Standard Operating Procedure for Monitoring Power Supply Stability in Biosimilar Manufacturing
| Department | Biosimilars |
|---|---|
| SOP No. | SOP/BS/123/2025 |
| Supersedes | SOP/BS/123/2022 |
| Page No. | Page 1 of 11 |
| Issue Date | 04/05/2025 |
| Effective Date | 06/05/2025 |
| Review Date | 04/05/2026 |
1. Purpose
To define a standardized procedure for monitoring power supply stability in the biosimilar upstream manufacturing area to prevent equipment malfunction, ensure continuous operations, and comply with GMP infrastructure requirements.
2. Scope
This SOP applies to all power-dependent systems including bioreactors, incubators, centrifuges, HVAC, SCADA, and cold storage equipment used in biosimilar manufacturing facilities.
3. Responsibilities
- Engineering Department: Perform routine checks on voltage, phase, and UPS function. Maintain logs.
- Production: Notify Engineering and QA of any power-related abnormalities.
- QA: Review and verify power stability records as part of facility qualification and batch release.
4. Accountability
The Head of Engineering is accountable for ensuring uninterrupted, regulated power supply to all critical biosimilar equipment and for reporting any power anomalies to QA and Site Management.
5. Procedure
5.1 Monitoring Parameters and Frequency
- Monitor and record the following at defined frequencies:
- Voltage Stability (230V ± 5%) – Daily
- Frequency Stability (50 Hz ± 0.5 Hz) – Weekly
- UPS Battery Voltage and Load – Weekly
- Generator and Switchgear Function – Monthly
5.2 Equipment and Tools Used
- Digital Power Analyzer with data logger
- UPS monitoring software
- Manual voltmeters for cross-checks
5.3 Logging and Reporting
- Record daily voltage and frequency values in Annexure-1: Power Monitoring Log.
- Log UPS diagnostic reports weekly in Annexure-2.
- Any deviation from acceptable limits must be escalated immediately to Site Head and QA.
5.4 Action in Case of Power Instability
- If fluctuations exceed limits:
- Isolate affected equipment immediately.
- Switch to backup power or stabilize via UPS.
- Document incident in Annexure-3 and initiate deviation report.
- Engineering must perform root cause analysis within 24 hours.
5.5 Preventive Measures
- Schedule quarterly maintenance of power panels and UPS units.
- Maintain clean electrical panels and cable routing.
- Ensure 24×7 auto-alarm notifications are enabled for UPS and generators.
6. Abbreviations
- UPS: Uninterruptible Power Supply
- Hz: Hertz
- QA: Quality Assurance
- GMP: Good Manufacturing Practice
7. Documents
- Power Monitoring Log – Annexure-1
- UPS Performance Log – Annexure-2
- Power Deviation Report – Annexure-3
8. References
- WHO Annex 5: GMP for HVAC and Power Infrastructure
- ICH Q9 – Quality Risk Management
- IS 732 – Code of Practice for Electrical Wiring Installations
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Power Monitoring Log
| Date | Voltage (V) | Frequency (Hz) | Logged By | Remarks |
|---|---|---|---|---|
| 04/05/2025 | 229.5 | 49.9 | Sunita Reddy | Within range |
Annexure-2: UPS Performance Log
| Date | Battery Voltage | Load % | Backup Time | Tested By |
|---|---|---|---|---|
| 02/05/2025 | 230V | 45% | 40 mins | Ajay Verma |
Annexure-3: Power Deviation Report
| Date | Incident | Action Taken | Root Cause | Preventive Measure |
|---|---|---|---|---|
| 01/05/2025 | Voltage Drop | Switched to UPS | External Grid Dip | Installed AVR |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 04/05/2025 | 2.0 | Added UPS log and deviation reporting process | Audit recommendation |