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 |