Procedure for Validation of Electrical Utilities
| Department | Quality Assurance (QA)/Validation/Engineering/Production |
|---|---|
| SOP No. | SOP/Ointment/145 |
| 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 systematic approach for validating electrical utilities used in pharmaceutical manufacturing. Validation of electrical utilities ensures uninterrupted power supply, stable voltage, and reliable backup systems to support critical production and laboratory operations.
2. Scope
This SOP applies to all personnel in the Quality Assurance (QA), Validation, Engineering, and Production departments responsible for the qualification, validation, and monitoring of electrical utilities.
3. Responsibilities
- QA Officer: Ensures compliance with electrical utilities validation protocols.
- Validation Team: Develops and executes electrical utilities validation protocols.
- Engineering Team: Maintains and calibrates electrical systems.
- Production Supervisor: Ensures validated electrical utilities are maintained.
- QA Manager: Reviews and approves validation reports for electrical utilities.
4. Accountability
The QA and Engineering Managers are accountable for ensuring that electrical utility validation is conducted as per GMP, FDA, ICH, and WHO guidelines.
5. Procedure
5.1 Phases of Electrical Utilities Validation
Validation of electrical utilities consists of three key phases:
- Installation Qualification (IQ): Ensures electrical systems are installed as per design specifications.
- Operational Qualification (OQ): Confirms that electrical utilities function within defined operational parameters.
- Performance Qualification (PQ):
Verifies that electrical utilities consistently meet operational requirements under real production conditions.
5.2 Installation Qualification (IQ)
- Verify the installation of electrical components, including:
- Main power distribution panels
- Transformers and circuit breakers
- Uninterruptible Power Supply (UPS) and backup generators
- Electrical grounding systems
- Ensure proper labeling of electrical circuits and panels.
- Check system wiring for compliance with safety regulations.
- Document installation records and approve IQ reports.
5.3 Operational Qualification (OQ)
- Test the electrical system under standard operating conditions.
- Monitor critical parameters such as:
- Voltage stability (±5% of nominal voltage)
- Power load capacity
- Backup power switching time
- Emergency shutdown functionality
- Perform circuit breaker trip testing.
- Confirm uninterrupted power supply for critical equipment.
- Record OQ data and approve reports before proceeding to PQ.
5.4 Performance Qualification (PQ)
- Assess electrical system stability over an extended period.
- Monitor power quality parameters continuously for at least 30 days.
- Ensure compliance with:
- GMP requirements for power stability
- Uninterrupted operation of essential equipment
- Emergency backup power activation within required time
- Document and approve PQ results before final validation approval.
5.5 Routine Monitoring and Revalidation
- Schedule routine monitoring of voltage levels and load capacity.
- Conduct periodic revalidation after major electrical upgrades or maintenance.
- Ensure continuous logging of power quality parameters.
5.6 Handling Deviations
- If electrical utilities fail validation criteria:
- Identify root cause and document findings.
- Implement corrective and preventive actions (CAPA).
- Requalify the electrical system after necessary adjustments.
- Maintain deviation records for regulatory audits.
5.7 Documentation and Review
- Maintain all validation records in the Electrical Utilities Validation Log.
- QA must review and approve all validation reports.
- Ensure records are available for regulatory inspections.
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- IQ – Installation Qualification
- OQ – Operational Qualification
- PQ – Performance Qualification
- CAPA – Corrective and Preventive Actions
- UPS – Uninterruptible Power Supply
7. Documents
- Electrical Utilities Validation Protocol (Annexure-1)
- Electrical Utilities Validation Log (Annexure-2)
8. References
- ICH Q7 – Good Manufacturing Practice Guide
- WHO Guidelines for Electrical System Validation
- US FDA Guidance on Electrical Utilities in Pharmaceutical Facilities
- ISO 50001: Energy 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: Electrical Utilities Validation Protocol
| Electrical Parameter | Validation Phase | Test Method | Acceptance Criteria |
|---|---|---|---|
| Voltage Stability | OQ | Voltage Meter | ±5% of nominal voltage |
| Backup Power Response | PQ | Power Interruption Test | Backup activated within 10 sec |
Annexure-2: Electrical Utilities Validation Log
| Date | System ID | Validation Phase | Test Performed | Result | Reviewed By |
|---|---|---|---|---|---|
| 01/02/2025 | ELEC-1001 | IQ | Installation Verification | Pass | QA Manager |
| 02/02/2025 | GEN-2002 | PQ | Backup Power Test | Pass | QA Manager |