WHO Guidelines for Utility Validation
• US FDA Guidance on Periodic Revalidation

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 Revalidation Plan

Utility Type	Revalidation Frequency	Parameters to be Tested	Acceptance Criteria
HVAC	Every 2 Years	Temperature, Airflow	± 2°C, Proper Distribution
Water System	Annually	Conductivity, TOC	≤ 1.3 µS/cm, TOC ≤ 500 ppb

Annexure-2: Revalidation Report

Date	Utility Type	Revalidation Test	Results	Reviewed By
01/02/2025	Compressed Air	Moisture Content	Pass	QA Manager
02/02/2025	Electrical Supply	Backup System Activation	Pass	QA Manager