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

1. 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

1. Digital Power Analyzer with data logger
2. UPS monitoring software
3. Manual voltmeters for cross-checks

5.3 Logging and Reporting

1. Record daily voltage and frequency values in Annexure-1: Power Monitoring Log.
2. Log UPS diagnostic reports weekly in Annexure-2.
3. Any deviation from acceptable limits must be escalated immediately to Site Head and QA.

5.4 Action in Case of Power Instability

1. 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.
2. Engineering must perform root cause analysis within 24 hours.

5.5 Preventive Measures

1. Schedule quarterly maintenance of power panels and UPS units.
2. Maintain clean electrical panels and cable routing.
3. 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

1. Power Monitoring Log – Annexure-1
2. UPS Performance Log – Annexure-2
3. 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